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1. Matrix Metalloproteinase-2 and CKD Progression: The Chronic Renal Insufficiency Cohort (CRIC) Study

Author

Robin L. Baudier, Paula F. Orlandi, Wei Yang, Hsiang-Yu Chen, Nisha Bansal, J. Walker Blackston, Jing Chen, Rajat Deo, Mirela Dobre, Hua He, Jiang He, Ana C. Ricardo, Tariq Shafi, Anand Srivastava, Dawei Xie, Katalin Susztak, Harold I. Feldman, Amanda H. Anderson, Lawrence J. Appel, MD, Debbie Cohen, MD, Laura Dember, MD, Alan S. Go, MD, James P. Lash, MD, Robert G. Nelson, MD, PhD, Mahboob Rahman, MD, Panduranga S. Rao, MD, Vallabh O. Shah, PhD, and Mark L. Unruh, MD

Subjects
Matrix metalloproteinase 2 (MMP-2), chronic kidney disease (CKD), CKD progression, initiation of kidney replacement therapy (KRT), eGFR slope, fibrosis, Diseases of the genitourinary system. Urology, RC870-923
Abstract

Rationale & Objective: Matrix metalloproteinase 2 (MMP-2) plays an important role in the development of fibrosis, the final common pathway of chronic kidney disease (CKD). This study aimed to assess the relationship between repeated measures of MMP-2 and CKD progression in a large, diverse prospective cohort. Study Design: In a prospective cohort of Chronic Renal Insufficiency Cohort (CRIC) participants (N = 3,827), MMP-2 was measured at baseline. In a case-cohort design, MMP-2 was additionally measured at year 2 in a randomly selected subcohort and cases of estimated glomerular filtration rate (eGFR) halving or kidney replacement therapy (KRT) (N = 1,439). Setting & Participants: CRIC is a multicenter prospective cohort of adults with CKD. Exposure: MMP-2 measured in plasma at baseline and at year 2. Outcomes: A composite kidney endpoint (KRT/eGFR halving) Analytical Approach: Weighted Cox proportional hazards models for case-cohort participants. Results: Participants were followed for a median of 4.6 years from year 2 and 6.9 years from the baseline. Persistently elevated MMP-2 (≥300 ng/mL at both baseline and year 2) increased the hazard of the composite kidney endpoint (HR, 1.61; 95% CI, 1.07-2.42; P = 0.09) after adjusting for covariates. The relationship of persistently elevated MMP-2 was modified by levels of inflammation, with a 2.6 times higher rate of the composite kidney endpoint in those with high-sensitivity C-reactive protein

Published
2024
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2. Evaluation of the effect of sodium zirconium cyclosilicate on arrhythmia-related cardiovascular outcomes in patients receiving chronic haemodialysis with hyperkalaemia: protocol for the multicentre, randomised, controlled DIALIZE-Outcomes study

Author

Michel Jadoul, Steven Fishbane, Laura Dember, CP Kovesdy, Ayman Al-Shurbaji, Vera Lisovskaja, Priya Sekar, Brian Katona, Nicolas Guzman, and Charles Herzog

Subjects
Medicine
Abstract

Introduction Patients with kidney failure receiving chronic haemodialysis have elevated risk of arrhythmias potentially increasing the likelihood of sudden cardiac death, stroke and hospitalisation. The DIALIZE study (NCT03303521) demonstrated that sodium zirconium cyclosilicate (SZC) was an efficacious and well-tolerated treatment for predialysis hyperkalaemia in patients undergoing haemodialysis. The DIALIZE-Outcomes study evaluates the effect of SZC on sudden cardiac death and arrhythmia-related cardiovascular outcomes in patients receiving chronic haemodialysis with recurrent hyperkalaemia.Methods and analysis International, multicentre, randomised, double-blind, placebo-controlled study conducted at 357 study sites across 25 countries. Adults (≥18 years) receiving chronic haemodialysis three times per week with recurrent predialysis serum potassium (K+) ≥5.5 mmol/L post long interdialytic interval (LIDI) are eligible. Patients (~2800) will be randomised 1:1 to SZC or placebo, starting at 5 g orally once daily on non-dialysis days and titrated weekly in 5 g increments (maximum 15 g) to target predialysis serum K+ 4.0–5.0 mmol/L post LIDI. The primary objective is to evaluate efficacy of SZC versus placebo in reducing occurrence of the primary composite endpoint of sudden cardiac death, stroke or arrhythmia-related hospitalisation, intervention or emergency department visit. Secondary endpoints include efficacy of SZC versus placebo in maintaining normokalaemia (serum K+ 4.0–5.5 mmol/L post LIDI) at the 12-month visit, preventing severe hyperkalaemia (serum K+ ≥6.5 mmol/L post LIDI) at the 12-month visit and reducing the incidence of individual cardiovascular outcomes. Safety of SZC will be evaluated. The study is event driven, with participants remaining in the study until 770 primary endpoint events have occurred. Average time in the study is expected to be ~25 months.Ethics and dissemination Approval was obtained from the relevant institutional review board/independent ethics committee from each participating site (approving bodies in supplementary information). The results will be submitted to a peer-reviewed journal.Trial registration numbers EudraCT 2020-005561-14 and clinicaltrials.gov identifier NCT04847232.

Published
2023
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3. Cultivating Innovative Pragmatic Cluster-Randomized Registry Trials Embedded in Hemodialysis Care: Workshop Proceedings From 2018

Author

Elliot J. Lee, Aakil Patel, Rey R. Acedillo, Jovina C. Bachynski, Ian Barrett, Erika Basile, Marisa Battistella, Derek Benjamin, David Berry, Peter G. Blake, Patricia Chan, Clara J. Bohm, Kristin K. Clemens, Charles Cook, Laura Dember, Jade S. Dirk, Stephanie Dixon, Elisabeth Fowler, Leah Getchell, Nazanine Gholami, Cory Goldstein, Emma Hahn, Betty Hogeterp, Susan Huang, Michelle Hughes, Meg J. Jardine, Shasikara Kalatharan, Shane Kilburn, Eduardo Lacson, Sean Leonard, Channing Liberty, Craig Lindsay, Jennifer M. MacRae, Braden J. Manns, Janice McCallum, Christopher W. McIntyre, Amber O. Molnar, Reem A. Mustafa, Gihad E. Nesrallah, Matthew J. Oliver, Michael Pandes, Sanjay Pandeya, Malvinder S. Parmar, Elijah Z. Rabin, Johnathan Riley, Samuel A. Silver, Jessica M. Sontrop, Manish M. Sood, Rita S. Suri, Navdeep Tangri, Daniel J. Tascona, Alison Thomas, Ron Wald, Michael Walsh, Charles Weijer, Matthew A. Weir, Hans Vorster, Deborah Zimmerman, and Amit X. Garg

Subjects
Diseases of the genitourinary system. Urology, RC870-923
Abstract

Hemodialysis is a life-sustaining treatment for persons with kidney failure. However, those on hemodialysis still face a poor quality of life and a short life expectancy. High-quality research evidence from large randomized controlled trials is needed to identify interventions that improve the experiences, outcomes, and health care of persons receiving hemodialysis. With the support of the Canadian Institutes of Health Research and its Strategy for Patient-Oriented Research, the Innovative Clinical Trials in Hemodialysis Centers initiative brought together Canadian and international kidney researchers, patients, health care providers, and health administrators to participate in a workshop held in Toronto, Canada, on June 2 and 3, 2018. The workshop served to increase knowledge and awareness about the conduct of innovative, pragmatic, cluster-randomized registry trials embedded into routine hemodialysis care and provided an opportunity to discuss and build support for new trial ideas. The workshop content included structured presentations, facilitated group discussions, and expert panel feedback. Partnerships and promising trial ideas borne out of the workshop will continue to be developed to support the implementation of future large-scale trials.

Published
2019
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5. What Patients Teach Us About Patient Engagement in Research

Author

Laura Dember

Subjects
Adult, Male, Transplantation, Biomedical Research, Epidemiology, Middle Aged, Critical Care and Intensive Care Medicine, Editorial, Attitude, Caregivers, Nephrology, Humans, Female, Original Article, Renal Insufficiency, Chronic, Patient Participation, Aged
Abstract

BACKGROUND AND OBJECTIVES: Although patient and caregiver involvement in research is widely advocated to improve the relevance and uptake of study findings, barriers and uncertainties in achieving this goal remain. This study aimed to describe patient and caregiver experiences and perspectives of their previous involvement in research, to inform strategies to strengthen patient involvement in research. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Semistructured interviews were conducted with 23 adult patients with CKD and caregivers who had previously been involved in research, from Australia, the United States, the United Kingdom, and Denmark. Transcripts were analyzed thematically. RESULTS: We identified six themes: grappling with CKD diagnosis (overwhelmed by the burden of illness, silenced by stigma and shame, absence of advocacy, and awareness), bearing the responsibility for involvement (autonomy in their own care, forced to be proactive to access opportunities, infrastructural support to connect researchers and patients), battling big agendas (struggling in a system of disincentive, changing research culture, becoming equals), seeing the person behind the patient (harnessing broader knowledge, expertise, skills and interests, understanding patient needs, motivations for involvement), sensitivity to complexities of payment (accounting for individual circumstances, denoting value, enabling diverse involvement), and championing the patient voice (links to important stakeholders, drivers of innovation, responsibility to end users). CONCLUSIONS: The burden of CKD, limited opportunities, and power asymmetry between patients/caregivers and researchers were challenges to meaningful involvement in research. Building trust, awareness of opportunities, and recognizing the broad expertise and value of patients/caregivers, including and beyond their illness experience, may better support patient and caregiver involvement in research in CKD.

Published
2023

6. Evaluation of the effect of sodium zirconium cyclosilicate on arrhythmia-related cardiovascular outcomes in patients receiving chronic haemodialysis with hyperkalaemia: protocol for the multicentre, randomised, controlled DIALIZE-Outcomes study

Author

Steven Fishbane, Michel Jadoul, Laura Dember, CP Kovesdy, Ayman Al-Shurbaji, Vera Lisovskaja, Priya Sekar, Brian Katona, Nicolas Guzman, Charles Herzog, UCL - SSS/IREC/NEFR - Pôle de Néphrologie, and UCL - (SLuc) Service de néphrologie

Subjects
hyperkalaemia, sodium zirconium cyclosilicate, cardiovascular, potassium, General Medicine, arrhythmia, Dialysis, NEPHROLOGY, CARDIOLOGY, haemodialys
Abstract

IntroductionPatients with kidney failure receiving chronic haemodialysis have elevated risk of arrhythmias potentially increasing the likelihood of sudden cardiac death, stroke and hospitalisation. The DIALIZE study (NCT03303521) demonstrated that sodium zirconium cyclosilicate (SZC) was an efficacious and well-tolerated treatment for predialysis hyperkalaemia in patients undergoing haemodialysis. The DIALIZE-Outcomes study evaluates the effect of SZC on sudden cardiac death and arrhythmia-related cardiovascular outcomes in patients receiving chronic haemodialysis with recurrent hyperkalaemia.Methods and analysisInternational, multicentre, randomised, double-blind, placebo-controlled study conducted at 357 study sites across 25 countries. Adults (≥18 years) receiving chronic haemodialysis three times per week with recurrent predialysis serum potassium (K+) ≥5.5 mmol/L post long interdialytic interval (LIDI) are eligible. Patients (~2800) will be randomised 1:1 to SZC or placebo, starting at 5 g orally once daily on non-dialysis days and titrated weekly in 5 g increments (maximum 15 g) to target predialysis serum K+4.0–5.0 mmol/L post LIDI. The primary objective is to evaluate efficacy of SZC versus placebo in reducing occurrence of the primary composite endpoint of sudden cardiac death, stroke or arrhythmia-related hospitalisation, intervention or emergency department visit. Secondary endpoints include efficacy of SZC versus placebo in maintaining normokalaemia (serum K+4.0–5.5 mmol/L post LIDI) at the 12-month visit, preventing severe hyperkalaemia (serum K+≥6.5 mmol/L post LIDI) at the 12-month visit and reducing the incidence of individual cardiovascular outcomes. Safety of SZC will be evaluated. The study is event driven, with participants remaining in the study until 770 primary endpoint events have occurred. Average time in the study is expected to be ~25 months.Ethics and disseminationApproval was obtained from the relevant institutional review board/independent ethics committee from each participating site (approving bodies in supplementary information). The results will be submitted to a peer-reviewed journal.Trial registration numbersEudraCT 2020-005561-14 and clinicaltrials.gov identifierNCT04847232.

Published
2023

7. Kidney Disease, Hypertension Treatment, and Cerebral Perfusion and Structure

Author

Manjula Kurella Tamura, Sarah Gaussoin, Nicholas M. Pajewski, Greg Zaharchuk, Barry I. Freedman, Stephen R. Rapp, Alexander P. Auchus, William E. Haley, Suzanne Oparil, Jessica Kendrick, Christianne L. Roumie, Srinivasan Beddhu, Alfred K. Cheung, Jeff D. Williamson, John A. Detre, Sudipto Dolui, R. Nick Bryan, Ilya M. Nasrallah, Paul Whelton, Karen C. Johnson, Joni Snyder, Diane Bild, Denise Bonds, Nakela Cook, Jeffrey Cutler, Lawrence Fine, Peter Kaufmann, Paul Kimmel, Lenore Launer, Claudia Moy, William Riley, Laurie Ryan, Eser Tolunay, Song Yang, David Reboussin, Jeff Williamson, Walter T. Ambrosius, William Applegate, Greg Evans, Capri Foy, Dalane Kitzman, Mary Lyles, Nick Pajewski, Steve Rapp, Scott Rushing, Neel Shah, Kaycee M. Sink, Mara Vitolins, Lynne Wagenknecht, Valerie Wilson, Letitia Perdue, Nancy Woolard, Tim Craven, Katelyn Garcia, Laura Lovato, Jill Newman, James Lovato, Lingyi Lu, Chris McLouth, Greg Russell, Bobby Amoroso, Patty Davis, Jason Griffin, Darrin Harris, Mark King, Kathy Lane, Wes Roberson, Debbie Steinberg, Donna Ashford, Phyllis Babcock, Dana Chamberlain, Vickie Christensen, Loretta Cloud, Christy Collins, Delilah Cook, Katherine Currie, Debbie Felton, Stacy Harpe, Marjorie Howard, Michelle Lewis, Pamela Nance, Nicole Puccinelli-Ortega, Laurie Russell, Jennifer Walker, Brenda Craven, Candace Goode, Margie Troxler, Janet Davis, Sarah Hutchens, Anthony A. Killeen, Anna M. Lukkari, Robert Ringer, Brandi Dillard, Norbert Archibeque, Stuart Warren, Mike Sather, James Pontzer, Zach Taylor, Elsayed Z. Soliman, Zhu-Ming Zhang, Yabing Li, Chuck Campbell, Susan Hensley, Julie Hu, Lisa Keasler, Mary Barr, Tonya Taylor, Christos Davatzikos, Ilya Nasarallah, Lisa Desiderio, Mark Elliott, Ari Borthakur, Harsha Battapady, Guray Erus, Alex Smith, Ze Wang, Jimit Doshi, Jackson T. Wright, Mahboob Rahman, Alan J. Lerner, Carolyn Still, Alan Wiggers, Sara Zamanian, Alberta Bee, Renee Dancie, George Thomas, Martin Schreiber, Sankar Dass Navaneethan, John Hickner, Michael Lioudis, Michelle Lard, Susan Marczewski, Jennifer Maraschky, Martha Colman, Andrea Aaby, Stacey Payne, Melanie Ramos, Carol Horner, Paul Drawz, Pratibha P. Raghavendra, Scott Ober, Ronda Mourad, Muralidhar Pallaki, Peter Russo, Pratibha Raghavendra, Pual Fantauzzo, Lisa Tucker, Bill Schwing, John R. Sedor, Edward J. Horwitz, Jeffrey R. Schellling, John F. O’Toole, Lisa Humbert, Wendy Tutolo, Suzanne White, Alishea Gay, Walter Clark, Robin Hughes, Mirela Dobre, Carolyn H. Still, Monique Williams, Udayan Bhatt, Lee Hebert, Anil Agarwal, Melissa Brown Murphy, Nicole Ford, Cynthia Stratton, Jody Baxter, Alicia A. Lykins, Alison McKinley Neal Leena Hirmath, Osei Kwame, Kyaw Soe, William F. Miser, Colleen Sagrilla, Jan Johnston, Amber Anaya, Ashley Mintos, Angel A. Howell, Kelly Rogers, Sara Taylor, Donald Ebersbacher, Lucy Long, Beth Bednarchik, Adrian Schnall, Jonathan Smith, Lori Peysha, Lisa Leach, Megan Tribout, Carla Harwell, Pinkie Ellington, Mary Ann Banerji, Pranav Ghody, Melissa Vahídeh Rambaud, Raymond Townsend, Debbie Cohen, Yonghong Huan, Mark Duckworth, Virginia Ford, Juliet Leshner, Ann Davison, Sarah Vander Veen, Crystal A. Gadegbeku, Avi Gillespie, Anuradha Paranjape, Sandra Amoroso, Zoe Pfeffer, Sally B. Quinn, Jiang He, Jing Chen, Eva Lustigova, Erin Malone, Marie Krousel-Wood, Richard Deichmann, Patricia Ronney, Susan Muery, Donnalee Trapani, Michael Rocco, David Goff, Carlos Rodriguez, Laura Coker, Amret Hawfield, Joseph Yeboah, Lenore Crago, John Summerson, Anita Hege, Matt Diamond, Laura Mulloy, Marcela Hodges, Michelle Collins, Charlene Weathers, Heather Anderson, Emily Stone, Walida Walker, Andrew McWilliams, Michael Dulin, Lindsay Kuhn, Susan Standridge, Lindsay Lowe, Kelly Everett, Kelry Preston, Susan Norton, Silena Gaines, Ali A. Rizvi, Andrew W. Sides, Diamond Herbert, Matthew M. Hix, Melanie Whitmire, Brittany Arnold, Philip Hutchinson, Joseph Espiritu, Mark Feinglos, Eugene Kovalik, Georgianne Gedon-Lipscomb, Kathryn Evans, Connie Thacker, Ronna Zimmer, Mary Furst, MaryAnn Mason, James Powell, Paul Bolin, Junhong Zhang, Mary Pinion, Gail Davis, Winifred Bryant, Presley Phelps, Connie Garris-Sutton, Beatrice Atkinson, Gabriele Contreras, Maritza Suarez, Ivonne Schulman, Don Koggan, Jackie Vassallo, Gloria Peruyera, Sheri Whittington, Cassandra Bethea, Laura Gilliam, Carolyn Pedley, Geraldine Zurek, Miriam Baird, Charles Herring, Mary Martha Smoak, Julie Williams, Samantha Rogers, Lindsay Gordon, Erin Kennedy, Beverly Belle, Jessica McCorkle-Doomy, Jonathan Adams, Ramon Lopez, Juris Janavs, Frederic Rahbari-Oskoui, Arlene Chapman, Allen Dollar, Olubunmi Williams, Yoosun Han, William Haley, Peter Fitzpatrick, Joseph Blackshear, Brian Shapiro, Anna Harrell, Arta Palaj, Katelyn Henderson, Ashley Johnson, Heath Gonzalez, Jermaine Robinson, Leonardo Tamariz, Jennifer Denizard, Rody Barakat, Dhurga Krishnamoorthy, Frank Greenway, Ron Monce, Timothy Church, Chelsea Hendrick, Aimee Yoches, Leighanne Sones, Markee Baltazar, Priscilla Pemu, Connie Jones, Derrick Akpalu, Gordon Chelune, Jeffrey Childs, Lisa Gren, Anne Randall, Laura Dember, Denise Soares, Jerry Yee, Kausik Umanath, Naima Ogletree, Schawana Thaxton, Karen Campana, Dayna Sheldon, Krista MacArthur, J. Brent Muhlestein, Nathan Allred, Brian Clements, Ritesh Dhar, Kent Meredith, Viet Le, Edward Miner, James Orford, Erik R. Riessen, Becca Ballantyne, Ben Chisum, Kevin Johnson, Dixie Peeler, Glenn Chertow, Manju Tamura, Tara Chang, Kevin Erickson, Jenny Shen, Randall S. Stafford, Gregory Zaharchuk, Margareth Del Cid, Michelle Dentinger, Jennifer Sabino, Rukmani Sahay, Ekaterina Telminova, Daniel E. Weiner, Mark Sarnak, Lily Chan, Amanda Civiletto, Alyson Heath, Amy Kantor, Priyanka Jain, Bethany Kirkpatrick, Andrew Well, Barry Yuen, Michel Chonchol, Beverly Farmer, Heather Farmer, Carol Greenwald, Mikaela Malaczewski, James Lash, Anna Porter, Ana Ricardo, Robert T. Rosman, Janet Cohan, Nieves Lopez Barrera, Daniel Meslar, Patricia Meslar, Margaret Conroy, Mark Unruh, Rachel Hess, Manisha Jhamb, Holly Thomas, Pam Fazio, Elle Klixbull, Melissa Komlos-Weimer, LeeAnne Mandich, Tina Vita, Robert Toto, Peter Van Buren, Julia Inrig, Martha Cruz, Tammy Lightfoot, Nancy Wang, Lori Webster, Kalani Raphael, Barry Stults, Tahir Zaman, Debra Simmons, Tooran Lavasani, Rebecca Filipowicz, Guo Wei, Gracie Mary Miller, Jenice Harerra, Jeff Christensen, Ajay Giri, Xiaorui Chen, Natalie Anderton, Arianna Jensen, Julia Lewis, Anna Burgner, Jamie P. Dwyer, Gerald Schulman, Terri Herrud, Ewanda Leavell, Tiffany McCray, Edwina McNeil-Simaan, Munmun Poudel, Malia Reed, Mohammed Sika, Delia Woods, Janice L. Zirkenbach, Dominic S. Raj, Scott Cohen, Samir Patel, Manuel Velasquez, Roshni S. Bastian, Maria Wing, Akshay Roy-Chaudhury, Thomas Depner, Lorien Dalyrymple, George Kaysen, Susan Anderson, John Nord, Joachim H. Ix, Leonard Goldenstein, Cynthia M. Miracle, Nketi Forbang, Maja Mircic, Brenda Thomas, Tiffany Tran, Anjay Rastogi, Mihae Kim, Mohamad Rashid, Bianca Lizarraga, Amy Hocza, Kristine Sarmosyan, Jason Norris, Tushar Sharma, Amanda Chioy, Eric Bernard, Eleanore Cabrera, Christina Lopez, Susana Nunez, Joseph Riad, Suzanne Schweitzer, Siran Sirop, Sarah Thomas, Lauren Wada, Holly Kramer, Vinod Bansal, Corliss E. Taylor, Mark S. Segal, Karen L. Hall, Amir Kazory, Lesa Gilbert, Linda Owens, Danielle Poulton, Elaine Whidden, Jocelyn Wiggins, Caroline Blaum, Linda Nyquist, Lillian Min, Tanya Gure, Ruth Lewis, Jennifer Mawby, Eileen Robinson, Cora E. Lewis, Virginia Bradley, David Calhoun, Stephen Glasser, Kim Jenkins, Tom Ramsey, Nauman Qureshi, Karen Ferguson, Sumrah Haider, Mandy James, Christy Jones, Kim Renfroe, April Seay, Carrie Weigart, Denyse Thornley-Brown, Dana Rizik, Bari Cotton, Meredith Fitz-Gerald, Tiffany Grimes, Carolyn Johnson, Sara Kennedy, Chanel Mason, Lesa Rosato-Burson, Robin Willingham, Eric Judd, Tonya Breaux-Shropshire, Felice Cook, Julia Medina, Lama Ghazi, Hemal Bhatt, James Lewis, Roman Brantley, John Brouilette, Jeffrey Glaze, Stephanie Hall, Nancy Hiott, David Tharpe, Spencer Boddy, Catherine Mack, Catherine Womack, Keiko Asao, Beate Griffin, Carol Hendrix, Karen Johnson, Lisa Jones, Chelsea Towers, Henry Punzi, Kathy Cassidy, Kristin Schumacher, Carmen Irizarry, Ilma Colon, Pedro Colon-Ortiz, Pedro J. Colón-Hernández, Orlando J. Carrasquillo-Navarro, Merari Carrasquillo, Nivea Vazquez, Miguel Sosa-Padilla, Alex Cintron-Pinero, Mayra Ayala, Olga Pacheco, Catalina Rivera, Irma Sotomayor-Gonzalez, Jamie Claudio, Jose Lazaro, Migdalia Arce, Lourdes Heres, Alba Perez, Jose Tavarez-Valle, Ferlinda Arocho, Mercedes Torres, Melvaliz Vazquez, Gerard P. Aurigemma, Rebecca Takis-Smith, Julia Andrieni, Noelle Bodkin, Kiran Chaudhary, Paula Hu, John Kostis, Nora Cosgrove, Denise Bankowski, Monica Boleyn, Laurie Casazza, Victoria Giresi, Tosha Patel, Erin Squindo, Yan Wu, Zeb Henson, Marion Wofford, Jessica Lowery, Deborah Minor, Kimberley Harkins, Alexander Auchus, Michael Flessner, Cathy Adair, Jordan Asher, Debbie Loope, Rita Cobb, Reiner Venegas, Thomas Bigger, Natalie Bello, Shunichi Homma, Daniel Donovan, Carlos Lopez-Jimenez, Amilcar Tirado, Asqual Getaneh, Rocky Tang, Sabrina Durant, Mathew Maurer, Sergio Teruya, Stephen Helmke, Julissa Alvarez, Ruth Campbell, Roberto Pisoni, Rachel Sturdivant, Deborah Brooks, Caroline Counts, Vickie Hunt, Lori Spillers, Donald Brautigam, Timothy Kitchen, Timothy Gorman, Jessica Sayers, Sarah Button, June Chiarot, Rosemary Fischer, Melissa Lyon, Maria Resnick, Nicole Hodges, Jennifer Ferreira, William Cushman, Barry Wall, Linda Nichols, Robert Burns, Jennifer Martindale-Adams, Dan Berlowitz, Elizabeth Clark, Sandy Walsh, Terry Geraci, Carol Huff, Linda Shaw, Karen Servilla, Darlene Vigil, Terry Barrett, Mary Ellen Sweeney, Rebecca Johnson, Susan McConnell, Khadijeh Shahid Salles, Francoise Watson, Cheryl Schenk, Laura Whittington, Maxine Maher, Jonathan Williams, Stephen Swartz, Paul Conlin, George Alexis, Rebecca Lamkin, Patti Underwood, Helen Gomes, Clive Rosendorff, Stephen Atlas, Saadat Khan, Waddy Gonzalez, Samih Barcham, Lawrence Kwon, Matar Matar, Anwar Adhami, Jan Basile, Joseph John, Deborah Ham, Hadi Baig, Mohammed Saklayen, Jason Yap, Helen Neff, Carol Miller, Ling Zheng-Phelan, Saib Gappy, Shiva Rau, Arathi Raman, Vicki Berchou, Elizabeth Jones, Erin Olgren, Cynthia Marbury, Michael Yudd, Sithiporn Sastrasinh, Jennine Michaud, Jessica Fiore, Marianne Kutza, Ronald Shorr, Rattana Mount, Helen Dunn, Susan Stinson, Jessica Hunter, Addison Taylor, Jeffery Bates, Catherine Anderson, Kent Kirchner, Jodi Stubbs, Ardell Hinton, Anita Spencer, Santosh Sharma, Thomas Wiegmann, Smita Mehta, Michelle Krause, Kate Dishongh, Richard Childress, Geeta Gyamlani, Atossa Niakan, Cathy Thompson, Janelle Moody, Carolyn Gresham, Jeffrey Whittle, Gary Barnas, Dawn Wolfgram, Heidi Cortese, Jonette Johnson, Christianne Roumie, Adriana Hung, Jennifer Wharton, Kurt Niesner, Lois Katz, Elizabeth Richardson, George Brock, Joanne Holland, Troy Dixon, Athena Zias, Christine Spiller, Penelope Baker, James Felicetta, Shakaib Rehman, Kelli Bingham, Suzanne Watnick, David Cohen, Jessica Weiss, Tera Johnston, Stephen Giddings, Hala Yamout, Andrew Klein, Caroline Rowe, Kristin Vargo, Kristi Waidmann, Vasilios Papademetriou, Jean Pierre Elkhoury, Barbara Gregory, Susan Amodeo, Mary Bloom, Dalia Goldfarb-Waysman, Richard Treger, Mehran Kashefi, Christina Huang, Karen Knibloe, Areef Ishani, Yelena Slinin, Christine Olney, Jacqueline Rust, Paolo Fanti, Christopher Dyer, Shweta Bansal, Monica Dunnam, Lih-Lan Hu, and Perla Zarate-Abbott

Subjects
Male, medicine.medical_specialty, Renal function, Perfusion scanning, Blood Pressure, Article, chemistry.chemical_compound, Internal medicine, medicine, Humans, Cerebral perfusion pressure, Renal Insufficiency, Chronic, Antihypertensive Agents, Aged, Creatinine, business.industry, medicine.disease, Perfusion, Blood pressure, chemistry, Cerebral blood flow, Nephrology, Cerebrovascular Circulation, Hypertension, Albuminuria, Cardiology, Female, medicine.symptom, business, Kidney disease, Glomerular Filtration Rate
Abstract

RATIONALE AND OBJECTIVE: The safety of intensive blood pressure (BP) targets is controversial for persons with chronic kidney disease (CKD). We studied the effects of hypertension treatment on cerebral perfusion and structure in those with and without CKD. STUDY DESIGN: Neuroimaging substudy of a randomized trial. SETTING & PARTICIPANTS: A subset of participants in the Systolic Blood Pressure Intervention Trial who underwent brain MRI studies. Presence of baseline CKD was assessed by estimated glomerular filtration rate (eGFR) and urine albumin to creatinine ratio (UACR). INTERVENTION: Participants were randomly assigned to intensive (systolic BP 30 mg/g (N=151), the effects of intensive versus standard BP treatment on change in global cerebral blood flow, WMLs and total brain volume were 1.91 ml/100g/min (95% CI −3.01, 6.82), 0.003 cm(3) (asinh transformed, 95% CI −0.13, 0.13), and −7.0 cm(3) (95% CI −13.3, −0.3), respectively. The overall treatment effects on cerebral blood flow and total brain volume were not modified by baseline eGFR or UACR; however the effect on WMLs was attenuated in participants with albuminuria (interaction p-value 0.04). LIMITATIONS: Measurement variability due to multi-site design. CONCLUSIONS: Among hypertensive adults with primarily early kidney disease, intensive versus standard blood pressure treatment did not appear to have a detrimental effect on brain perfusion or structure. The findings support the safety of intensive blood pressure treatment targets on brain health in persons with early kidney disease. FUNDING: The Systolic Blood Pressure Intervention Trial was funded by the National Institutes of Health (including the National Heart, Lung, and Blood Institute, the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute on Aging, and the National Institute of Neurological Disorders and Stroke), and this substudy was funded by the National Institutes of Diabetes and Digestive and Kidney Diseases. TRIAL REGISTRATION: SPRINT was registered at ClinicalTrials.gov with the study number NCT01206062.

Published
2021

8. FAQ

Author

Gregory Simon, Gloria Coronado, Lynn DeBar, Laura Dember, Beverly Green, Susan Huang, Jeffrey Jarvik, Vincent Mor, Joakim Ramsberg, Edward Septimus, Miguel Vazquez, William Vollmer, Douglas Zatzick, Adrian Hernandez, and Richard Platt

Published
2019

9. Additional Resources

Author

Gregory Simon, Gloria Coronado, Lynn DeBar, Laura Dember, Beverly Green, Susan Huang, Jeffrey Jarvik, Vincent Mor, Joakim Ramsberg, Edward Septimus, Miguel Vazquez, William Vollmer, Douglas Zatzick, Adrian Hernandez, and Richard Platt

Published
2019

10. Implementing core outcomes in kidney disease: report of the Standardized Outcomes in Nephrology (SONG) implementation workshop

Author

Allison Tong, Braden Manns, Angela Yee Moon Wang, Brenda Hemmelgarn, David C. Wheeler, John Gill, Peter Tugwell, Robert Pecoits-Filho, Sally Crowe, Tess Harris, Wim Van Biesen, Wolfgang C. Winkelmayer, Adeera Levin, Aliza Thompson, Vlado Perkovic, Angela Ju, Talia Gutman, Amelie Bernier-Jean, Andrea K. Viecelli, Emma O’Lone, Jenny Shen, Michelle A. Josephson, Yeoungjee Cho, David W. Johnson, Bénédicte Sautenet, Marcello Tonelli, Jonathan C. Craig, Jonathan Craig, Angela Wang, David Wheeler, Roberto Pecoits-Filho, Wim van Biesen, Wolfgang Winkelmayer, Aditi Sinha, Albert Ong, Alexis Denny, Allison Dart, Allison Eddy, Amy Kelly, Andrea Viecelli, Andrew Davenport, Andrew Narva, Ankit Sharma, Anthony Warrens, Arlene Chapman, Armando Teixeira-Pinto, Ayano Kelly, Barbara Murphy, Benedicte Sautenet, Benita Padilla, Bernard Canaud, Brian Pullin, Brigitte Schiller, Bruce Robinson, Camilla Hanson, Carmel Hawley, Charlotte Logeman, Charmaine Lok, Christoph Wanner, Chuck Herzog, Claudia Rutherford, Curie Ahn, Daniel Sumpton, David Rosenbloom, David Harris, David Baron, David Johnson, David White, Debbie Gipson, Denis Fouque, Denise Eilers, Detlef Bockenhauer, Donal O'Donoghue, Dongping Chen, Dyke Dunning, Edwina Brown, Elena Bavlovlenkov, Elinor Mannon, Emilo Poggio, Emma O'Lone, Eric Chemla, Fabienne Dobbels, Faiez Zannad, Fergus Caskey, Francesca Tentori, Frank Hurst, Franz Schaefer, Germaine Wong, Gillian Brunier, Giovanni Strippoli, Gopala Rangan, Greg Knoll, Gregorio Obrador, Harold Feldman, Helen Coolican, Hui-Kim Yap, Jaap Groothoff, James Sloand, Jane Tan, Jayme Locke, Jeffrey Perl, Jeremy Chapman, Jie Dong, Jolanta Malyszko, Jonathan Fox, Juan Dapueto, Juliana Tze-Wah Kao, Kai Ming Chow, Karine Manera, Karolis Azukaitis, Kevan Polkinghorne, Kevin Fowler, Kim Linh Van, Klemens Budde, Krista Lentine, Krister Cromm, Lai-Seong Hooi, Laura James, Laura Dember, Li Zuo, Lionel Rostaing, Liz Lightstone, Lorna Marson, Lorraine Hamiwka, Mahesh Krishnan, Marinella Ruospo, Mark Unruh, Martin Wilkie, Martin Howell, Mary Amanda Dew, Meg Jardine, Melissa West, Michael Zappitelli, Michael Germain, Michelle Josephson, Mike Rocco, Myra Kleinpeter, Nichole Jefferson, Nick Webb, Nicole Evangelidis, Nieltje Gedney, Pam Duquette, Peter Kerr, Patrick Rossignol, Peter Reese, Peter J. Blankestijn, Prabir Roy-Chaudhury, Priti Patel, Quinetta Taylor, Rachel Perlman, Rainer Oberbauer, Rajnish Mehrotra, Raymond Vanholder, Richard Fluck, Richard McGee, Rob Quinn, Robert Lee, Ron Gansevoort, Ronald Perrone, Ronke Apata, Roslyn Mannon, Sajeda Youssouf, Sara Davison, Sarah Bernays, Sarala Naiker, Sharon Teo, Sheila Jowsey-Gregoire, Simon Carter, Stefano Stuard, Stephen Alexander, Stephen McDonald, Steve Chadban, Stuart Goldstein, Susan Furth, Susan Samuel, Tariq Shafi, Tazeen Jafar, Thomas Hiemstra, Tim Pruett, Timmy Lee, Tushar Vachharajani, Vanita Jassal, Vera Krane, Vicente Torres, Vivekanand Jha, Will Herrington, Yoonkyu Oh, York Pei, Zeeshan Butt, MethodS in Patients-centered outcomes and HEalth ResEarch (SPHERE), Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques, Université de Nantes (UN)-Université de Nantes (UN), Paediatric Nephrology, APH - Methodology, AGEM - Inborn errors of metabolism, APH - Quality of Care, ARD - Amsterdam Reproduction and Development, and Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques

Subjects
Research design, HEMODIALYSIS, Comparative Effectiveness Research, Kidney Disease, kidney disease, [SDV]Life Sciences [q-bio], 030232 urology & nephrology, Disease, patient-centered care, outcomes, law.invention, 0302 clinical medicine, Randomized controlled trial, law, 030212 general & internal medicine, Renal Insufficiency, Chronic, implementation, Randomized Controlled Trials as Topic, SETS, trials, core outcome sets, Urology & Nephrology, 3. Good health, Treatment Outcome, CONSENSUS WORKSHOP, Nephrology, Research Design, General partnership, HEALTH, Life Sciences & Biomedicine, CLINICAL-TRIALS, PRIORITIES, medicine.medical_specialty, DOMAINS, Consensus, Endpoint Determination, education, Clinical Trials and Supportive Activities, Clinical Sciences, Renal and urogenital, SONG Implementation Workshop Investigators, PATIENT, Article, CONSISTENCY, 03 medical and health sciences, Quality of life (healthcare), Stakeholder Participation, Clinical Research, medicine, Humans, Renal Insufficiency, Chronic, Science & Technology, TRANSPLANTATION, business.industry, 1103 Clinical Sciences, Usability, Guideline, medicine.disease, Good Health and Well Being, Family medicine, Generic health relevance, business, Kidney disease
Abstract

There are an estimated 14,000 randomized trials published in chronic kidney disease. The most frequently reported outcomes are biochemical endpoints, rather than clinical and patient-reported outcomes including cardiovascular disease, mortality, and quality of life. While many trials have focused on optimizing kidney health, the heterogeneity and uncertain relevance of outcomes reported across trials may limit their policy and practice impact. The international Standardized Outcomes in Nephrology (SONG) Initiative was formed to identify core outcomes that are critically important to patients and health professionals, to be reported consistently across trials. We convened a SONG Implementation Workshop to discuss the implementation of core outcomes. Eighty-two patients/caregivers and health professionals participated in plenary and breakout discussions. In this report, we summarize the findings of the workshop in two main themes: socializing the concept of core outcomes, and demonstrating feasibility and usability. We outline implementation strategies and pathways to be established through partnership with stakeholders, which may bolster acceptance and reporting of core outcomes in trials, and encourage their use by end-users such as guideline producers and policymakers to help improve patient-important outcomes. ispartof: pages:1053-1068 ispartof: Kidney Int vol:94 issue:6 pages:1053-1068 ispartof: location:United States status: published

Published
2018

11. Moving Forward

Author

Gregory Simon, Gloria Coronado, Lynn DeBar, Laura Dember, Beverly Green, Susan Huang, Jeffrey Jarvik, Vincent Mor, Joakim Ramsberg, Edward Septimus, Miguel Vazquez, William Vollmer, Douglas Zatzick, Adrian Hernandez, and Richard Platt

Published
2017

12. Introduction

Author

Gregory Simon, Gloria Coronado, Lynn DeBar, Laura Dember, Beverly Green, Susan Huang, Jeffrey Jarvik, Vincent Mor, Joakim Ramsberg, Edward Septimus, Miguel Vazquez, William Vollmer, Douglas Zatzick, Adrian Hernandez, and Richard Platt

Published
2017

13. Abstract 625: Adipose-Associated Mediators Correlate with Anatomic and Physiologic Adaptations Following Fistula Placement: The Hemodialysis Fistula Maturation (HFM) Study

Author

Christopher S Kuppler, Gaurav Sharma, Yong He, Ming Tao, Laura Dember, C. Keith Ozaki, and Scott A Berceli

Subjects
Cardiology and Cardiovascular Medicine, psychological phenomena and processes
Abstract

Introduction: Perivascular inflammation stands as an important regulator of vascular remodeling. We hypothesize that the phenotype of adipose tissue adjacent to a hemodialysis arteriovenous fistula (AVF) modulates the anatomy and physiology of maturation. Methods: During AVF creation, adipose tissue adjacent to the vein was collected from 112 participants in the NIDDK HFM Study, and 9 adipose-associated mediator protein levels were measured. AVF duplex ultrasound was performed post-operatively at Day 1, and Weeks 2 and 6, and prior to 1 st cannulation (Week 10-22) to define the changes in diameter and flow. Associations between biomarker levels and fistula remodeling were evaluated using mixed effects regression analyses. Results: Fractional changes in vein diameter decrease with increasing IL-6 and MCP-1 levels; changes in AVF flow decrease with increasing leptin ( A ). IL-6 demonstrated a statistically significant relationship with vein adaptations in the early time frame (1D-2W), but not in the later stages of remodeling ( B ). Additional interaction effects between concentration and diameter/flow changes were identified, with elevated inflammatory biomarker levels correlated with reduced early and peri-anastomotic changes in vein diameter and flow ( C ). Conclusions: Changes in AVF diameter and flow are associated with baseline local adipose phenotype. Impaired vein dilation and reduced capacity for flow augmentation appears related to enhanced inflammation, particularly at early times and in the peri-anastomotic region.

Published
2015

14. Symptom Monitoring in Hemodialysis (SMaRRT-HD)

Author

University of North Carolina, Chapel Hill, Duke University, University of New Mexico, Fresenius Medical Care North America, Patient-Centered Outcomes Research Institute, and Laura Dember, MD, Professor of Medicine and Epidemiology

Published
2024

16. Differential effects of dopamine agonists on acoustically and electrically elicited startle responses: comparison to effects of strychnine

Author

James V. Cassella, T. Patrick Harty, Randall L. Commissaris, Syngil Yang, Laura Dember, and Michael Davis

Subjects
Central Nervous System, Male, medicine.medical_specialty, Startle response, Reflex, Startle, Dextroamphetamine, Apomorphine, behavioral disciplines and activities, Cochlear nucleus, chemistry.chemical_compound, Dopamine, Internal medicine, Pons, Neural Pathways, otorhinolaryngologic diseases, medicine, Animals, Molecular Biology, Cochlear Nerve, Electroshock, medicine.diagnostic_test, General Neuroscience, Reflex arc, Rats, Inbred Strains, Strychnine, Rats, Endocrinology, medicine.anatomical_structure, chemistry, Acoustic Stimulation, Spinal Cord, Acoustic Startle Reflex, sense organs, Neurology (clinical), Serotonin, Neuroscience, psychological phenomena and processes, Developmental Biology, medicine.drug
Abstract

This study sought to determine where drugs that are known to alter sensorimotor reactivity measured with the acoustic startle reflex ultimately act within the acoustic startle pathway. To do this, startle was elicited either acoustically or electrically within various nuclei believed to comprise the acoustic startle pathway. Direct infusion of serotonin into the subarachnoid space of the lumbar spinal cord increased acoustic startle and startle elicited electrically through the ventral cochlear nucleus (VCN) to a comparable degree. Subconvulsant doses of strychnine increased startle elicited acoustically or electrically through either the VCN or the nucleus reticularis pontis caudalis (RPC), pointing to spinal locus of action of strychnine after systemic administration. In marked contrast, the dopamine agonists d-amphetamine and apomorphine consistently increased acoustic startle but actually depressed startle elicited electrically through the VCN or the RPC. These later results suggest that dopamine agonists increase sensorimotor reactivity measured with acoustic startle by acting on sensory rather than motor parts of the reflex arc.

Published
1986

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