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2. Identification of Novel Biomarkers and Pathways for Coronary Artery Calcification in Nondiabetic Patients on Hemodialysis Using Metabolomic Profiling.

Author

Chen, Wei, Fitzpatrick, Jessica, Sozio, Stephen M, Jaar, Bernard G, Estrella, Michelle M, Riascos-Bernal, Dario F, Wu, Tong Tong, Qiu, Yunping, Kurland, Irwin J, Dubin, Ruth F, Chen, Yabing, Parekh, Rulan S, Bushinsky, David A, and Sibinga, Nicholas ES

Subjects
Humans, Renal Dialysis, Case-Control Studies, Coronary Artery Disease, Metabolomics, Vascular Calcification, Biomarkers, Diabetes, Clinical Research, Heart Disease - Coronary Heart Disease, Heart Disease, Prevention, Cardiovascular, 4.1 Discovery and preclinical testing of markers and technologies, Detection, screening and diagnosis, mineral metabolism, arginine and proline metabolism, arterial calcification, bile acid, coronary artery disease, dialysis, metabolomics
Abstract

BackgroundA better understanding of the pathophysiology involving coronary artery calcification (CAC) in patients on hemodialysis (HD) will help to develop new therapies. We sought to identify the differences in metabolomics profiles between patients on HD with and without CAC.MethodsIn this case-control study, nested within a cohort of 568 incident patients on HD, the cases were patients without diabetes with a CAC score >100 (n=51), and controls were patients without diabetes with a CAC score of zero (n=48). We measured 452 serum metabolites in each participant. Metabolites and pathway scores were compared using Mann-Whitney U tests, partial least squares-discriminant analyses, and pathway enrichment analyses.ResultsCompared with controls, cases were older (64±13 versus 42±12 years) and were less likely to be Black (51% versus 94%). We identified three metabolites in bile-acid synthesis (chenodeoxycholic, deoxycholic, and glycolithocholic acids) and one pathway (arginine/proline metabolism). After adjusting for demographics, higher levels of chenodeoxycholic, deoxycholic, and glycolithocholic acids were associated with higher odds of having CAC; comparing the third with the first tertile of each bile acid, the OR was 6.34 (95% CI, 1.12 to 36.06), 6.73 (95% CI, 1.20 to 37.82), and 8.53 (95% CI, 1.50 to 48.49), respectively. These associations were no longer significant after further adjustment for coronary artery disease and medication use. Per 1 unit higher in the first principal component score, arginine/proline metabolism was associated with CAC after adjusting for demographics (OR, 1.83; 95% CI, 1.06 to 3.15), and the association remained significant with additional adjustments for statin use (OR, 1.84; 95% CI, 1.04 to 3.27).ConclusionsAmong patients on HD without diabetes mellitus, chenodeoxycholic, deoxycholic, and glycolithocholic acids may be potential biomarkers for CAC, and arginine/proline metabolism is a plausible mechanism to study for CAC. These findings need to be confirmed in future studies.

Published
2021

5. Diabetes Mellitus Modifies the Associations of Serum Magnesium Concentration With Arterial Calcification and Stiffness in Incident Hemodialysis Patients

Author

Chen, Wei, Fitzpatrick, Jessica, Monroy-Trujillo, Jose M, Sozio, Stephen M, Jaar, Bernard G, Estrella, Michelle M, Wu, Tong Tong, Melamed, Michal L, Parekh, Rulan S, and Bushinsky, David A

Subjects
Bioengineering, Prevention, Kidney Disease, Diabetes, Assistive Technology, Cardiovascular, Clinical Research, Metabolic and endocrine, arterial calcification, arterial stiffness, diabetes mellitus, magnesium, mineral metabolism
Abstract

IntroductionMagnesium (Mg) may protect against arterial calcification. We tested the hypotheses that a higher serum Mg concentration is associated with less arterial calcification and stiffness in patients on hemodialysis (HD) and that these associations are modified by diabetes mellitus.MethodsWe performed cross-sectional analyses of 367 incident HD patients from the Predictors of Arrhythmic and Cardiovascular Risk in End Stage Renal Disease (PACE) cohort. Measures of arterial calcification and stiffness included coronary arterial calcification (CAC) and thoracic aortic calcification (TAC) scores, ankle brachial index (ABI; high ABI: >1.4 or incompressible vessels), pulse wave velocity (PWV), and pulse pressure.ResultsMean Mg was 1.8 ± 0.2 mEq/l and 58% had diabetes. Among nondiabetic individuals, per 0.1 mEq/l higher Mg, non-zero CAC score was lower (% difference: -15.4%; 95% confidence interval [CI]: -28% to -0.55%; P = 0.03), the odds of having TAC score >0 and the odds of having high ABI were lower (odds ratio [OR]: 0.66; 95% CI 0.47-0.93; P = 0.02, and 0.23; 95% CI: 0.06-0.83, P = 0.03, respectively) while adjusting for demographics, comorbidities, markers of mineral metabolism, and dialysis clearance. Among diabetic individuals, per 0.1 mEq/l higher Mg, the odds of having TAC score >0 was higher (OR: 1.57; 95% CI: 1.09-2.26; P = 0.02). Mg was not associated with CAC or high ABI among diabetic individuals. Mg was not associated with PWV or pulse pressure regardless of diabetes status.ConclusionDiabetes modified the associations of serum Mg with arterial calcification and stiffness in incident HD patients. Higher Mg was associated with less arterial calcification and less peripheral arterial stiffness among nondiabetic individuals, but Mg was only associated with TAC among diabetic individuals with higher Mg being associated with higher likelihood of having TAC score >0.

Published
2019

9. Relationship of acid-base status with arterial stiffness in community-living elders: the Health ABC Study.

Author

Chen, Wei, Newman, Anne B, Fried, Linda F, Rifkin, Dena E, Shlipak, Michael G, Sarnak, Mark J, Katz, Ronit, Madero, Magdalena, Raphael, Kalani L, Bushinsky, David A, and Ix, Joachim H

Subjects
Kidney Disease, Prevention, Renal and urogenital, Acid-Base Equilibrium, Activities of Daily Living, Aged, Ankle Brachial Index, Cross-Sectional Studies, Female, Glomerular Filtration Rate, Humans, Male, Prospective Studies, Renal Insufficiency, Chronic, Vascular Stiffness, acidosis, arterial calcification, arterial stiffness, metabolic acidosis, serum bicarbonate, Clinical Sciences, Urology & Nephrology
Abstract

Background:Animal studies suggest that acidosis protects against arterial calcification, which contributes to arterial stiffness. The goal of this study was to investigate the associations of serum bicarbonate and pH with arterial stiffness in community-living older adults. Methods:We performed cross-sectional analyses among 1698 well-functioning participants 70-79 years of age. Bicarbonate and pH were measured by arterialized venous blood gas at the point of care. Bicarbonate was categorized into low (7.40-7.42 and >7.42. Arterial stiffness was evaluated by pulse wave velocity (PWV) and high ankle-brachial index (ABI; >1.3/incompressible). We used linear and logistic regression to evaluate the association of bicarbonate and AVpH with PWV and high ABI, respectively. Results:The mean age was 76 years and 15% had an estimated glomerular filtration rate (eGFR)

Published
2018

15. VALOR-CKD: A Multicenter, Randomized, Double-Blind Placebo-Controlled Trial Evaluating Veverimer in Slowing Progression of Chronic Kidney Disease in Patients with Metabolic Acidosis

Author

Tangri, Navdeep, primary, Mathur, Vandana S., additional, Bushinsky, David A., additional, Klaerner, Gerrit, additional, Li, Elizabeth, additional, Parsell, Dawn, additional, Stasiv, Yuri, additional, Walker, Michael, additional, Wesson, Donald E., additional, Wheeler, David C., additional, Perkovic, Vlado, additional, and Inker, Lesley A., additional

Published
2024
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18. List of Contributors

Author

Abramovitz, Blaise, primary, Adu, Dwomoa, additional, Afshinnia, Farsad, additional, Agarwal, Anupam, additional, Andrews, Sarah C., additional, Appel, Gerald, additional, Bailey, James L., additional, Bakris, George L., additional, Bauer, Carolyn A., additional, Baxi, Pravir V., additional, Berns, Jeffrey S., additional, Birks, Peter, additional, Bomback, Andrew, additional, Bose, Anirban, additional, Brosius, Frank C., additional, Brown, Lee K., additional, Bushinsky, David A., additional, Busse, Laurence W., additional, Campbell, Ruth C., additional, Canney, Mark, additional, Cathro, Helen, additional, Chávez-Iñiguez, Jonathan, additional, Chawla, Lakhmir S., additional, Chen, Sheldon, additional, Chertow, Glenn M., additional, Chew, Emily Y., additional, Chonchol, Michel, additional, Clegg, Deborah J., additional, Clive, David M., additional, Clive, Pia H., additional, Cohen, Scott D., additional, Collins, Ashte' K., additional, Cooper, James E., additional, Correa-Rotter, Ricardo, additional, Cukor, Daniel, additional, Dalal, Monica, additional, Davenport, Andrew, additional, Davis, Scott, additional, Davison, Sara N., additional, Delanaye, Pierre, additional, de Zeeuw, Dick, additional, Dobre, Mirela A., additional, Drawz, Paul, additional, Ebert, Natalie, additional, Eggers, Paul, additional, Ferrè, Silvia, additional, Freedman, Barry I., additional, Furth, Susan L., additional, Gao, Bixia, additional, García-García, Guillermo, additional, Gashti, Casey N., additional, Germino, Gregory G., additional, Goldsmith, David, additional, Golestaneh, Ladan, additional, Goligorsky, Michael S., additional, Greenberg, Arthur, additional, Gregg, L. Parker, additional, Guay-Woodford, Lisa M., additional, Hamm, Lee, additional, Hart, Allyson, additional, Haselby, Danielle, additional, Hedayati, S. Susan, additional, Heerspink, Hiddo J.L., additional, Herzog, Charles A., additional, Hostetter, Thomas H., additional, House, Andrew A., additional, Hruska, Keith A., additional, Ishani, Areef, additional, Isom, Robert T., additional, James, Matthew T., additional, Jhaveri, Kenar D., additional, Johansen, Kirsten, additional, Johnson, Richard J., additional, Kang, Duk-Hee, additional, Kanno, Hiroko, additional, Kanno, Yoshihiko, additional, Karambelkar, Amrita D., additional, Karet Frankl, Fiona E., additional, Khoury, Charbel C., additional, Kimmel, Paul L., additional, Kopp, Jeffrey B., additional, Korbet, Stephen M., additional, Kruzel-Davila, Etty, additional, Kummer, Andrew, additional, LaFave, Laura, additional, Lakkis, Jay I., additional, Lerman, Lilach O., additional, Levin, Adeera, additional, Lew, Susie Q., additional, Luyckx, Valerie A., additional, Mattoo, Tej K., additional, Maynard, Sharon E., additional, McCullough, Peter A., additional, Mehrotra, Rajnish, additional, Meyer, Timothy W., additional, Mitch, William E., additional, Moe, Orson W., additional, Mohandes, Samer, additional, Moss, Alvin H., additional, Moxey-Mims, Marva, additional, Murugapandian, Sangeetha, additional, Nath, Karl A., additional, Neugarten, Joel, additional, Neyra, Javier A., additional, Nissenson, Allen R., additional, Nobakht, Ehsan, additional, Nolin, Thomas D., additional, Norris, Keith C., additional, Norton, Jenna M., additional, Nowak, Kristen L., additional, Ojo, Akinlolu O., additional, Pahl, Madeleine V., additional, Paller, Mark S., additional, Palmer, Biff F., additional, Palmer, Nicholette D., additional, Patel, Samir S., additional, Pecoits-Filho, Roberto, additional, Peitzman, Steven J., additional, Peixoto, Aldo J., additional, Pham, Phuong-Thu T., additional, Pham, Phuong-Chi T., additional, Piraino, Beth, additional, Pisoni, Roberto, additional, Rabelink, Ton, additional, Radhakrishnan, Jai, additional, Rahman, Mahboob, additional, Raj, Dominic S., additional, Ramírez-Sandoval, Juan C., additional, Rangaswami, Janani, additional, Reckelhoff, Jane F., additional, Regunathan-Shenk, Renu, additional, Reule, Scott, additional, Ronco, Claudio, additional, Rosenberg, Mark E., additional, Rosner, Mitchell H., additional, Rovin, Brad, additional, Roy-Chaudhury, Prabir, additional, Ruebner, Rebecca, additional, Rule, Andrew D., additional, Sands, Jeff M., additional, Schlanger, Lynn E., additional, Schrauben, Sarah J., additional, Seliger, Stephen, additional, Shah, Maulin, additional, Sterns, Richard H., additional, Stites, Erik, additional, Sugatani, Toshifumi, additional, Textor, Stephen C., additional, Thadhani, Ravi, additional, Thajudeen, Bijin, additional, Thakar, Surabhi, additional, Thomas, George, additional, Townsend, Raymond R., additional, Turner, Jeffrey, additional, Unruh, Mark L., additional, Urquhart, Bradley L., additional, Vassalotti, Joseph A., additional, Vaziri, Nosratola D., additional, Velasquez, Manuel T., additional, Ver Halen, Nisha, additional, Waddy, Salina P., additional, Wang, Jinwei, additional, Weber, Marc, additional, Weir, Matthew R., additional, White, Christine A., additional, Whittier, William L., additional, Williams, Matthew J., additional, Wiseman, Alexander C., additional, Wymer, David C., additional, Wymer, David T.G., additional, Yee, Jerry, additional, Zhang, Luxia, additional, Zhuang, Shougang, additional, and Ziyadeh, Fuad N., additional

Published
2020
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26. List of Contributors

Author

Ackert-Bicknell, Cheryl, primary, Agarwal, Sunita K., additional, Albagha, Omar M.E., additional, Allen, Robyn S., additional, Arnold, Andrew, additional, Bassett, J.H. Duncan, additional, Bateman, John F., additional, Bellido, Teresita, additional, Bonewald, Lynda, additional, Boudin, Eveline, additional, Bouxsein, Mary L., additional, Boyce, Brendan F., additional, Brewer, Niambi S., additional, Brewster, Stephanie J., additional, Briggs, Mike, additional, Brown, Edward M., additional, Brown, Matthew A., additional, Bushinsky, David A., additional, Cabral, Wayne A., additional, Collins, Michael T., additional, Convente, Michael R., additional, Costa-Guda, Jessica, additional, Deng, Hong-Wen, additional, Devuyst, Olivier, additional, Drezner, Marc K., additional, Duncan, Emma L., additional, Egbuna, Ogo I., additional, Eisman, John A., additional, Farber, Charles R., additional, Feldman, David, additional, Ferreira, Carlos R., additional, Gahl, William A., additional, Gorvin, Caroline M., additional, Grol, Matthew W., additional, Guo, Yan, additional, Guse, Kilian, additional, Hannan, Fadil M., additional, Hao, Ruo-Han, additional, Holm, Ingrid A., additional, Igarashi, Takashi, additional, Jacobsen, Christina, additional, Johannesdottir, Fjola, additional, Jüppner, Harald, additional, Kaplan, Frederick S., additional, Karsenty, Gerard, additional, Kovacs, Christopher S., additional, Kuiper, John J., additional, Lee, Brendan H., additional, Loots, Gabriela G., additional, Lories, Rik J., additional, Luyten, Frank P., additional, Malloy, Peter J., additional, Mannstadt, Michael, additional, Marini, Joan C., additional, John Martin, T., additional, Miller, Walter L., additional, Moe, Orson W., additional, Newey, Paul J., additional, Nguyen, Tuan V., additional, Okamoto, Kazuo, additional, Pajevic, Paola D., additional, Papasian, Christopher J., additional, Piret, Siân E., additional, Ralston, Stuart H., additional, Rivadeneira, Fernando, additional, Robey, Pamela G., additional, Rosen, Clifford J., additional, Ruan, Merry Z.C., additional, Scheinman, Steven J., additional, Schurman, Scott J., additional, Sebastian, Aimy, additional, Shen, Yiping, additional, Shore, Eileen M., additional, Silve, Caroline, additional, Sims, Natalie A., additional, Stanley, Alexandra K., additional, Stone, Adrianne, additional, Takayanagi, Hiroshi, additional, Thakker, Rajesh V., additional, Towler, O. Will, additional, Uitterlinden, André G., additional, Valdes, Ana M., additional, van der Eerden, Bram C.J., additional, Van Hul, Wim, additional, Wei, Jianwen, additional, Wein, Marc N., additional, Weinstein, Lee S., additional, Whyte, Michael P., additional, Williams, Graham R., additional, Xing, Lianping, additional, Yang, Tie-Lin, additional, Zankl, Andreas, additional, Ziegler, Shira G., additional, and Zuscik, Michael J., additional

Published
2018
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28. Metabolic diagnosis and medical prevention of calcium nephrolithiasis and its systemic manifestations: a consensus statement

Author

Gambaro, Giovanni, Croppi, Emanuele, Coe, Fredric, Lingeman, James, Moe, Orson, Worcester, Elen, Buchholz, Noor, Bushinsky, David, Curhan, Gary C., Ferraro, Pietro Manuel, Fuster, Daniel, Goldfarb, David S., Heilberg, Ita Pfeferman, Hess, Bernard, Lieske, John, Marangella, Martino, Milliner, Dawn, Preminger, Glen M., Reis Santos, Jose’ Manuel, Sakhaee, Khashayar, Sarica, Kemal, Siener, Roswitha, Strazzullo, Pasquale, Williams, James C., Bartoletti, R., Buchholz, N., Bushinsky, D., Capasso, G. B., Cicerello, E., Coe, F., Croppi, E., Cupisti, A., Curhan, G. C., Desai, J., Fabris, A., Ferraro, P. M., Fuster, D., Gambaro, G., Goldfarb, D. S., Heilberg, I. P., Hess, B., Jaeger, Ph., Kirkali, Z., Kok, D., Letavernier, E., Lieske, J., Lingeman, J., Marangella, M., Mazzaferro, S., Moe, O., Milliner, D., Nouvenne, A., Preminger, G. M., Prie, D., Reis Santos, J., Rendina, D., Sakhaee, K., Sarica, K., Siener, R., Soldati, L., Strazzullo, P., Tasca, A., Trinchieri, A., Vezzoli, G., Vitale, C., Wu, W., Williams, J. C., Worcester, E., and The Consensus Conference Group

Published
2016
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30. Design and population of the VALOR-CKD study: a multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of veverimer in slowing progression of chronic kidney disease in patients with metabolic acidosis

Author

Mathur, Vandana S, primary, Bushinsky, David A, additional, Inker, Lesley, additional, Klaerner, Gerrit, additional, Li, Elizabeth, additional, Parsell, Dawn, additional, Perkovic, Vlado, additional, Stasiv, Yuri, additional, Walker, Michael, additional, Wesson, Donald E, additional, Wheeler, David C, additional, and Tangri, Navdeep, additional

Published
2022
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32. Acidosis and Bone

Author

Bushinsky, David A., Burckhardt, Peter, editor, Dawson-Hughes, Bess, editor, and Weaver, Connie, editor

Published
2010
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34. Contributors

Author

Agarwal, Rajiv, primary, Aghemo, Alessio, additional, Al-Lawati, Ali, additional, Allon, Michael, additional, Andrews, Walter S., additional, Annunziato, Rachel A., additional, Araya, Carlos E., additional, Asif, Arif, additional, Ayoob, Rose M., additional, Baracco, Rossana, additional, Bargman, Joanne, additional, Beathard, Gerald A., additional, Bellasi, Antonio, additional, Bennett, William M., additional, Berns, Jeffrey S., additional, Bieber, Scott, additional, Block, Geoffrey A., additional, Boccardo, Paola, additional, Brookens, Andrew, additional, Brophy, Patrick D., additional, Brunelli, Steven, additional, Burkart, John M., additional, Bushinsky, David, additional, Campese, Vito M., additional, Cepeda, Celina Denise, additional, Chadha, Vimal, additional, Chan, Christopher T., additional, Chand, Deepa H., additional, Chang, Anthony, additional, Chang, Tara I., additional, Charytan, Chaim, additional, Chen, Joline L.T., additional, Chen, Wei, additional, Claudio, Ronco, additional, Collins, Allan J., additional, Crabtree, John H., additional, Crowley, Lisa E., additional, Cukor, Daniel, additional, Davies, Simon J., additional, Deger, Serpil Muge, additional, Depner, Thomas A., additional, Diaz-Buxo, Jose A., additional, Dinwiddie, Lesley C., additional, Dukkipati, Ramanath, additional, Duncan, Sarah E., additional, Fabrizi, Fabrizio, additional, Fischbach, Michel, additional, Fishbane, Steven, additional, Fissell, William Henry, additional, Foster, Bethany, additional, Galbusera, Miriam, additional, Gennari, F. John, additional, Ghannoum, Marc, additional, Ghazan-Shahi, Sassan, additional, Goldstein, Stuart L., additional, Gotch, Frank A., additional, Greenwood, Sharlene, additional, Haffner, Dieter, additional, Himmele, Rainer, additional, Holland, Janet E., additional, Holley, Jean L., additional, Holmes, Clifford, additional, Hooper, Stephen R., additional, Hothi, Daljit K., additional, Hou, Susan, additional, Hutchison, Alastair J., additional, Ikizler, T. Alp, additional, Jaber, Bertrand L., additional, Jassal, Sarbjit Vanita, additional, Kalantar-Zadeh, Kamyar, additional, Koh Jee Kam, Timothy, additional, Kaplan, Mark, additional, Kathuria, Pranay, additional, Kaufman, Jeffrey L., additional, Khanna, Ramesh, additional, Khosla, Neenoo, additional, Kimmel, Paul L., additional, Kooienga, Laura, additional, Koufaki, Pelagia, additional, Kovalik, Eugene C., additional, Kreuzer, Martin, additional, Krishna, Vinay Narasimha, additional, Krishnan, Mahesh, additional, Kuhlmann, Martin K., additional, Lakdawala, Ravi S., additional, Lam, Danica, additional, Lambie, Mark, additional, Lok, Charmaine E., additional, Mahan, John D., additional, Manley, Harold J., additional, Martin, Kevin J., additional, Martin, Paul, additional, Mathur, Piyush, additional, McIntyre, Christopher W., additional, Mehrotra, Rajnish, additional, Mehta, Ravindra L., additional, Mescia, Federica, additional, Mitsnefes, Mark M., additional, Modi, Gopesh K., additional, Moist, Louise, additional, Moodalbail, Divya G., additional, Moritz, Michael L., additional, Moss, Alvin H., additional, Nalesso, Federico, additional, Nessim, Sharon J., additional, Neul, Shari K., additional, Nissenson, Allen R., additional, Olyaei, Ali J., additional, Ortiz-Melo, David I., additional, Palmer, Biff F., additional, Palmer, Suetonia C., additional, Parfrey, Patrick S., additional, Pencille, Melissa, additional, Pham, Phuong-Chi T., additional, Pham, Phuong-Thu T., additional, Pittard, Joanne D., additional, Remuzzi, Giuseppe, additional, Rhee, Connie M., additional, Rigatto, Claudio, additional, Roberts, Darren M., additional, Rodriguez, Rudolph A., additional, Ronco, Claudio, additional, Rosenthal, Deborah, additional, Sadler, John H., additional, Satko, Scott G., additional, Schaefer, Franz, additional, Selewski, David T., additional, Sethna, Christine B., additional, Shah, Hitesh H., additional, Shapiro, Ron, additional, Sherman, Richard A., additional, Shroff, Rukshana, additional, Singer, Pamela, additional, Smith, Jodi M., additional, Somers, Michael J.G., additional, Soo, Euan, additional, Spinowitz, Bruce S., additional, Stein, Deborah, additional, Stivelman, John C., additional, Strippoli, Giovanni F.M., additional, Stronach, Lynsey, additional, Susantitaphong, Paweena, additional, Szeto, Cheuk-Chun, additional, Thomas, Rebecca, additional, Tolwani, Ashita, additional, Traum, Avram Z., additional, Vachharajani, Tushar, additional, Valentini, Rudolph P., additional, VanDeVoorde, René G., additional, Vardhan, Anand, additional, Vo, Thanh-Mai, additional, Wagner, Thor A., additional, Warady, Bradley A., additional, Wesseling-Perry, Katherine, additional, Westcott, Spencer, additional, Wetmore, James B., additional, Wille, Keith, additional, Williams, Mark E., additional, Wish, Jay B., additional, Yousaf, Farhanah, additional, Zaloszyc, Ariane, additional, and Zaritsky, Joshua, additional

Published
2017
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36. Design and population of the VALOR-CKD study: a multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of veverimer in slowing progression of chronic kidney disease in patients with metabolic acidosis.

Author

Mathur, Vandana S, Bushinsky, David A, Inker, Lesley, Klaerner, Gerrit, Li, Elizabeth, Parsell, Dawn, Perkovic, Vlado, Stasiv, Yuri, Walker, Michael, Wesson, Donald E, Wheeler, David C, and Tangri, Navdeep

Subjects
*CHRONIC kidney failure, *ACIDOSIS, *CHRONICALLY ill, *KIDNEY failure, *KIDNEY diseases, *KIDNEY transplantation
Abstract

Background Whether treating metabolic acidosis slows progression of chronic kidney disease (CKD) has not been established. Veverimer is a novel hydrochloric acid binder that removes acid from the gastrointestinal tract leading to an increase in serum bicarbonate; it is being developed to treat metabolic acidosis with the goal of slowing progression of CKD. Methods The VALOR-CKD trial is an international, randomized, multicenter, double-blind, placebo-controlled study designed to evaluate the effect of once-daily veverimer on kidney disease progression in patients with metabolic acidosis and CKD. Eligibility criteria include a serum bicarbonate in the range of 12–20 mmol/L and an estimated glomerular filtration rate (eGFR) of 20–40 mL/min/1.73 m2. The primary outcome is kidney disease progression defined as the development of end-stage kidney disease, a sustained decline in eGFR of >40% from baseline or death due to kidney failure. Key secondary endpoints include effects on physical function. Results Between December 2018 and December 2021, 1480 participants were randomized. The mean age at baseline was 65.1 years and 42% of the patients were female. The mean baseline eGFR was 29.1 mL/min/1.73 m2 and mean serum bicarbonate was 17.5 mmol/L. The median urine albumin-to-creatinine ratio at screening was 201 mg/g and the median 5-year predicted risk of kidney failure was 32%. Diabetes and hypertension were present in 56% and 98% of participants, respectively. Conclusions VALOR-CKD has recruited a large population of people with metabolic acidosis at high risk for CKD progression to determine the effects of veverimer on the risk of progressive loss of kidney function. [ABSTRACT FROM AUTHOR]

Published
2023
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44. Contributors

Author

Achermann, John C., primary, Aiello, Lloyd P., additional, Alexander, Erik K., additional, Allen, Rebecca H., additional, Altshuler, David, additional, Anderson, Mark S., additional, Atkinson, Mark A., additional, Bahn, Rebecca S., additional, Barker, Jennifer M., additional, Basson, Rosemary, additional, Berga, Sarah L., additional, Bhasin, Shalender, additional, Birnbaum, Morris J., additional, Black, Dennis M., additional, Bose, Anirban, additional, Boulton, Andrew J.M., additional, Braunstein, Glenn D., additional, Bremner, William J., additional, Brent, Gregory A., additional, Bringhurst, F. Richard, additional, Brownlee, Michael, additional, Bulun, Serdar E., additional, Burant, Charles F., additional, Bushinsky, David A., additional, Cone, Roger D., additional, Cooke, David W., additional, Cooper, Mark E., additional, Cryer, Philip E., additional, Dattani, Mehul T., additional, Davies, Terry F., additional, de Paula, Francisco J.A., additional, Demay, Marie B., additional, DiVall, Sara A., additional, Elmquist, Joel K., additional, Filetti, Sebastiano, additional, Gevers, Evelien F., additional, Ghigo, Ezio, additional, Goldberg, Anne C., additional, Goldberg, Ira J., additional, Gottlieb, Peter A., additional, Grinspoon, Steven K., additional, Grumbach, Melvin M., additional, Hay, Ian D., additional, Hayes, Frances J., additional, Hickey, Martha, additional, Hirschhorn, Joel N., additional, Ho, Ken K.Y., additional, Hughes, Ieuan A., additional, Kaiser, Ursula, additional, Kaunitz, Andrew M., additional, Klein, Samuel, additional, Kleinberg, David, additional, Kronenberg, Henry M., additional, Lamberts, Steven W.J., additional, Lanfranco, Fabio, additional, Larsen, P. Reed, additional, Laurberg, Peter, additional, Lazar, Mitchell A., additional, Loriaux, Lynn, additional, Low, Malcolm J., additional, Majithia, Amit R., additional, Marx, Stephen J., additional, Matsumoto, Alvin M., additional, Melmed, Shlomo, additional, Monk, Rebeca D., additional, Murray, Robert D., additional, Newell-Price, John D.C., additional, Nitsche, Joshua F., additional, Öberg, Kjell, additional, Plutzky, Jorge, additional, Polonsky, Kenneth S., additional, Radovick, Sally, additional, Robinson, Alan G., additional, Romijn, Johannes A., additional, Rosen, Clifford J., additional, Salvatore, Domenico, additional, Schlumberger, Martin-Jean, additional, Semenkovich, Clay F., additional, Sluss, Patrick M., additional, Stewart, Paul M., additional, Strasburger, Christian J., additional, Styne, Dennis M., additional, van den Beld, Annewieke W., additional, Vella, Adrian, additional, Verbalis, Joseph G., additional, Vinik, Aaron I., additional, Weetman, Anthony P., additional, Wells, Samuel A., additional, and Young, William F., additional

Published
2016
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45. Kidney Stones

Author

Bose, Anirban, primary, Monk, Rebeca D., additional, and Bushinsky, David A., additional

Published
2016
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46. Additional file 1 of Effects of veverimer on serum bicarbonate and physical function in women with chronic kidney disease and metabolic acidosis: a subgroup analysis from a randomised, controlled trial

Author

Mathur, Vandana S., Wesson, Donald E., Tangri, Navdeep, Li, Elizabeth, and Bushinsky, David A.

Abstract

Additional file 1: Supplemental Figure 1. Overall study design. Supplemental Figure 2. Veverimer Effect on Composite Endpoint at Treatment Week 52. Supplemental Table 1. Kidney Disease and Quality of Life ��� Physical Function Domain.

Published
2022
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