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1. Estimating glomerular filtration rate in kidney transplant recipients: considerations for selecting equations

Author

Agarwal, Krishna A., Adingwupu, Ogechi M., Tighiouart, Hocine, Miao, Shiyuan, Froissart, Marc, Mauer, Michael, Yang, Wei, Torres, Vicente, de Borst, Martin, Klintmalm, Goran, Poggio, Emilio D., Rossing, Peter, Velez, Ruben, Grubb, Anders, Rule, Andrew D., Shaffi, Kamran, Chami, Ashtar, Levey, Andrew S., and Inker, Lesley A.

Abstract

[Display omitted]

Published
2024
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2. Association of Integrated Proteomic and Metabolomic Modules with Risk of Kidney Disease Progression

Author

Schlosser, Pascal, Surapaneni, Aditya L., Borisov, Oleg, Schmidt, Insa M., Zhou, Linda, Anderson, Amanda, Deo, Rajat, Dubin, Ruth, Ganz, Peter, He, Jiang, Kimmel, Paul L., Li, Hongzhe, Nelson, Robert G., Porter, Anna C., Rahman, Mahboob, Rincon-Choles, Hernan, Shah, Vallabh, Unruh, Mark L., Vasan, Ramachandran S., Zheng, Zihe, Feldman, Harold I., Waikar, Sushrut S., Köttgen, Anna, Rhee, Eugene P., Coresh, Josef, Grams, Morgan E., Anderson, Amanda H., Appel, Lawrence J., Chen, Jing, Cohen, Debbie L., Dember, Laura M., Go, Alan S., Lash, James P., Rao, Panduranga S., Waikar, Sushrut, Schelling, Jeffrey, Denburg, Michelle, Furth, Susan, Warady, Bradley, Bonventre, Joseph, McMahon, Gearoid, Sabbisetti, Venkata, Coresh, Josef, Grams, Morgan, Rebholz, Casey, Abraham, Alison, Tin, Adriene, Parikh, Chirag, Klein, Jon, Coca, Steven, Ferket, Bart S., Nadkarni, Girish N., Rhee, Eugene, Kimmel, Paul L., Gossett, Daniel, Rovin, Brad, Shlipak, Michael G., Sarnak, M., Levey, Andrew S., Inker, Lesley A., Foster, Meredith, Gutiérrez, Orlando M., Ix, Joachim, Dubin, Ruth, Seegmiller, Jesse, Hostetter, Tom, Deo, Rajat, Li, Hongzhe, Ren, Yue, Schrauben, Sarah J., Feldman, Harold I., Anderson, Amanda, Mifflin, Theodore, Xie, Dawei, Shou, Haochang, Ballard, Shawn, Whitehead, Krista, Collins, Heather, Ramachandran, Vasan S., Greenberg, Jason, and Ganz, Peter

Published
2024
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3. Combination Treatment with Verinurad and Allopurinol in CKD

Author

Heerspink, Hiddo J.L., Stack, Austin G., Terkeltaub, Robert, Jongs, Niels, Inker, Lesley A., Bjursell, Magnus, Maklad, Noha, Perl, Shira, Eklund, Olof, Rikte, Tord, Sjöström, C. David, Perkovic, Vlado, Chmelickova, Hana, Lukac, Martin, Bucek, Petr, Drasnar, Tomas, Dussol, Bertrand, Guerrot, Dominique, Legrand, Eric, Boffa, Jean-Jacques, Halimi, Jean-Michel, Zaoui, Philippe, Letoha, Annamaria, Hajdu, Csaba, Pall, Denes, Peterfai, Eva, Csécsei, Gyöngyi, Bezzegh, Katalin, Deak, Laszlo, Konyves, Laszlo, Zsom, Marianna, Danos, Peter, Vangel, Sandor, Vasas, Szilard, Oroszlan, Tamas, Zilahi, Zsolt, Leiba, Adi, Grossman, Alon, Leibowitz, Avshalom, Itzhak, Baruch, Daoud, Deeb, Farber, Evgeny, Adawi, Faiad, Nakhoul, Farid M., Chernin, Gil, Kenis, Irina, Wainstein, Julio, Zeller, Lior, Elias, Mazen, Atar, Shaul, Frajewicki, Victor, Yagil, Yoram, Armaly, Zaher A., Esposito, Ciro, Viazzi, Francesca, Gambaro, Giovanni, Piatti, Piermarco, Bonadonna, Riccardo C., Arias Delgadillo, Cristhian Ronaldt, Flores, Fernando Jimenez, Aguilera Real, Manuel Enrique, Fajardo-Campos, Pedro, Violante Ortiz, Rafael Margarito, Luna Ceballos, Rosa Isela, Duran-Barragan, Sergio, Zytkiewicz-Jaruga, Danuta, Krzyzagorska, Ewa, Skokowska, Ewa, Klodawska, Katarzyna, Mordaka, Robert, Mazur, Stanislaw, Stasinska, Teresa, Sulowicz, Wladyslaw, Constantin, Ciprian, Negru, Doru, Paveliu, Fraga-Silvia, Negrisanu, Gabriela Doina, Szilagyi, Iosif, Busegeanu, Mihaela Magdalena G., Pena, Mihai Cosmin, Avram, Rodica Ioana, Ardelean, Silvia Luminita, Ilavska, Adriana, Dzupina, Andrej, Oroszova, Aniko, Kolesarova, Eva, Obetkova, Ida, Smatanova, Iveta, Babikova, Jana, Fulop, Peter, Haffner, Radovan, Rayner, Brian L., Kruger, Dawid Stephanus, Urbach, Dorothea Vera, Mitha, Essack, Vally Mahomed Latiff, Gulam Hoosain, Makan, Hemant, du Plessis, Hermanus, Jurgens, Jaco Cornelius, Reddy, Jeevren, Trokis, Julien S., McHarry, Kirsten, Distiller, Lawrence Allen, Mayet, Leila, Burgess, Lesley Jean, Van Zyl, Louis Johan, Joshi, Mukesh P., Sebastian, Peter John, Du Toit, Samantha Maria, Blignaut, Suzanne C., Serrano, Antonio Galan, Morales, Cristobal, Poch, Esteban, Mosquera, Eva Marquez, Castro, Fernando Cereto, Gonzalez Martinez, Francisco Javier, Perez- Contreras, Francisco Javier, Fernandez-Fresnedo, Gema, Garcia Mendez, Isabel Fuencisla, Perez, Jonay Pantoja, Martinez, Jordi Calabia, Gorriz Teruel, Jose Luis, Nieto Iglesias, Luis Javier, Munoz-Torres, Manuel, Munar Vila, Maria Antonia, Arenas Jimenez, Maria Dolores, Dominguez-Lopez, Marta E., Val, Miguel Hueso, Terrades, Natalia Ramos, Olmo, Rafael Santamaria, Malek Marin, Tamara Gelen, Arif, Ahmed A., Lee, Benjamin J., Mehta, Bhasker R., Baker, Bruce H., Jere, Charles S., Bains, David G., Stricklin, David G., Cheung, Deanna, Echeverri, Diego, Vera, Edgard, Heurich, Eva-Maria, Sterba, Gary A., Hernandez, German T., Paez, Henry E., Acosta, Idalia A., Ahmed, Intekhab, Sachmechi, Issac, Madu, Ivy-Joan E., Obhrai, Jagdeep Singh, Hammoud, Jamal A., Tumlin, James A., Cain, James, Moya-Hechevarria, Jaynier, Connaire, Jeffrey J., Haggiagi, Jehad, Odren, Jennifer A., Bellucci-Jackson, Jennifer M., Yan, Jieshi, Parker, John C., Tolins, Jonathan P., Gomez-Cortes, Jose D., Cardona, Jose F., Mandry, Jose M., Olivero, Juan Jorge, Hendon, Kendra S., Kaveh, Kianoosh, Kooienga, Laura A., Bermudez, Lidia R., Rich, Lisa M., Gold, Marina, Gonzalez, Marisela, Schaefer, Matthew E., Welch, Michelle, Moustafa, Moustafa A., Mussaji, Murtaza, Pergola, Pablo E., Phaosawasdi, Piangwarin, Silva, Ricardo A., Presas, Ricardo, Lynn, Robert I., Kronfli, Saeed J., Ventrapragada, Sailaja V., Niranjan, Sankar N., Husain, Sayed, Satko, Scott, Jabbour, Serge A., Rovner, Sergio F., Gouge, Steven F., Joshi, Sudhir S., Ramachandran Subramanian, Varagur Bala, Lane, Wendy, Calhoun, Wesley, and Durham, William

Published
2024
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5. Executive summary of the KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease: known knowns and known unknowns

Author

Levin, Adeera, Ahmed, Sofia B., Carrero, Juan Jesus, Foster, Bethany, Francis, Anna, Hall, Rasheeda K., Herrington, Will G., Hill, Guy, Inker, Lesley A., Kazancıoğlu, Rümeyza, Lamb, Edmund, Lin, Peter, Madero, Magdalena, McIntyre, Natasha, Morrow, Kelly, Roberts, Glenda, Sabanayagam, Dharshana, Schaeffner, Elke, Shlipak, Michael, Shroff, Rukshana, Tangri, Navdeep, Thanachayanont, Teerawat, Ulasi, Ifeoma, Wong, Germaine, Yang, Chih-Wei, Zhang, Luxia, Robinson, Karen A., Wilson, Lisa, Wilson, Renee F., Kasiske, Bertram L., Cheung, Michael, Earley, Amy, and Stevens, Paul E.

Abstract

The Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease (CKD) updates the KDIGO 2012 guideline and has been developed with patient partners, clinicians, and researchers around the world, using robust methodology. This update, based on a substantially broader base of evidence than has previously been available, reflects an exciting time in nephrology. New therapies and strategies have been tested in large and diverse populations that help to inform care; however, this guideline is not intended for people receiving dialysis nor those who have a kidney transplant. The document is sensitive to international considerations, CKD across the lifespan, and discusses special considerations in implementation. The scope includes chapters dedicated to the evaluation and risk assessment of people with CKD, management to delay CKD progression and its complications, medication management and drug stewardship in CKD, and optimal models of CKD care. Treatment approaches and actionable guideline recommendations are based on systematic reviews of relevant studies and appraisal of the quality of the evidence and the strength of recommendations which followed the “Grading of Recommendations Assessment, Development, and Evaluation” (GRADE) approach. The limitations of the evidence are discussed. The guideline also provides practice points, which serve to direct clinical care or activities for which a systematic review was not conducted, and it includes useful infographics and describes an important research agenda for the future. It targets a broad audience of people with CKD and their healthcare, while being mindful of implications for policy and payment.

Published
2024
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6. KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease

Author

Stevens, Paul E., Ahmed, Sofia B., Carrero, Juan Jesus, Foster, Bethany, Francis, Anna, Hall, Rasheeda K., Herrington, Will G., Hill, Guy, Inker, Lesley A., Kazancıoğlu, Rümeyza, Lamb, Edmund, Lin, Peter, Madero, Magdalena, McIntyre, Natasha, Morrow, Kelly, Roberts, Glenda, Sabanayagam, Dharshana, Schaeffner, Elke, Shlipak, Michael, Shroff, Rukshana, Tangri, Navdeep, Thanachayanont, Teerawat, Ulasi, Ifeoma, Wong, Germaine, Yang, Chih-Wei, Zhang, Luxia, and Levin, Adeera

Published
2024
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13. Effects of newer kidney protective agents on kidney endpoints provide implications for future clinical trials

Author

Heerspink, Hiddo J.L., Jongs, Niels, Neuen, Brendon L., Schloemer, Patrick, Vaduganathan, Muthiah, Inker, Lesley A., Fletcher, Robert A., Wheeler, David C., Bakris, George, Greene, Tom, Chertow, Glenn M., and Perkovic, Vlado

Abstract

Doubling of serum creatinine (equivalent to a 57% decline in the estimated glomerular filtration rate (eGFR)) is an accepted component of a composite kidney endpoint in clinical trials. Smaller declines in eGFR (40%, 50%) have been applied in several recently conducted clinical trials. Here, we assessed the effects of newer kidney protective agents on endpoints including smaller proportional declines in eGFR to compare relative event rates and the magnitude of observed treatment effects. We performed a post hoc analysis of 4401 patients in the CREDENCE, 4304 in the DAPA-CKD, 5734 in the FIDELIO-DKD, and 3668 in the SONAR trials, which assessed the effects of canagliflozin, dapagliflozin, finerenone and atrasentan in patients with chronic kidney disease. Effects of active therapies versus placebo on alternative composite kidney endpoints incorporating different eGFR decline thresholds (40%, 50%, or 57% eGFR reductions from baseline) with kidney failure or death due to kidney failure were compared. Cox-proportional hazards regression models were used to assess and compare treatment effects. During follow-up, event rates were higher for endpoints incorporating smaller versus larger eGFR decline thresholds. Compared to the treatment effects on kidney failure or death due to kidney failure, the magnitude of relative treatment effects was generally similar when considering composite endpoints incorporating smaller declines in eGFR. Hazard ratios for the four interventions ranged from 0.63 to 0.82 for the endpoint incorporating 40% eGFR decline and 0.59 to 0.76 for the endpoint incorporating 57% eGFR decline. Clinical trials incorporating a 40% eGFR decline in a composite endpoint would require approximately half the number of participants compared to a 57% eGFR decline with equivalent statistical power. Thus, in populations at high risk of CKD progression, the relative effects of newer kidney protective therapies appear generally similar across endpoints based on varying eGFR decline thresholds.

Published
2023
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14. A meta-analysis of GFR slope as a surrogate endpoint for kidney failure

Author

Inker, Lesley A., Collier, Willem, Greene, Tom, Miao, Shiyuan, Chaudhari, Juhi, Appel, Gerald B., Badve, Sunil V., Caravaca-Fontán, Fernando, Del Vecchio, Lucia, Floege, Jürgen, Goicoechea, Marian, Haaland, Benjamin, Herrington, William G., Imai, Enyu, Jafar, Tazeen H., Lewis, Julia B., Li, Philip K. T., Maes, Bart D., Neuen, Brendon L., Perrone, Ronald D., Remuzzi, Giuseppe, Schena, Francesco P., Wanner, Christoph, Wetzels, Jack F. M., Woodward, Mark, and Heerspink, Hiddo J. L.

Abstract

Glomerular filtration rate (GFR) decline is causally associated with kidney failure and is a candidate surrogate endpoint for clinical trials of chronic kidney disease (CKD) progression. Analyses across a diverse spectrum of interventions and populations is required for acceptance of GFR decline as an endpoint. In an analysis of individual participant data, for each of 66 studies (total of 186,312 participants), we estimated treatment effects on the total GFR slope, computed from baseline to 3 years, and chronic slope, starting at 3 months after randomization, and on the clinical endpoint (doubling of serum creatinine, GFR < 15 ml min−1per 1.73 m2or kidney failure with replacement therapy). We used a Bayesian mixed-effects meta-regression model to relate treatment effects on GFR slope with those on the clinical endpoint across all studies and by disease groups (diabetes, glomerular diseases, CKD or cardiovascular diseases). Treatment effects on the clinical endpoint were strongly associated with treatment effects on total slope (median coefficient of determination (R2) = 0.97 (95% Bayesian credible interval (BCI) 0.82–1.00)) and moderately associated with those on chronic slope (R2= 0.55 (95% BCI 0.25–0.77)). There was no evidence of heterogeneity across disease. Our results support the use of total slope as a primary endpoint for clinical trials of CKD progression.

Published
2023
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15. Change in Albuminuria and GFR Slope as Joint Surrogate End Points for Kidney Failure: Implications for Phase 2 Clinical Trials in CKD

Author

Heerspink, Hiddo J.L., Inker, Lesley A., Tighiouart, Hocine, Collier, Willem H., Haaland, Benjamin, Luo, Jiyu, Appel, Gerald B., Chan, Tak Mao, Estacio, Raymond O., Fervenza, Fernando, Floege, Jürgen, Imai, Enyu, Jafar, Tazeen H., Lewis, Julia B., Kam-Tao Li, Philip, Locatelli, Francesco, Maes, Bart D., Perna, Annalisa, Perrone, Ronald D., Praga, Manuel, Schena, Francesco P., Wanner, Christoph, Xie, Di, Greene, Tom, Schrier, Robert W., Hanratty, Rebecca, Maschio, Giuseppe, Carlo, Manno, Saddelli, Mauro, Brenner, Barry M., Lewis, Edmund, von Eynatten, Maximilian, de Jong, Paul E., van Essen, GG, Hou, Fan Fan, Chapman, Arlene, Torres, Vicente, Yu, Alan, Brosnahan, Godela, Chow, Kai-Ming, Szeto, Cheuk-Chun, Leung, Chi-Bon, Hunsicker, Lawrence G., Dwyer, Jamie, Pohl, Marc, Raz, Itamar, Del Vecchio, Lucia, Andrulli, Simeone, Pozzi, Claudio, Casartelli, Donatella, Malfait, Thomas, Vanacker, An, Caravaca-Fontán, Fernando, Trujillo, Hernando, Cavero, Teresa, Gutierrez, Eduardo, Beck, Gerald, Kusek, John, Eknoyan, Garabed, Ponticelli, Claudio, Montagnino, Giuseppe, Passerini, Patrizia, Moroni, Gabriella, Kobayashi, Fumiaki, Makino, Hirofumi, Ito, Sadayoshi, Chan, Juliana CN, Tang, Colin, Gaspari, Flavio, Lesti, Maria Domenica, Gherardi, Giulia, Gamba, Sara, Keane, William, Donadio, James, Rauen, Thomas, Seikrit, Claudia, Wied, Stefanie, Dwyer, Jamie, and Becker, Gavin J.

Published
2023
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19. The Kidney Failure Risk Equation: Evaluation of Novel Input Variables including eGFR Estimated Using the CKD-EPI 2021 Equation in 59 Cohorts

Author

Grams, Morgan E., Brunskill, Nigel J., Ballew, Shoshana H., Sang, Yingying, Coresh, Josef, Matsushita, Kunihiro, Surapaneni, Aditya, Bell, Samira, Carrero, Juan J., Chodick, Gabriel, Evans, Marie, Heerspink, Hiddo J.L., Inker, Lesley A., Iseki, Kunitoshi, Kalra, Philip A., Kirchner, H. Lester, Lee, Brian J., Levin, Adeera, Major, Rupert W., Medcalf, James, Nadkarni, Girish N., Naimark, David M.J., Ricardo, Ana C., Sawhney, Simon, Sood, Manish M., Staplin, Natalie, Stempniewicz, Nikita, Stengel, Benedicte, Sumida, Keiichi, Traynor, Jamie P., van den Brand, Jan, Wen, Chi-Pang, Woodward, Mark, Yang, Jae Won, Wang, Angela Yee-Moon, and Tangri, Navdeep

Published
2023
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25. Evaluation of Variation in the Performance of GFR Slope as a Surrogate End Point for Kidney Failure in Clinical Trials that Differ by Severity of CKD

Author

Collier, Willem, Inker, Lesley A., Haaland, Benjamin, Appel, Gerald B., Badve, Sunil V., Caravaca-Fontán, Fernando, Chalmers, John, Floege, Jürgen, Goicoechea, Marian, Imai, Enyu, Jafar, Tazeen H., Lewis, Julia B., Li, Philip K.T., Locatelli, Francesco, Maes, Bart D., Neuen, Brendon L., Perrone, Ronald D., Remuzzi, Giuseppe, Schena, Francesco P., Wanner, Christoph, Heerspink, Hiddo J.L., and Greene, Tom

Published
2023
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26. Effects of Bardoxolone Methyl in Alport Syndrome

Author

Warady, Bradley A., Pergola, Pablo E., Agarwal, Rajiv, Andreoli, Sharon, Appel, Gerald B., Bangalore, Sripal, Block, Geoffrey A., Chapman, Arlene B., Chin, Melanie P., Gibson, Keisha L., Goldsberry, Angie, Iijima, Kazumoto, Inker, Lesley A., Kashtan, Clifford E., Knebelmann, Bertrand, Mariani, Laura H., Meyer, Colin J., Nozu, Kandai, O’Grady, Megan, Rheault, Michelle N., Silva, Arnold L., Stenvinkel, Peter, Torra, Roser, and Chertow, Glenn M.

Published
2022
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28. Clinical Trial Considerations in Developing Treatments for Early Stages of Common, Chronic Kidney Diseases: A Scientific Workshop Cosponsored by the National Kidney Foundation and the US Food and Drug Administration

Author

Inker, Lesley A., Grams, Morgan E., Guðmundsdóttir, Hrefna, McEwan, Phil, Friedman, Robert, Thompson, Aliza, Weiner, Daniel E., Willis, Kerry, Heerspink, Hiddo J.L., Little, Dustin, Jha, Vivek, West, Melissa, Levey, Andrew S., Walsh, Michael, Mottl, Amy K., Tangri, Navdeep, Madero, Magdalena, Patel, Uptal D., Gillespie, Barbara S., Crews, Deidra C., and Levin, Adeera

Abstract

In the past decade, advances in the validation of surrogate end points for chronic kidney disease (CKD) progression have heightened interest in evaluating therapies in early CKD. In December 2020, the National Kidney Foundation sponsored a scientific workshop in collaboration with the US Food and Drug Administration (FDA) to explore patient, provider, and payor perceptions of the value of treating early CKD. The workshop reviewed challenges for trials in early CKD, including trial designs, identification of high-risk populations, and cost-benefit and safety considerations. Over 90 people representing a range of stakeholders including experts in clinical trials, nephrology, cardiology and endocrinology, patient advocacy organizations, patients, payors, health economists, regulators and policy makers attended a virtual meeting. There was consensus among the attendees that there is value to preventing the development and treating the progression of early CKD in people who are at high risk for progression, and that surrogate end points should be used to establish efficacy. Attendees also concluded that cost analyses should be holistic and include aspects beyond direct savings for treatment of kidney failure; and that safety data should be collected outside/beyond the duration of a clinical trial. Successful drug development and implementation of effective therapies will require collaboration across sponsors, patients, patient advocacy organizations, medical community, regulators, and payors.

Published
2022
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29. Association of Rosuvastatin Use with Risk of Hematuria and Proteinuria

Author

Shin, Jung-Im, Fine, Derek M., Sang, Yingying, Surapaneni, Aditya, Dunning, Stephan C., Inker, Lesley A., Nolin, Thomas D., Chang, Alex R., and Grams, Morgan E.

Abstract

Despite reports of hematuria and proteinuria with rosuvastatin use at the time of its approval by the US Food and Drug Administration (FDA), current labeling mentions dose reduction (maximum daily dose of 10 mg) only for patients with severe CKD. In this real-world study, 44%of patients with severe CKD were prescribed a higher dose of rosuvastatin than recommended by the FDA. Compared with atorvastatin, rosuvastatin use was associated with slightly increased risk of hematuria and proteinuria in a dose-dependent manner and slightly increased risk of kidney failure with replacement therapy; the cardiovascular benefits were similar. These findings suggest the need for greater care in prescribing and monitoring rosuvastatin, particularly in patients who receive high doses or who have severe CKD.

Published
2022
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30. A Prospective Cross-Sectional Study on the Performance of the 2021 CKD-EPI Equations Without Race in a Multiracial Population of Adults With Solid Tumors in Brazil

Author

Costa e Silva, Verônica T., Gil, Luiz A., Inker, Lesley A., Caires, Renato A., Costalonga, Elerson, Coura-Filho, George, Sapienza, Marcelo T., Castro, Gilberto, Estevez-Diz, Maria D.P., Zanetta, Dirce Maria T., Antonângelo, Leila, Marçal, Lia, Tighiouart, Hocine, Miao, Shiyuan, Mathew, Paul, Levey, Andrew S., and Burdmann, Emmanuel A.

Published
2023
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44. Longitudinal TNFR1 and TNFR2 and Kidney Outcomes: Results from AASK and VA NEPHRON-D

Author

Chen, Teresa K., Coca, Steven G., Estrella, Michelle M., Appel, Lawrence J., Coresh, Josef, Thiessen Philbrook, Heather, Obeid, Wassim, Fried, Linda F., Heerspink, Hiddo J.L., Ix, Joachim H., Shlipak, Michael G., Kimmel, Paul L., Parikh, Chirag R., Grams, Morgan E., Ramachandran, Vasan S., Massaro, Joseph, Clish, Clary, Schelling, Jeffrey, Denburg, Michelle, Furth, Susan, Warady, Bradley, Bonventre, Joseph, Waikar, Sushrut, McMahon, Gearoid, Sabbisetti, Venkata, Coresh, Josef, Grams, Morgan, Rebholz, Casey, Abraham, Alison, Tin, Adrienne, Parikh, Chirag, Klein, Jon, Coca, Steven, Ferket, Bart S, Nadkarni, Girish N., Rhee, Eugene, Kimmel, Paul L., Gossett, Daniel, Rovin, Brad, Shlipak, Michael G., Sarnak, M, Levey, Andrew S., Inker, Lesley A., Foster, Meredith, Guti?rrez, Orlando M., Ix, Joachim, Dubin, Ruth, Seegmiller, Jesse, Hostetter, Tom, Deo, Rajat, Feldman, Harold I., Anderson, Amanda, Mifflin, Theodore, Xie, Dawei, Shou, Haochang, Ballard, Shawn, Whitehead, Krista, Collins, Heather, Greenberg, Jason, and Ganz, Peter

Abstract

Recent research suggests that biomarkers of the TNF pathway (TNFR1 and TNFR2) are associated with worse kidney outcomes. Most of these studies, however, evaluated baseline levels rather than longitudinal changes. In two cohorts (AASK, which enrolled Black people with CKD attributed to hypertension, and VA NEPHRON-D, which enrolled veterans with albuminuric CKD and type 2 diabetes), greater longitudinal increases in serum or plasma TNFR1 and TNFR2 were associated with higher risks of ESKD in AASK and subsequent kidney function decline in VA NEPHRON-D. These associations were independent of baseline biomarker level and kidney function. Longitudinal trajectories in TNFR1 and TNFR2 may ultimately allow improved risk assessment for kidney failure in persons with CKD.

Published
2022
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45. A prospective cross-sectional study estimated glomerular filtration rate from creatinine and cystatin C in adults with solid tumors

Author

Costa e Silva, Verônica T., Gil, Luiz A., Inker, Lesley A., Caires, Renato A., Costalonga, Elerson, Coura-Filho, George, Sapienza, Marcelo T., Castro, Gilberto, Estevez-Diz, Maria DP., Zanetta, Dirce Maria T., Antonângelo, Leila, Marçal, Lia, Tighiouart, Hocine, Miao, Shiyuan, Mathew, Paul, Levey, Andrew S., and Burdmann, Emmanuel A.

Abstract

Current guidelines recommend estimating glomerular filtration rate (eGFR) using creatinine (eGFRcr) with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation as the first test for GFR evaluation, but the Cockcroft-Gault (CG) equation is still commonly used in oncology practice and clinical trials despite increasing evidence of its inaccuracy compared to measured GFR (mGFR). Guidelines recommend eGFR using cystatin C (eGFRcys) or both markers (eGFRcr-cys) as a confirmatory test, but neither was carefully evaluated in cancer patients. Therefore, we compared performance of the CKD-EPI equations and others to the CG equation in adults with a variety of solid tumors. The mGFR was determined by plasma clearance of 51Cr-EDTA. Bias was defined as the median of the differences between mGFR and eGFR while accuracy was defined as the percentage of estimates that differed by more than 30% from the measured GFR (1–P30). We prospectively recruited 1,200 patients between April 2015 and September 2017 with a mean age and mGFR of 58.8 years and 78.4 ml/min/1.73m2, respectively. Bias among eGFRcr equations varied from -8.1 to +6.1 ml/min/1.73 m2. CG was the least accurate, 1-P30 (95% confidence interval) was 24.9 (22.4- 27.3)%; CKD-EPI had 1-P30 of 19.1 (16.8-21.2)% while eGFRcr-cys had the best performance: bias -2.0 (-2.6 to -1.1) ml/min/1.73m2and 1-P30 7.8 (6.3-9.4)%. Thus, the CG equation should not be preferred over CKD-EPI equation, and eGFRcr-cys can be used as a confirmatory test in adults with solid tumors. Hence, a major policy implication would be to adopt general practice guideline-recommended methods for GFR evaluation in oncology practice and clinical trials.

Published
2022
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46. Acute Treatment Effects on GFR in Randomized Clinical Trials of Kidney Disease Progression

Author

Neuen, Brendon L., Tighiouart, Hocine, Heerspink, Hiddo J.L., Vonesh, Edward F., Chaudhari, Juhi, Miao, Shiyuan, Chan, Tak Mao, Fervenza, Fernando C., Floege, J?rgen, Goicoechea, Marian, Herrington, William G., Imai, Enyu, Jafar, Tazeen H., Lewis, Julia B., Li, Philip Kam-Tao, Locatelli, Francesco, Maes, Bart D., Perrone, Ronald D., Praga, Manuel, Perna, Annalisa, Schena, Francesco P., Wanner, Christoph, Wetzels, Jack F.M., Woodward, Mark, Xie, Di, Greene, Tom, and Inker, Lesley A.

Abstract

GFR slope has been proposed as a surrogate endpoint for progression to kidney failure in clinical trials studying patients with CKD. Acute or immediate effects on GFR after treatment initiation may complicate the interpretation of long-term treatment effects. In this large meta-analysis of 53 randomized clinical studies of CKD progression, the authors found the magnitude and nature of acute effects are variable across different interventions and may be larger at a higher baseline GFR. Negative acute effects (such as an acute reduction in GFR) were observed in trials of renin-angiotensin system blockade and BP lowering, whereas positive acute effects were more common in trials of immunosuppressive therapies. Such information can inform the optimal design and analysis plan for randomized clinical trials in CKD.

Published
2022
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48. Cystatin C and Muscle Mass in Patients With Heart Failure.

Author

Ivey-Miranda, Juan B., Inker, Lesley A., Griffin, Matthew, Rao, Veena, Maulion, Christopher, Turner, Jeffrey M., Wilson, F. Perry, Tang, W.H. Wilson, Levey, Andrew S., and Testani, Jeffrey M.

Abstract

Background: The estimated glomerular filtration rate (eGFR) from cystatin C (eGFRcys) is often considered a more accurate method to assess GFR compared with an eGFR from creatinine (eGFRcr) in the setting of heart failure (HF) and sarcopenia, because cystatin C is hypothesized to be less affected by muscle mass than creatinine. We evaluated (1) the association of muscle mass with cystatin C, (2) the accuracy of eGFRcys, and (3) the association of eGFRcys with mortality given muscle mass.Methods and Results: We included 293 patients admitted with HF. Muscle mass was estimated with a validated creatinine excretion-based equation. Accuracy of eGFRcys and eGFRcr was compared with measured creatinine clearance. Cystatin C and creatinine were 31.7% and 59.9% higher per 14 kg higher muscle mass at multivariable analysis (both P < .001). At lower muscle mass, eGFRcys and eGFRcr overestimated the measured creatinine clearance. At higher muscle mass, eGFRcys underestimated the measured creatinine clearance, but eGFRcr did not. After adjusting for muscle mass, neither eGFRcys nor eGFRcr were associated with mortality (both P > .19).Conclusions: Cystatin C levels were associated with muscle mass in patients with HF, which could potentially decrease the accuracy of eGFRcys. In HF where aberrations in body composition are common, eGFRcys, like eGFRcr, may not provide accurate GFR estimations and results should be interpreted cautiously. [ABSTRACT FROM AUTHOR]

Published
2021
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49. Effect of Loop Diuretics on the Fractional Excretion of Urea in Decompensated Heart Failure.

Author

COX, ZACHARY L., SURY, KRISHNA, RAO, VEENA S., IVEY-MIRANDA, JUAN B., GRIFFIN, MATTHEW, MAHONEY, DEVIN, GOMEZ, NICOLE, FLEMING, JAMES H., INKER, LESLEY A., COCA, STEVEN G., TURNER, JEFF, WILSON, F. PERRY, and TESTANI, JEFFREY M.

Abstract

Background: Fractional excretion of urea (FEUrea) is often used to understand the etiology of acute kidney injury (AKI) in patients receiving diuretics. Although FEUrea demonstrates diagnostic superiority over fractional excretion of sodium (FENa), clinicians often assume FEUrea is not affected by diuretics.Objective: To assess the intravenous loop diuretic effect on FEUrea.Methods: We analyzed a prospective cohort (n=297) hospitalized with hypervolemic heart failure at Yale New Haven Hospital System. FENa and FEUrea were calculated at baseline and serially after diuretics. The change in FEUrea at peak diuresis was compared with the pre-diuretic baseline.Results: Mean baseline FEUrea was 35.2% ± 10.5% and increased by a mean 5.6% ± 10.5% following 80 mg (40-160 mg) of furosemide equivalents (P < .001). The magnitude of change in FEUrea was clinically important as the distribution of change in FEUrea was similar to the overall distribution of baseline FEUrea. Change in FEUrea was related to the diuretic response (r = 0.61, P < .001), with a larger FEUrea increase in diuretic responders (8.8%, interquartile range [IQR]: 1.8-16.9) than non-responders (1.2%, IQR: -3.2 to 5.5; P < .001). Diuretic administration reclassified 27% of patients between low and high FEUrea groups across a 35% threshold. Neither change in FEUrea nor percentage reclassified out of a low FEUrea category differed between patients with and without AKI (P > .63 for both).Conclusions: FEUrea is meaningfully affected by loop diuretics. The degree of change in FEUrea is highly variable between patients and commonly of a magnitude that could reclassify across categories of FEUrea. [ABSTRACT FROM AUTHOR]

Published
2020
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50. Metabolite Biomarkers of CKD Progression in Children

Author

Denburg, Michelle R., Xu, Yunwen, Abraham, Alison G., Coresh, Josef, Chen, Jingsha, Grams, Morgan E., Feldman, Harold I., Kimmel, Paul L., Rebholz, Casey M., Rhee, Eugene P., Vasan, Ramachandran S., Warady, Bradley A., Furth, Susan L., Ramachandran, Vasan S., Massaro, Joseph, Clish, Clary, Schelling, Jeffrey, Denburg, Michelle, Furth, Susan, Warady, Bradley, Bonventre, Joseph, Waikar, Sushrut, McMahon, Gearoid, Sabbisetti, Venkata, Coresh, Josef, Grams, Morgan, Rebholz, Casey, Abraham, Alison, Tin, Adriene, Parikh, Chirag, Klein, Jon, Coca, Steven, Ferket, Bart S, Nadkarni, Girish N., Rhee, Eugene, Kimmel, Paul L., Gossett, Daniel, Rovin, Brad, Shlipak, Michael G., Sarnak, M, Levey, Andrew S., Inker, Lesley A., Foster, Meredith, Gutiérrez, Orlando M., Ix, Joachim, Dubin, Ruth, Seegmiller, Jesse, Hostetter, Tom, Deo, Rajat, Feldman, Harold I., Anderson, Amanda, Mifflin, Theodore, Xie, Dawei, Shou, Haochang, Ballard, Shawn, Whitehead, Krista, Collins, Heather, Greenberg, Jason, and Ganz, Peter

Published
2021
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