Literature DB >> 31292199

Evaluating Glomerular Filtration Rate Slope as a Surrogate End Point for ESKD in Clinical Trials: An Individual Participant Meta-Analysis of Observational Data.

Morgan E Grams1, Yingying Sang1, Shoshana H Ballew1, Kunihiro Matsushita1, Brad C Astor2,3, Juan Jesus Carrero4, Alex R Chang5, Lesley A Inker6, Timothy Kenealy2,7, Csaba P Kovesdy8,9, Brian J Lee10, Adeera Levin11, David Naimark12, Michelle J Pena13, Jesse D Schold14,15, Varda Shalev16, Jack F M Wetzels17, Mark Woodward1,18,19, Ron T Gansevoort20, Andrew S Levey6, Josef Coresh21.   

Abstract

BACKGROUND: Decline in eGFR is a biologically plausible surrogate end point for the progression of CKD in clinical trials. However, it must first be tested to ensure strong associations with clinical outcomes in diverse populations, including patients with higher eGFR.
METHODS: To investigate the association between 1-, 2-, and 3-year changes in eGFR (slope) with clinical outcomes over the long term, we conducted a random effects meta-analysis of 3,758,551 participants with baseline eGFR≥60 ml/min per 1.73 m2 and 122,664 participants with eGFR<60 ml/min per 1.73 m2 from 14 cohorts followed for an average of 4.2 years.
RESULTS: Slower eGFR decline by 0.75 ml/min per 1.73 m2 per year over 2 years was associated with lower risk of ESKD in participants with baseline eGFR≥60 ml/min per 1.73 m2 (adjusted hazard ratio, 0.70; 95% CI, 0.68 to 0.72) and eGFR<60 ml/min per 1.73 m2 (0.71; 95% CI, 0.68 to 0.74). The relationship was stronger with 3-year slope. For a rapidly progressing population with predicted 5-year risk of ESKD of 8.3%, an intervention that reduced eGFR decline by 0.75 ml/min per 1.73 m2 per year over 2 years would reduce the ESKD risk by 1.6%. For a hypothetical low-risk population with a predicted 5-year ESKD risk of 0.58%, the same intervention would reduce the risk by only 0.13%.
CONCLUSIONS: Slower decline in eGFR was associated with lower risk of subsequent ESKD, even in participants with eGFR≥60 ml/min per 1.73 m2, but those with the highest risk would be expected to benefit the most.
Copyright © 2019 by the American Society of Nephrology.

Entities:  

Keywords:  chronic kidney disease; end-stage renal disease; glomerular filtration rate; progression of chronic renal failure

Mesh:

Substances:

Year:  2019        PMID: 31292199      PMCID: PMC6727262          DOI: 10.1681/ASN.2019010008

Source DB:  PubMed          Journal:  J Am Soc Nephrol        ISSN: 1046-6673            Impact factor:   10.121


  19 in total

1.  Blood pressure in early autosomal dominant polycystic kidney disease.

Authors:  Robert W Schrier; Kaleab Z Abebe; Ronald D Perrone; Vicente E Torres; William E Braun; Theodore I Steinman; Franz T Winklhofer; Godela Brosnahan; Peter G Czarnecki; Marie C Hogan; Dana C Miskulin; Frederic F Rahbari-Oskoui; Jared J Grantham; Peter C Harris; Michael F Flessner; Kyongtae T Bae; Charity G Moore; Arlene B Chapman
Journal:  N Engl J Med       Date:  2014-11-15       Impact factor: 91.245

Review 2.  The number, quality, and coverage of randomized controlled trials in nephrology.

Authors:  Giovanni F M Strippoli; Jonathan C Craig; Francesco P Schena
Journal:  J Am Soc Nephrol       Date:  2004-02       Impact factor: 10.121

3.  Chronic kidney disease and the public health: gaps in evidence from interventional trials.

Authors:  Jonathan Himmelfarb
Journal:  JAMA       Date:  2007-06-20       Impact factor: 56.272

Review 4.  Surrogate end points for clinical trials of kidney disease progression.

Authors:  Lesley A Stevens; Tom Greene; Andrew S Levey
Journal:  Clin J Am Soc Nephrol       Date:  2006-06-14       Impact factor: 8.237

5.  GFR decline as an end point in trials of CKD: a viewpoint from the FDA.

Authors:  Aliza Thompson; John Lawrence; Norman Stockbridge
Journal:  Am J Kidney Dis       Date:  2014-10-31       Impact factor: 8.860

6.  Effect of blood pressure lowering and antihypertensive drug class on progression of hypertensive kidney disease: results from the AASK trial.

Authors:  Jackson T Wright; George Bakris; Tom Greene; Larry Y Agodoa; Lawrence J Appel; Jeanne Charleston; DeAnna Cheek; Janice G Douglas-Baltimore; Jennifer Gassman; Richard Glassock; Lee Hebert; Kenneth Jamerson; Julia Lewis; Robert A Phillips; Robert D Toto; John P Middleton; Stephen G Rostand
Journal:  JAMA       Date:  2002-11-20       Impact factor: 56.272

7.  Effect of ramipril vs amlodipine on renal outcomes in hypertensive nephrosclerosis: a randomized controlled trial.

Authors:  L Y Agodoa; L Appel; G L Bakris; G Beck; J Bourgoignie; J P Briggs; J Charleston; D Cheek; W Cleveland; J G Douglas; M Douglas; D Dowie; M Faulkner; A Gabriel; J Gassman; T Greene; Y Hall; L Hebert; L Hiremath; K Jamerson; C J Johnson; J Kopple; J Kusek; J Lash; J Lea; J B Lewis; M Lipkowitz; S Massry; J Middleton; E R Miller; K Norris; D O'Connor; A Ojo; R A Phillips; V Pogue; M Rahman; O S Randall; S Rostand; G Schulman; W Smith; D Thornley-Brown; C C Tisher; R D Toto; J T Wright; S Xu
Journal:  JAMA       Date:  2001-06-06       Impact factor: 56.272

8.  Tolvaptan in patients with autosomal dominant polycystic kidney disease.

Authors:  Vicente E Torres; Arlene B Chapman; Olivier Devuyst; Ron T Gansevoort; Jared J Grantham; Eiji Higashihara; Ronald D Perrone; Holly B Krasa; John Ouyang; Frank S Czerwiec
Journal:  N Engl J Med       Date:  2012-11-03       Impact factor: 91.245

9.  A new equation to estimate glomerular filtration rate.

Authors:  Andrew S Levey; Lesley A Stevens; Christopher H Schmid; Yaping Lucy Zhang; Alejandro F Castro; Harold I Feldman; John W Kusek; Paul Eggers; Frederick Van Lente; Tom Greene; Josef Coresh
Journal:  Ann Intern Med       Date:  2009-05-05       Impact factor: 25.391

10.  Cohort profile: the chronic kidney disease prognosis consortium.

Authors:  Kunihiro Matsushita; Shoshana H Ballew; Brad C Astor; Paul E de Jong; Ron T Gansevoort; Brenda R Hemmelgarn; Andrew S Levey; Adeera Levin; Chi-Pang Wen; Mark Woodward; Josef Coresh
Journal:  Int J Epidemiol       Date:  2012-12-12       Impact factor: 7.196

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  34 in total

1.  Clinical Trial Data Sharing: The Time Is Now.

Authors:  Josephine P Briggs; Paul M Palevsky
Journal:  J Am Soc Nephrol       Date:  2019-08-13       Impact factor: 10.121

2.  GFR Slope as a Surrogate End Point for Kidney Disease Progression in Clinical Trials: A Meta-Analysis of Treatment Effects of Randomized Controlled Trials.

Authors:  Lesley A Inker; Hiddo J L Heerspink; Hocine Tighiouart; Andrew S Levey; Josef Coresh; Ron T Gansevoort; Andrew L Simon; Jian Ying; Gerald J Beck; Christoph Wanner; Jürgen Floege; Philip Kam-Tao Li; Vlado Perkovic; Edward F Vonesh; Tom Greene
Journal:  J Am Soc Nephrol       Date:  2019-07-10       Impact factor: 10.121

3.  Performance of GFR Slope as a Surrogate End Point for Kidney Disease Progression in Clinical Trials: A Statistical Simulation.

Authors:  Tom Greene; Jian Ying; Edward F Vonesh; Hocine Tighiouart; Andrew S Levey; Josef Coresh; Jennifer S Herrick; Enyu Imai; Tazeen H Jafar; Bart D Maes; Ronald D Perrone; Lucia Del Vecchio; Jack F M Wetzels; Hiddo J L Heerspink; Lesley A Inker
Journal:  J Am Soc Nephrol       Date:  2019-07-10       Impact factor: 10.121

4.  Safety and effectiveness of ipragliflozin in Japanese patients with type 2 diabetes mellitus and impaired renal function: subgroup analysis of a 3-year post-marketing surveillance study (STELLA-LONG TERM).

Authors:  Kazuyuki Tobe; Hiroshi Maegawa; Ichiro Nakamura; Satoshi Uno
Journal:  Diabetol Int       Date:  2020-11-23

5.  Urinary excretion of epidermal growth factor and rapid loss of kidney function.

Authors:  Jon Viljar Norvik; Laura R Harskamp; Viji Nair; Kerby Shedden; Marit D Solbu; Bjørn O Eriksen; Matthias Kretzler; Ron T Gansevoort; Wenjun Ju; Toralf Melsom
Journal:  Nephrol Dial Transplant       Date:  2021-09-27       Impact factor: 5.992

6.  Acute Treatment Effects on GFR in Randomized Clinical Trials of Kidney Disease Progression.

Authors:  Brendon L Neuen; Hocine Tighiouart; Hiddo J L Heerspink; Edward F Vonesh; Juhi Chaudhari; Shiyuan Miao; Tak Mao Chan; Fernando C Fervenza; Jürgen Floege; Marian Goicoechea; William G Herrington; Enyu Imai; Tazeen H Jafar; Julia B Lewis; Philip Kam-Tao Li; Francesco Locatelli; Bart D Maes; Ronald D Perrone; Manuel Praga; Annalisa Perna; Francesco P Schena; Christoph Wanner; Jack F M Wetzels; Mark Woodward; Di Xie; Tom Greene; Lesley A Inker
Journal:  J Am Soc Nephrol       Date:  2021-12-03       Impact factor: 10.121

7.  Initial Validation of a Machine Learning-Derived Prognostic Test (KidneyIntelX) Integrating Biomarkers and Electronic Health Record Data To Predict Longitudinal Kidney Outcomes.

Authors:  Kinsuk Chauhan; Girish N Nadkarni; Fergus Fleming; James McCullough; Cijiang J He; John Quackenbush; Barbara Murphy; Michael J Donovan; Steven G Coca; Joseph V Bonventre
Journal:  Kidney360       Date:  2020-06-30

8.  Estimated GFR Slope Across CKD Stages in Primary Hyperoxaluria Type 1.

Authors:  Prince Singh; Lisa E Vaughan; Phillip J Schulte; David J Sas; Dawn S Milliner; John C Lieske
Journal:  Am J Kidney Dis       Date:  2022-03-16       Impact factor: 11.072

9.  Utility of the 2018 revised ISN/RPS thresholds for glomerular crescents in childhood-onset lupus nephritis: a Pediatric Nephrology Research Consortium study.

Authors:  Pooja Patel; Marietta de Guzman; M John Hicks; Joseph G Maliakkal; Michelle N Rheault; David T Selewski; Katherine Twombley; Jason M Misurac; Cheryl L Tran; Alexandru R Constantinescu; Ali M Onder; Meredith Seamon; Wacharee Seeherunvong; Vaishali Singh; Cynthia Pan; Daryl M Okamura; Abiodun Omoloja; Mahmoud Kallash; William E Smoyer; Guillermo Hidalgo; Scott E Wenderfer
Journal:  Pediatr Nephrol       Date:  2022-03-28       Impact factor: 3.651

Review 10.  Association of Treatment Effects on Early Change in Urine Protein and Treatment Effects on GFR Slope in IgA Nephropathy: An Individual Participant Meta-analysis.

Authors:  Lesley A Inker; Hiddo J L Heerspink; Hocine Tighiouart; Juhi Chaudhari; Shiyuan Miao; Ulysses Diva; Alex Mercer; Gerald B Appel; James V Donadio; Jürgen Floege; Philip K T Li; Bart D Maes; Francesco Locatelli; Manuel Praga; Francesco P Schena; Andrew S Levey; Tom Greene
Journal:  Am J Kidney Dis       Date:  2021-03-26       Impact factor: 11.072

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