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

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. To investigate the association between 1-,...

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Vydáno v:	Journal of the American Society of Nephrology Ročník 30; číslo 9; s. 1746
Hlavní autoři:	Grams, Morgan E, Sang, Yingying, Ballew, Shoshana H, Matsushita, Kunihiro, Astor, Brad C, Carrero, Juan Jesus, Chang, Alex R, Inker, Lesley A, Kenealy, Timothy, Kovesdy, Csaba P, Lee, Brian J, Levin, Adeera, Naimark, David, Pena, Michelle J, Schold, Jesse D, Shalev, Varda, Wetzels, Jack F M, Woodward, Mark, Gansevoort, Ron T, Levey, Andrew S, Coresh, Josef
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	United States 01.09.2019
Témata:	Biomarkers Disease Progression Glomerular Filtration Rate Humans Kidney Failure, Chronic - mortality Kidney Failure, Chronic - physiopathology Kidney Failure, Chronic - therapy Observational Studies as Topic Predictive Value of Tests Randomized Controlled Trials as Topic Renal Replacement Therapy chronic kidney disease progression of chronic renal failure end-stage renal disease glomerular filtration rate
ISSN:	1533-3450, 1533-3450
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Shrnutí:	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. 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 m and 122,664 participants with eGFR<60 ml/min per 1.73 m from 14 cohorts followed for an average of 4.2 years. Slower eGFR decline by 0.75 ml/min per 1.73 m per year over 2 years was associated with lower risk of ESKD in participants with baseline eGFR≥60 ml/min per 1.73 m (adjusted hazard ratio, 0.70; 95% CI, 0.68 to 0.72) and eGFR<60 ml/min per 1.73 m (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 m 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%. Slower decline in eGFR was associated with lower risk of subsequent ESKD, even in participants with eGFR≥60 ml/min per 1.73 m , but those with the highest risk would be expected to benefit the most.
Bibliografie:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	1533-3450 1533-3450
DOI:	10.1681/ASN.2019010008