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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Veröffentlicht in:Journal of the American Society of Nephrology Jg. 30; H. 9; S. 1746
Hauptverfasser: 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
Format: Journal Article
Sprache:Englisch
Veröffentlicht: United States 01.09.2019
Schlagworte:
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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Zusammenfassung: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.
Bibliographie:ObjectType-Article-1
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content type line 23
ISSN:1533-3450
1533-3450
DOI:10.1681/ASN.2019010008