SynthesisJournal of the American Society of Nephrology : JASN2019
Performance of GFR Slope as a Surrogate End Point for Kidney Disease Progression in Clinical Trials: A Statistical Simulation.
Synthesis in Journal of the American Society of Nephrology : JASN, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 67 papers, 7 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
67 citing papers in PubMed, 7 syntheses or guidelines pooled it, 112 citations in OpenAlex.
- Guidelines for clinical evaluation of chronic kidney disease in early stages : AMED research on regulatory science of pharmaceuticals and medical devices.Clinical and experimental nephrology · 2024Guideline
- A meta-analysis of GFR slope as a surrogate endpoint for kidney failure.Nature medicine · 2023Pooled it
- The applications of DNA methylation as a biomarker in kidney transplantation: a systematic review.Clinical epigenetics · 2022Pooled it
- Treatments for Chronic Kidney Disease: A Systematic Literature Review of Randomized Controlled Trials.Advances in therapy · 2022Pooled it
- Association of Treatment Effects on Early Change in Urine Protein and Treatment Effects on GFR Slope in IgA Nephropathy: An Individual Participant Meta-analysis.American journal of kidney diseases : the official journal of the National Kidney Foundation · 2021Pooled it
- Evaluating Glomerular Filtration Rate Slope as a Surrogate End Point for ESKD in Clinical Trials: An Individual Participant Meta-Analysis of Observational Data.Journal of the American Society of Nephrology : JASN · 2019Pooled it
- GFR Slope as a Surrogate End Point for Kidney Disease Progression in Clinical Trials: A Meta-Analysis of Treatment Effects of Randomized Controlled Trials.Journal of the American Society of Nephrology : JASN · 2019Pooled it
- Ertugliflozin and Slope of Chronic eGFR: Prespecified Analyses from the Randomized VERTIS CV Trial.Clinical journal of the American Society of Nephrology : CJASN · 2021Trial
- Trial
- Remission of hematuria is associated with a better prognosis in immunoglobulin A nephropathy.Kidney research and clinical practice · 2026Article
- Length of Follow-Up Time Needed for Stable eGFR Slope Estimation in Glomerular Disease.Kidney360 · 2026Article
- A U-Shaped Association: The First-Year eGFR Slope and Mortality Risk in Multiple Myeloma.Cancer medicine · 2026Article
- [Surrogate markers in chronic kidney disease : Estimated glomerular filtration rate and albuminuria in clinical practice and in studies].Innere Medizin (Heidelberg, Germany) · 2026Review
- eGFR slope improvement with SGLT2 inhibitors is not statistically associated with changes in urinary protein in Japanese CKD patients: a single-center real-world analysis.Clinical and experimental nephrology · 2026Article
- Renal tubular calcium phosphate microcrystallopathy and age-related kidney function decline: The Aging Kidney Study.Clinical kidney journal · 2026Article
- Prognosis and predictive factors in pediatric IgA nephropathy.Pediatric nephrology (Berlin, Germany) · 2026Article
- Finerenone and eGFR Slope across Different Levels of Baseline Albuminuria and eGFR: Insights from FINEARTS-HF.Clinical journal of the American Society of Nephrology : CJASN · 2026Article
- Association between the uric acid to high-density lipoprotein cholesterol ratio and estimated glomerular filtration rate decline in community-managed patients with type 2 diabetes: a retrospective cohort study.Frontiers in nutrition · 2026Article
- Efficacy and safety of Telitacicept in IgA nephropathy and its impact on urinary Gd-IgA1: insights from a real-world study.Frontiers in immunology · 2026Article
- Considerations for Using eGFR Slope as an End Point in Clinical Trials.Journal of the American Society of Nephrology : JASN · 2026Article
7 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 11 institutions in 6 countries.
Funding
Abstract
backgroundRandomized trials of CKD treatments traditionally use clinical events late in CKD progression as end points. This requires costly studies with large sample sizes and long follow-up. Surrogate end points like GFR slope may speed up the evaluation of new therapies by enabling smaller studies with shorter follow-up.
methodsWe used statistical simulations to identify trial situations where GFR slope provides increased statistical power compared with the clinical end point of doubling of serum creatinine or kidney failure. We simulated GFR trajectories based on data from 47 randomized treatment comparisons. We evaluated the sample size required for adequate statistical power based on GFR slopes calculated from baseline and from 3 months follow-up.
resultsIn most scenarios where the treatment has no acute effect, analyses of GFR slope provided similar or improved statistical power compared with the clinical end point, often allowing investigators to shorten follow-up by at least half while simultaneously reducing sample size. When patients' GFRs are higher, the power advantages of GFR slope increase. However, acute treatment effects within several months of randomization can increase the risk of false conclusions about therapies based on GFR slope. Care is needed in study design and analysis to avoid such false conclusions.
conclusionsUse of GFR slope can substantially increase statistical power compared with the clinical end point, particularly when baseline GFR is high and there is no acute effect. The optimum GFR-based end point depends on multiple factors including the rate of GFR decline, type of treatment effect and study design.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.