Evidence map›Paper›PMID 24787763›Full record

SynthesisAmerican journal of kidney diseases : the official journal of the National Kidney Foundation2014

Early change in proteinuria as a surrogate end point for kidney disease progression: an individual patient meta-analysis.

Lesley A Inker, Andrew S Levey, Kruti Pandya, Nicholas Stoycheff, Aghogho Okparavero, Tom Greene, Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)

Abstract readMeta-Analysis
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in American journal of kidney diseases : the official journal of the National Kidney Foundation, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 63 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed, 11 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

63 citing papers in PubMed, 11 syntheses or guidelines pooled it.

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  9. Assessing the Validity of Surrogate Outcomes for ESRD: A Meta-Analysis.Journal of the American Society of Nephrology : JASN · 2015
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  12. Safety and efficacy of dapagliflozin in patients with focal segmental glomerulosclerosis: a prespecified analysis of the dapagliflozin and prevention of adverse outcomes in chronic kidney disease (DAPA-CKD) trial.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2022
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  13. Phosphorus Additives and Albuminuria in Early Stages of CKD: A Randomized Controlled Trial.American journal of kidney diseases : the official journal of the National Kidney Foundation · 2017
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3 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Lesley A InkerDivision of Nephrology, Tufts Medical Center, Boston, MA. Electronic address: linker@tuftsmedicalcenter.org.
Andrew S LeveyDivision of Nephrology, Tufts Medical Center, Boston, MA.
Kruti PandyaDivision of Nephrology, Tufts Medical Center, Boston, MA.
Nicholas StoycheffDivision of Nephrology, Tufts Medical Center, Boston, MA.
Aghogho OkparaveroDivision of Nephrology, Tufts Medical Center, Boston, MA.
Tom GreeneDepartment of Medicine, University of Utah School of Medicine, Salt Lake City, UT.
Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)

Funding

Epidemiology, Clinical Trials and Outcomes Research In NephrologyT32DK007777 · NIDDK · TUFTS MEDICAL CENTER · PI SARNAK, MARK J · 1999 to 2020
$4.1M
Chronic Renal Disease-Individual Patient Meta AnalysisU01DK053869 · NIDDK · TUFTS MEDICAL CENTER · PI LEVEY, ANDREW S · 2005 to 2007
$2.5M
MDRD LONG TERM FOLLOW UP STUDYU01DK035073 · NIDDK · CLEVELAND CLINIC FOUNDATION · PI BECK, GERALD J · 1986 to 2004
$650k
NIDDK NIH HHS T32 DK007777NIDDK NIH HHS U01 DK035073NIDDK NIH HHS U01 DK053869NIDDK NIH HHS UO1 DK 053869NIDDK NIH HHS UO1 DK 35073
6 · The paper itself

Abstract

backgroundIt is controversial whether proteinuria is a valid surrogate end point for randomized trials in chronic kidney disease. STUDY

designMeta-analysis of individual patient-level data. SETTING & POPULATION: Individual patient data for 9,008 patients from 32 randomized trials evaluating 5 intervention types. SELECTION CRITERIA FOR STUDIES: Randomized controlled trials of kidney disease progression until 2007 with measurements of proteinuria both at baseline and during the first year of follow-up, with at least 1 further year of follow-up for the clinical outcome. PREDICTOR: Early change in proteinuria. OUTCOMES: Doubling of serum creatinine level, end-stage renal disease, or death.

resultsEarly decline in proteinuria was associated with lower risk of the clinical outcome (pooled HR, 0.74 per 50% reduction in proteinuria); this association was stronger at higher levels of baseline proteinuria. Pooled estimates for the proportion of treatment effect on the clinical outcome explained by early decline in proteinuria ranged from -7.0% (95%CI, -40.6% to 26.7%) to 43.9% (95%CI, 25.3% to 62.6%) across 5 intervention types. The direction of the pooled treatment effects on early change in proteinuria agreed with the direction of the treatment effect on the clinical outcome for all 5 intervention types, with the magnitudes of the pooled treatment effects on the 2 end points agreeing for 4 of the 5 intervention types. The pooled treatment effects on both end points were simultaneously stronger at higher levels of proteinuria. However, statistical power was insufficient to determine whether differences in treatment effects on the clinical outcome corresponded to differences in treatment effects on proteinuria between individual studies. LIMITATIONS: Limited variety of interventions tested and low statistical power for many chronic kidney disease clinical trials.

conclusionsThese results provide new evidence supporting the use of an early reduction in proteinuria as a surrogate end point, but do not provide sufficient evidence to establish its validity in all settings.

Indexed as

Disease ProgressionEndpoint DeterminationAdultAgedComorbidityCreatinineFemaleFollow-Up StudiesHumansKidney Failure, ChronicMaleMiddle AgedProteinuriaRandomized Controlled Trials as TopicRenal Insufficiency, ChronicReproducibility of ResultsCreatininedisease trajectoryend-stage renal disease (ESRD)kidney disease progressionprognostic markerProteinuriasurrogate endpoint

Identifiers

PMID24787763
PMCPMC4070618

What OpenQuestion holds

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Registered trials

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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.