Evidence map›Paper›PMID 33775708›Full record

SynthesisAmerican journal of kidney diseases : the official journal of the National Kidney Foundation2021

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

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 and 7 more

Registry-linked trialOpen access · bronzeAbstract readMeta-AnalysisReview
In one paragraph

Synthesis in American journal of kidney diseases : the official journal of the National Kidney Foundation, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07667517 (Efficacy and Safety of Finerenone for the Early Regression of Albuminuria in Patients With Type 2 Diabetes Mellitus and Chronic Kidney Disease), which is not on this map. Cited by 52 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed, 6 pooled it
7.6field-weighted citation impact, top 2% of its field
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.

NCT07667517 phase4not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Efficacy and Safety of Finerenone for the Early Regression of Albuminuria in Patients With Type 2 Diabetes Mellitus and Chronic Kidney Disease: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

TypeinterventionalSponsorFirst Affiliated Hospital of Zhejiang UniversityRan2026 to 2027Enrolled148ConditionsAlbuminuria, Type 2 Diabetes Mellitus (T2DM), Chronic Kidney DiseasesArmsFinerenone (BAY 94-8862), Placebo
3 · Its place in the literature

Who cites it

52 citing papers in PubMed, 6 syntheses or guidelines pooled it, 91 citations in OpenAlex.

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  11. Recommendations for pre-analytical urine sample handling to allow optimal assessment of albuminuria and proteinuria.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 12 institutions in 7 countries.

Lesley A InkerDivision of Nephrology, Tufts Medical Center, Boston, MA. Electronic address: linker@tuftsmedicalcenter.org.
Hiddo J L HeerspinkDepartment of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Hocine TighiouartInstitute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA; Tufts Clinical and Translational Science Institute, Tufts University, Boston, MA.
Juhi ChaudhariDivision of Nephrology, Tufts Medical Center, Boston, MA.
Shiyuan MiaoDivision of Nephrology, Tufts Medical Center, Boston, MA.
Ulysses DivaBiometrics, Travere Therapeutics Inc, San Diego, CA.
Alex MercerClinical Drug Development, JAMCO Pharma Consulting AB, Stockholm, Sweden.
Gerald B AppelDivision of Nephrology, Columbia University Medical Center and the New York Presbyterian Hospital, New York, NY.
James V DonadioEmeritus Staff, Mayo Clinic, Rochester, MN.
Jürgen FloegeDivision of Nephrology and Immunology, RWTH Aachen University, Aachen, Germany.
Philip K T LiDivision of Nephrology, Prince of Wales Hospital, Chinese University of Hong Kong, Shatin, Hong Kong.
Bart D MaesDepartment of Nephrology, AZ Delta, Roeselare, Belgium.
Francesco LocatelliDepartment of Nephrology and Dialysis, Alessandro Manzoni Hospital, Lecco.
Manuel PragaInstituto de Investigación Hospital Universitario 12 de Octubre, i+12, Complutense University, Madrid, Spain.
Francesco P SchenaRenal, Dialysis and Transplant Unit, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy.
Andrew S LeveyDivision of Nephrology, Tufts Medical Center, Boston, MA.
Tom GreeneDepartments of Population Health Sciences and Internal Medicine, University of Utah, Salt Lake City, UT.
Tufts Medical Center · USAlessandro Manzoni Hospital · ITAZ Delta · BEChinese University of Hong Kong · CNHospital Universitario 12 De Octubre · ESMayo Clinic · USNewYork–Presbyterian Hospital · USRWTH Aachen University · DETherapeutics Clinical Research · USUniversity Medical Center Groningen · NLUniversity of Bari Aldo Moro · ITUniversity of Utah · US

Funding

Tufts Clinical and Translational Science Institute (Pilot Supplement)UL1TR002544 · NCATS · TUFTS UNIVERSITY BOSTON · PI SELKER, HARRY P. · 2018 to 2022
$50.2M
Utah Center for Clinical and Translational ScienceUL1TR002538 · NCATS · UNIVERSITY OF UTAH · PI HESS, RACHEL, MAJERSIK, JENNIFER JUHL · 2018 to 2022
$26.0M
NCATS NIH HHS UL1 TR002538NCATS NIH HHS UL1 TR002544
6 · The paper itself

Abstract

RATIONALE &

objectiveAn early change in proteinuria is considered a reasonably likely surrogate end point in immunoglobulin A nephropathy (IgAN) and can be used as a basis for accelerated approval of therapies, with verification in a postmarketing confirmatory trial. Glomerular filtration rate (GFR) slope is a recently validated surrogate end point for chronic kidney disease progression and may be considered as the end point used for verification. We undertook a meta-analysis of clinical trials in IgAN to compare treatment effects on change in proteinuria versus change in estimated GFR (eGFR) slope. STUDY

designIndividual patient-level meta-analysis. SETTING & STUDY POPULATIONS: Individual data of 1,037 patients from 12 randomized trials. SELECTION CRITERIA FOR STUDIES: Randomized trials of IgAN with proteinuria measurements at baseline and 6 (range, 2.5-14) months and at least a further 1 year of follow-up for the clinical outcome. ANALYTICAL APPROACH: For each trial, we estimated the treatment effects on proteinuria and on the eGFR slope, computed as the total slope starting at baseline or the chronic slope starting 3 months after randomization. We used a Bayesian mixed-effects analysis to relate the treatment effects on proteinuria to effects on GFR slope across these studies and developed a prediction model for the treatment effect on the GFR slope based on the effect on proteinuria.

resultsAcross all studies, treatment effects on proteinuria accurately predicted treatment effects on the total slope at 3 years (median R LIMITATIONS: Study population restricted to 12 trials of small sample size, leading to wide BCIs. There was heterogeneity among trials with respect to study design and interventions.

conclusionsThese results provide new evidence supporting that early reduction in proteinuria can be used as a surrogate end point for studies of chronic kidney disease progression in IgAN.

Indexed as

Disease ManagementBayes TheoremCreatinineDisease ProgressionGlomerular Filtration RateGlomerulonephritis, IGAHumansResearch DesignUrinalysisCreatinineend-stage renal disease (ESRD)GFR slopeGlomerular filtration rate (GFR)IgA nephropathy (IgAN)kidney disease progressionmeta-analysisproteinuriaregulatory approvalrenal functionsurrogate end pointtreatment effecttrial designurine protein

Identifiers

PMID33775708
PMCPMC8384669
OpenAlexW3136511580

What OpenQuestion holds

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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.