Evidence map›Paper›PMID 40493692›Full record

SynthesisPloS one2025

Clinical study outcomes in IgA nephropathy: A systematic literature review and narrative synthesis.

Anushya Jeyabalan, Kenar D Jhaveri, Martin Bunke, Jonathon A Briggs, David M W Cork, Mark E Bensink

2 registry-linked trialsAbstract readSystematic Review
In one paragraph

Synthesis in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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.

NCT03643965 phase3completednot on this map

A Randomized, Double-blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy at Risk of Progressing to End-stage Renal Disease (NefIgArd)

TypeinterventionalSponsorCalliditas Therapeutics ABRan2018 to 2023Enrolled365ConditionsPrimary IgA NephropathyArmsNefecon, Placebo oral capsule
NCT03762850 phase3active not recruitingnot on this map

A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy

TypeinterventionalSponsorTravere Therapeutics, Inc.Ran2018 to 2026Enrolled406ConditionsImmunoglobulin A NephropathyArmssparsentan, irbesartan, Dapagliflozin
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Review
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

6 authors.

Anushya JeyabalanVasculitis & Glomerulonephritis Center, Massachusetts General Hospital, Boston, Massachusetts, United States of America.ORCID https://orcid.org/0000-0003-1959-0250
Kenar D JhaveriGlomerular Center at Northwell Health, Division of Kidney Diseases and Hypertension and Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Great Neck, New York, United States of America.
Martin BunkeC M Bunke Consulting, Mt Pleasant, South Carolina, United States of America.
Jonathon A BriggsGenesis Research, Newcastle upon Tyne, United Kingdom.
David M W CorkGenesis Research, Newcastle upon Tyne, United Kingdom.
Mark E BensinkTravere Therapeutics, Inc., San Diego, California, United States of America.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIgA nephropathy (IgAN) is an inflammatory kidney disease which, if left untreated, often progresses to kidney failure (KF). This systematic literature review identifies, collates, summarizes, and assesses the quality of clinical trial data describing the efficacy of therapies used for IgAN.

methodsOvid Embase, PubMed, CENTRAL, and the Cochrane database of systematic reviews were searched on October 18th, 2021, and updated on December 12th, 2023. Electronic searches were supplemented with manual searches of key conferences, clinical trial registries, and bibliography screening. PRISMA and Cochrane guidelines were followed.

resultsA total of 6710 references were identified (electronic and manual searches), of which 6483 were excluded. This resulted in 254 references reporting 183 studies which met our inclusion criteria. The majority of these IgAN studies (98/183 studies [60%]) had a non-randomized or single-arm design and/or a small population size or focused on dietary and traditional medicine, resulting in a high risk of bias and necessitated additional filtering to prioritize larger (n>30) randomized assessment of pharmacological interventions reporting key clinical outcomes. This additional filtering resulted in 76 randomized controlled trials (100 references) selected for narrative synthesis; 60 reported proteinuria outcomes and 18 reported estimated glomerular filtration rate (eGFR) outcomes.

conclusionsUntil recently, the evidence has been mixed or inconsistent across studies for the efficacy of IgAN treatments in reducing proteinuria or slowing eGFR decline due to a high risk of bias in many included studies. The latest large, phase 3 NefIgArd (NCT03643965) and PROTECT (NCT03762850) clinical trials have demonstrated a meaningful reduction in proteinuria and eGFR decline for patients with IgAN receiving targeted-release formulation budesonide (TRF-B) or sparsentan. Results from other high-quality randomized controlled trials with a follow-up period of at least 2 years are still required to better support advancements in the management of IgAN.

Indexed as

Glomerulonephritis, IGAHumansRandomized Controlled Trials as TopicTreatment Outcome

Identifiers

PMID40493692
PMCPMC12151485

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.