Evidence map›Paper›PMID 39455047›Full record

ReviewAmerican journal of kidney diseases : the official journal of the National Kidney Foundation2025

Proteinuria as an End Point in Clinical Trials of Focal Segmental Glomerulosclerosis.

Laura H Mariani, Howard Trachtman, Aliza Thompson, Barbara S Gillespie, Michelle Denburg, Ulysses Diva, Duvuru Geetha, Peter J Greasley, Michelle A Hladunewich, Robert B Huizinga and 8 more

Abstract readReview
In one paragraph

Review in American journal of kidney diseases : the official journal of the National Kidney Foundation, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

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

3 citing papers in PubMed.

  1. Article
  2. Albuminuria Changes as a surrogate endpoint inmedRxiv : the preprint server for health sciences · 2026
    Article
  3. Treatment Response Rates and Kidney Outcomes among Adults with Primary FSGS.Clinical journal of the American Society of Nephrology : CJASN · 2026
    Article
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

18 authors.

Laura H MarianiRenal Division, University of Michigan, Ann Arbor, Michigan. Electronic address: lmariani@umich.edu.
Howard TrachtmanDepartment of Pediatrics/Nephrology, University of Michigan, Ann Arbor, Michigan. Electronic address: howardtrachtman21@gmail.com.
Aliza ThompsonCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
Barbara S GillespieFortrea, Durham, North Carolina; Kidney Center, University of North Carolina, Chapel Hill, North Carolina.
Michelle DenburgChildren's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
Ulysses DivaTravere Therapeutics, San Diego, California.
Duvuru GeethaSchool of Medicine, Johns Hopkins University, Baltimore, Maryland.
Peter J GreasleyResearch and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Michelle A HladunewichUniversity of Toronto, Toronto, Ontario.
Robert B HuizingaAurinia Pharmaceuticals, Victoria, British Columbia, Canada.
Jula K InrigTravere Therapeutics, San Diego, California.
Radko KomersTravere Therapeutics, San Diego, California.
Louis-Philippe LaurinDivision of Nephrology, Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada.
Dustin J LittleClinical Development, Late Cardiovascular, Renal and Metabolism, AstraZeneca, Gaithersburg, Maryland.
Patrick H NachmanUniversity of Minnesota, Minneapolis, Minnesota.
Kimberly A SmithCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
Liron WalshGoldfinch Bio, Boston, Massachusetts.
Keisha L GibsonKidney Center, University of North Carolina, Chapel Hill, North Carolina.

Funding

Kidney Health Initiative is a public-private partnership between the American Society of Nephrology, US Food and Drug Administration and the kidney community.R18FD005283 · FDA · AMERICAN SOCIETY OF NEPHROLOGY, INC. · PI IBRAHIM, TOD RAMSES · 2014 to 2025
$4.3M
FDA HHS R18 FD005283
6 · The paper itself

Abstract

Focal segmental glomerulosclerosis (FSGS) is a characteristic histopathological lesion that is indicative of underlying glomerular dysfunction. It is not a single disease entity but rather a heterogeneous disorder that is an important cause of nephrotic syndrome and kidney failure in children and adults. The aim of this Kidney Health Initiative project was to evaluate potential end points for clinical trials in FSGS. Our focus is on the data supporting proteinuria as a surrogate end point. Available data support the use of complete remission of proteinuria in patients with heavy proteinuria as a surrogate end point for progression to kidney failure. Substantial treatment effects on proteinuria that are short of a complete remission may also predict the effect of a treatment on progression to kidney failure, but further work is needed to determine how such an end point should be defined. Fortunately, efforts are underway to bring together patient-level data from randomized controlled trials, observational studies, and registries to address this issue.

Indexed as

Clinical Trials as TopicEndpoint DeterminationGlomerulosclerosis, Focal SegmentalProteinuriaDisease ProgressionHumansClinical trialsfocal segmental glomerulosclerosis (FSGS)proteinuriasurrogate end points

Identifiers

PMID39455047
PMCPMC12014854

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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 Socratic graph.