Evidence map›Paper›PMID 29270487›Full record

ArticleKidney international reports2017

A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis.

Flavio Vincenti, Fernando C Fervenza, Kirk N Campbell, Montserrat Diaz, Loreto Gesualdo, Peter Nelson, Manuel Praga, Jai Radhakrishnan, Lorenz Sellin, Ajay Singh and 9 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Kidney international reports, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01665391 (A Phase 2, Multicenter, Double-Blind, Parallel Dosing, Randomized Study of Fresolimumab or Placebo in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis), which is not on this map. Cited by 95 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
95citing papers in PubMed, 2 pooled it
6.6field-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.

NCT01665391 phase2completednot on this map

A Phase 2, Multicenter, Double-Blind, Parallel Dosing, Randomized Study of Fresolimumab or Placebo in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis

TypeinterventionalSponsorGenzyme, a Sanofi CompanyRan2012 to 2014Enrolled36ConditionsPrimary Focal Segmental GlomerulosclerosisArmsfresolimumab, Placebo
3 · Its place in the literature

Who cites it

95 citing papers in PubMed, 2 syntheses or guidelines pooled it, 131 citations in OpenAlex.

  1. Pooled it
  2. Interventions for focal segmental glomerulosclerosis in adults.The Cochrane database of systematic reviews · 2022
    Pooled it
  3. Proteinuria Reduction and Kidney Survival in Focal Segmental Glomerulosclerosis.American journal of kidney diseases : the official journal of the National Kidney Foundation · 2021
    Trial
  4. Trial
  5. Review
  6. Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Rapid selection of high-affinity DARPins using click display.Protein engineering, design & selection : PEDS · 2026
    Article
  12. Review
  13. Review
  14. Review
  15. Review
  16. Article
  17. Review
  18. Review
  19. Inhibition of eCIRP attenuates PANoptosis and renal fibrosis.American journal of physiology. Renal physiology · 2025
    Article
  20. Mechanisms underlying atrial fibrillation in chronic kidney disease.Journal of molecular and cellular cardiology · 2025
    Review

35 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

19 authors at 14 institutions in 5 countries.

Flavio VincentiUniversity of California, San Francisco, San Francisco, California, USA.
Fernando C FervenzaMayo Clinic, Rochester, Minnesota, USA.
Kirk N CampbellIcahn School of Medicine at Mount Sinai, New York, New York, USA.
Montserrat DiazFundació Puigvert, Barcelona, Spain.
Loreto GesualdoAzienda Ospedaliero-Universitaria Consorziale Policlinico di Bari, U.O.C Nefrologia, Dialisi e Trapianto, Bari, Italy.
Peter NelsonUniversity of Washington, Seattle, Washington, USA.
Manuel PragaComplutense University, Investigation Institute Hospital 12 de Octubre, Madrid, Spain.
Jai RadhakrishnanColumbia University Medical Center, New York, New York, USA.
Lorenz SellinKlinik für Nephrologie, Universitätsklinikum Düsseldorf, Medical School, Düsseldorf, Germany.
Ajay SinghBrigham and Women's Hospital, Boston, Massachusetts, USA.
Denyse Thornley-BrownUniversity of Alabama at Birmingham, Alabama, USA.
Francisco Veríssimo VeroneseHospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Beverly AccomandoSanofi, Cambridge, Massachusetts, USA.
Sara EngstrandSanofi, Cambridge, Massachusetts is the former affiliation of SE, SL, JL, and JN.
Steven LedbetterSanofi, Cambridge, Massachusetts is the former affiliation of SE, SL, JL, and JN.
Julie LinSanofi, Cambridge, Massachusetts is the former affiliation of SE, SL, JL, and JN.
John NeylanSanofi, Cambridge, Massachusetts is the former affiliation of SE, SL, JL, and JN.
James TumlinUniversity of Tennessee College of Medicine, Chattanooga, Tennessee, USA.
Focal Segmental Glomerulosclerosis Study Group
Sanofi (United States) · USAzienda Universitaria Ospedaliera Consorziale - Policlinico Bari · ITBrigham and Women's Hospital · USColumbia University Irving Medical Center · USHeinrich Heine University Düsseldorf · DEHospital de Clínicas de Porto Alegre · BRIcahn School of Medicine at Mount Sinai · USMayo Clinic · USPuigvert Foundation · ESResearch Institute Hospital 12 de Octubre · ESUniversity of Alabama at Birmingham · USUniversity of California, San Francisco · USUniversity of Tennessee at Chattanooga · USUniversity of Washington · US

Funding

Research BaseP30DK063720 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI KRUMMEL, MATTHEW F · 2003 to 2019
$21.8M
NIDDK NIH HHS P30 DK063720
6 · The paper itself

Abstract

introductionSteroid-resistant focal segmental glomerulosclerosis (SR-FSGS) is a common glomerulopathy associated with nephrotic range proteinuria. Treatment goals are reduction in proteinuria, which can delay end-stage renal disease.

methodsPatients with SR-FSGS were enrolled in a randomized, double-blind placebo-controlled trial of fresolimumab, a monoclonal anti-transforming growth factor-β antibody, at 1 mg/kg or 4 mg/kg for 112 days, followed double-blind for 252 days (NCT01665391). The primary efficacy endpoint was the percentage of patients achieving partial (50% reduction) or complete (< 300 mg/g Cr) remission of proteinuria.

resultsOf 36 enrolled patients, 10, 14, and 12 patients received placebo, fresolimumab 1 mg/kg, and fresolimumab 4 mg/kg, respectively. The baseline estimated glomerular filtration rate (eGFR) and urinary protein/creatinine ratio were 63 ml/min/1.73 m DISCUSSION: The study was underpowered and did not meet the primary or secondary endpoints. However, fresolimumab was well tolerated and is appropriate for continued evaluation in larger studies with adequate power.

Indexed as

fresolimumabmonoclonal antibodyproteinuriasteroid-resistant primary focal segmental glomerulosclerosis

Identifiers

PMID29270487
PMCPMC5733825
OpenAlexW2604135869

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.