Evidence map›Paper›PMID 21734640›Full record

Trial reportKidney international2011

Clinical trial of focal segmental glomerulosclerosis in children and young adults.

Debbie S Gipson, Howard Trachtman, Frederick J Kaskel, Tom H Greene, Milena K Radeva, Jennifer J Gassman, Marva M Moxey-Mims, Ronald J Hogg, Sandra L Watkins, Richard N Fine and 10 more

Open access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Kidney international, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 112 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
112citing papers in PubMed, 9 pooled it
11.4field-weighted citation impact, top 1% 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.

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

112 citing papers in PubMed, 9 syntheses or guidelines pooled it, 241 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Interventions for focal segmental glomerulosclerosis in adults.The Cochrane database of systematic reviews · 2022
    Pooled it
  5. Guideline
  6. Pooled it
  7. Pooled it
  8. Guideline
  9. Guideline
  10. Trial
  11. 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
    Trial
  12. Trial
  13. Proteinuria Reduction and Kidney Survival in Focal Segmental Glomerulosclerosis.American journal of kidney diseases : the official journal of the National Kidney Foundation · 2021
    Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Treatment of idiopathic FSGS with adrenocorticotropic hormone gel.Clinical journal of the American Society of Nephrology : CJASN · 2013
    Trial
  20. Association of histologic variants in FSGS clinical trial with presenting features and outcomes.Clinical journal of the American Society of Nephrology : CJASN · 2013
    Trial

52 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 14 institutions in 1 country.

Debbie S GipsonDivision of Nephrology, Department of Pediatrics & Communicable Diseases, University of Michigan, Ann Arbor, Michigan, USA. dgipson@umich.edu
Howard Trachtman
Frederick J Kaskel
Tom H Greene
Milena K Radeva
Jennifer J Gassman
Marva M Moxey-Mims
Ronald J Hogg
Sandra L Watkins
Richard N Fine
Susan L Hogan
John P Middleton
V Matti Vehaskari
Patti A Flynn
Leslie M Powell
Suzanne M Vento
June L McMahan
Norman Siegel
Vivette D D'Agati
Aaron L Friedman
Cleveland Clinic · USCohen Children's Medical Center · USUniversity of North Carolina at Chapel Hill · USYeshiva University · USBoston Children's Hospital · USColumbia University · USDuke University · USLouisiana State University Health Sciences Center New Orleans · USNational Institutes of Health · USStony Brook University Hospital · USUniversity of Michigan · USUniversity of Minnesota · USUniversity of Utah · USUniversity of Washington · US

Funding

Focal Glomerulosclerosis Trial Data Coordinating CenterU01DK063490 · NIDDK · CLEVELAND CLINIC LERNER COM-CWRU · PI GASSMAN, JENNIFER · 2002 to 2008
$5.6M
Multicenter Trial of Focal GlomerulosclerosisU01DK063455 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI GIPSON, DEBBIE S · 2002 to 2009
$2.6M
Tacrolimus vs Intensive Prednisone in Pediatric FSGSU01DK063549 · NIDDK · MONTEFIORE MEDICAL CENTER (BRONX, NY) · PI KASKEL, FREDERICK · 2002 to 2007
$2.4M
OPTIMAL TREATMENT OF FOCAL SEGMENTAL GLOMERULOSCLEROSISU01DK063385 · NIDDK · STATE UNIVERSITY NEW YORK STONY BROOK · PI FINE, RICHARD N · 2002 to 2007
$2.1M
NIDDK NIH HHS DK063455NIDDK NIH HHS DK063490NIDDK NIH HHS DK063549NIDDK NIH HHS U01 DK063385NIDDK NIH HHS U01- DK063385NIDDK NIH HHS U01 DK063455NIDDK NIH HHS U01 DK063490NIDDK NIH HHS U01 DK063549
6 · The paper itself

Abstract

This NIH-funded multicenter randomized study of focal segmental glomerulosclerosis (FSGS) treatment compared the efficacy of a 12-month course of cyclosporine to a combination of oral pulse dexamethasone and mycophenolate mofetil in children and adults with steroid-resistant primary FSGS. Of the 192 patients enrolled, 138 were randomized to cyclosporine (72) or to mycophenolate/dexamethasone (66). The primary analysis compared the levels of an ordinal variable measuring remission during the first year. The odds ratio (0.59) for achieving at least a partial remission with mycophenolate/dexamethasone compared to cyclosporine was not significant. Partial or complete remission was achieved in 22 mycophenolate/dexamethasone- and 33 cyclosporine-treated patients at 12 months. The main secondary outcome, preservation of remission for 26 weeks following cessation of treatment, was not significantly different between these two therapies. During the entire 78 weeks of study, 8 patients treated with cyclosporine and 7 with mycophenolate/dexamethasone died or developed kidney failure. Thus, our study did not find a difference in rates of proteinuria remission following 12 months of cyclosporine compared to mycophenolate/dexamethasone in patients with steroid-resistant FSGS. However, the small sample size might have prevented detection of a moderate treatment effect.

Indexed as

AdolescentAdultBlood PressureChildChild, PreschoolCyclosporineDexamethasoneDrug Therapy, CombinationFemaleGlomerular Filtration RateGlomerulosclerosis, Focal SegmentalHumansMaleMycophenolic AcidProspective StudiesYoung AdultCyclosporineDexamethasoneMycophenolic Acid

Identifiers

PMID21734640
PMCPMC3306824
OpenAlexW1977991117

What OpenQuestion holds

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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 OpenQuestion graph.