Evidence map›Paper›PMID 21178977›Full record

Trial reportKidney international2011

Clinical trials treating focal segmental glomerulosclerosis should measure patient quality of life.

Debbie S Gipson, Howard Trachtman, Frederick J Kaskel, Milena K Radeva, Jennifer Gassman, Tom H Greene, Marva M Moxey-Mims, Ronald J Hogg, Sandra L Watkins, Richard N Fine and 9 more

Open access · bronzeAbstract readComparative StudyMulticenter 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 45 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 7 pooled it
2.1field-weighted citation impact, top 14% 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

45 citing papers in PubMed, 7 syntheses or guidelines pooled it, 61 citations in OpenAlex.

  1. Pooled it
  2. Corticosteroid therapy for nephrotic syndrome in children.The Cochrane database of systematic reviews · 2024
    Pooled it
  3. Interventions for focal segmental glomerulosclerosis in adults.The Cochrane database of systematic reviews · 2022
    Pooled it
  4. Corticosteroid therapy for nephrotic syndrome in children.The Cochrane database of systematic reviews · 2020
    Pooled it
  5. Pooled it
  6. Pooled it
  7. Corticosteroid therapy for nephrotic syndrome in children.The Cochrane database of systematic reviews · 2015
    Pooled it
  8. Trial
  9. Association of histologic variants in FSGS clinical trial with presenting features and outcomes.Clinical journal of the American Society of Nephrology : CJASN · 2013
    Trial
  10. Renal function and proteinuria after successful immunosuppressive therapies in patients with FSGS.Clinical journal of the American Society of Nephrology : CJASN · 2013
    Trial
  11. Trial
  12. Review
  13. Article
  14. Article
  15. Article
  16. Review
  17. Review
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  20. 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

19 authors at 13 institutions in 1 country.

Debbie S GipsonUniversity of Michigan, Pediatrics & Communicable Diseases, Pediatric Nephrology, Ann Arbor, Michigan, USA. Electronic address: dgipson@umich.edu.
Howard TrachtmanDivision of Nephrology, Department of Pediatrics, Cohen Children's Hospital, New York, New York, USA.
Frederick J KaskelMontefiore Medical Center, Children's Hospital, Pediatric Nephrology, New York, New York, USA.
Milena K RadevaCleveland Clinic, Department of Quantitative Health Sciences, Cleveland, Ohio, USA.
Jennifer GassmanCleveland Clinic, Department of Quantitative Health Sciences, Cleveland, Ohio, USA.
Tom H GreeneDivision of Epidemiology, University of Utah, Salt Lake City, Utah, USA.
Marva M Moxey-MimsNIH/NIDDK, Division of Kidney, Urology & Hematology, Bethesda, Maryland, USA.
Ronald J HoggThe Children's Hospital at Scott & White Medical Center, Department of Pediatrics, Temple, Texas, USA.
Sandra L WatkinsDivision of Nephrology, Department of Pediatrics, University of Washington, Seattle, Washington, USA.
Richard N FineStony Brook University Medical Center, School of Medicine, Stony Brook, New York, USA.
John P MiddletonDivision of Nephrology, Department of Medicine, Duke University, Durham, North Carolina, USA.
V M VehaskariLouisiana State University Health Sciences Center and the Research Institute for Children, Children's Hospital & LSU Health Sciences Center, New Orleans, Louisiana, USA.
Susan L HoganDivision of Nephrology & Hypertension at Chapel Hill, UNC Kidney Center, University of North Carolina, Chapel Hill, North Carolina, USA.
Suzzane VentoDivision of Nephrology, Department of Pediatrics, Cohen Children's Hospital, New York, New York, USA.
Patti A FlynnMontefiore Medical Center, Children's Hospital, Pediatric Nephrology, New York, New York, USA.
Leslie M PowellDivision of Nephrology & Hypertension at Chapel Hill, UNC Kidney Center, University of North Carolina, Chapel Hill, North Carolina, USA.
June L McMahanCleveland Clinic, Department of Quantitative Health Sciences, Cleveland, Ohio, USA.
Norman Siegel
Aaron L FriedmanDepartment of Pediatrics, University of Minnesota, Minneapolis, Minnesota, USA.
Cleveland Clinic · USCohen Children's Medical Center · USUniversity of North Carolina at Chapel Hill · USYeshiva University · USBaylor Scott & White Medical Center - Temple · USChildren's Hospital of New Orleans · USDuke University · 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 U01 DK063385NIDDK NIH HHS U01-DK063385NIDDK NIH HHS U01 DK063455NIDDK NIH HHS U01-DK063455NIDDK NIH HHS U01 DK063490NIDDK NIH HHS U01-DK063490NIDDK NIH HHS U01 DK063549NIDDK NIH HHS U01-DK063549
6 · The paper itself

Abstract

Optimal therapy of patients with steroid-resistant primary focal segmental glomerulosclerosis (FSGS) remains controversial. This report describes the initial study design, baseline characteristics, and quality of life of patients enrolled in the FSGS Clinical Trial, a large multicenter randomized study of this glomerulopathy comparing a 12-month regimen of cyclosporine to the combination of mycophenolate mofetil and oral dexamethasone. Patients with age ranging 2-40 years, with an estimated glomerular filtration rate > 40 ml/min per 1.73 m², a first morning urine protein-to-creatinine ratio over one, and resistant to corticosteroids were eligible. The primary outcome was complete or partial remission of proteinuria over 52 weeks after randomization. In all, 192 patients were screened, of whom 138 were randomized for treatment. Ethnic distributions were 53 black, 78 white, and 7 other. By self- or parent-proxy reporting, 26 of the 138 patients were identified as Hispanic. The baseline glomerular filtration rate was 112.4 (76.5, 180.0) ml/min per 1.73 m², and urine protein was 4.0 (2.1, 5.3) g/g. Overall, the quality of life of the patients with FSGS was lower than healthy controls and similar to that of patients with end-stage renal disease. Thus, the impact of FSGS on quality of life is significant and this measurement should be included in all trials.

Indexed as

Quality of LifeAdministration, OralAdolescentAdultChildChild, PreschoolChi-Square DistributionDexamethasoneDrug ResistanceDrug Therapy, CombinationFemaleGlomerular Filtration RateGlomerulosclerosis, Focal SegmentalHumansImmunosuppressive AgentsMaleDexamethasoneImmunosuppressive AgentsMycophenolic Acid

Identifiers

PMID21178977
PMCPMC3306823
OpenAlexW1972855150

What OpenQuestion 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 OpenQuestion graph.