Evidence map›Paper›PMID 21511828›Full record

Trial reportJournal of the American Society of Nephrology : JASN2011

Pirfenidone for diabetic nephropathy.

Kumar Sharma, Joachim H Ix, Anna V Mathew, Monique Cho, Axel Pflueger, Stephen R Dunn, Barbara Francos, Shoba Sharma, Bonita Falkner, Tracy A McGowan and 5 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American Society of Nephrology : JASN, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04258397 (Trial of Pirfenidone to Prevent Progression in Chronic Kidney Disease), which is not on this map. Cited by 161 papers.

0numbers the graph read from it
0cells of the map it votes in
161citing papers in PubMed
21.2field-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.

NCT04258397 phase2unknown statusnot on this mapstarted 2020, after this paper: background citation

Trial of Pirfenidone to Prevent Progression in Chronic Kidney Disease (TOP-CKD)

TypeinterventionalSponsorVeterans Medical Research FoundationRan2020 to 2024Enrolled200ConditionsChronic Kidney DiseaseArmsPirfenidone, matching placebo
3 · Its place in the literature

Who cites it

161 citing papers in PubMed, 308 citations in OpenAlex.

  1. Anti-TGF-Journal of the American Society of Nephrology : JASN · 2017
    Trial
  2. Trial
  3. Article
  4. Macrophage-Fibroblast Crosstalk in Kidney Injury: A Narrative Review.International journal of molecular sciences · 2026
    Review
  5. Review
  6. Article
  7. Review
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. Review
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  17. Review
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  20. Article

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 8 institutions in 1 country.

Kumar SharmaCenter for Renal Translational Medicine, University of California-San Diego/Veteran Affairs Medical Center, La Jolla, CA 92093-0711, USA. kumarsharma@ucsd.edu
Joachim H Ix
Anna V Mathew
Monique Cho
Axel Pflueger
Stephen R Dunn
Barbara Francos
Shoba Sharma
Bonita Falkner
Tracy A McGowan
Michael Donohue
Satish Ramachandrarao
Ronghui Xu
Fernando C Fervenza
Jeffrey B Kopp
University of California, San Diego · USMayo Clinic · USNational Institute of Diabetes and Digestive and Kidney Diseases · USThomas Jefferson University · USVA San Diego Healthcare System · USJohnson & Johnson (United States) · USPediatric Nephrology of Alabama · USSidney Kimmel Cancer Center · US

Funding

ZOVIRAX CREAM TO TREAT HERPES LABIALIS IN ADOLESCENTSM01RR000827 · NCRR · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI CHANG, R JEFFREY · 1985 to 2010
$74.3M
SAN DIEGO CLINICAL AND TRANSLATIONAL RESEARCH INSTITUTEUL1RR031980 · NCRR · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI FIRESTEIN, GARY S · 2010 to 2011
$14.0M
Focal segmental glomerulosclerosis: TreatmentZIADK043412 · NIDDK · NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES · PI KOPP, JEFFREY BURNETT · 2009 to 2024
$7.4M
Pirfenidone: Anti-Scarring Drug for Diabetic NephropathyR01DK063017 · NIDDK · UNIVERSITY OF CALIFORNIA SAN DIEGO · PI SHARMA, KUMAR · 2002 to 2005
$1.5M
FOCAL SEGMENTAL GLOMERULOSCLEROSIS--PATHOGENESIS AND TREATMENTZ01DK043308 · NIDDK · NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES · PI KOPP, JEFFREY BURNETT · 1997 to 2008
$1.0M
Podocyte diseases: Pathogenesis and novel therapiesZIADK075029 · NIDDK · NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES · PI CHO, MONIQUE · 2009 to 2010
$889k
Comprehensive live kidney donor monitoringZIADK075026 · NIDDK · NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES · PI CHO, MONIQUE · 2009 to 2013
$379k
Intramural NIH HHS Z01 DK043308NCRR NIH HHS M01 RR000827NCRR NIH HHS UL1 RR031980NIDDK NIH HHS R01 DK063017
6 · The paper itself

Abstract

Pirfenidone is an oral antifibrotic agent that benefits diabetic nephropathy in animal models, but whether it is effective for human diabetic nephropathy is unknown. We conducted a randomized, double-blind, placebo-controlled study in 77 subjects with diabetic nephropathy who had elevated albuminuria and reduced estimated GFR (eGFR) (20 to 75 ml/min per 1.73 m²). The prespecified primary outcome was a change in eGFR after 1 year of therapy. We randomly assigned 26 subjects to placebo, 26 to pirfenidone at 1200 mg/d, and 25 to pirfenidone at 2400 mg/d. Among the 52 subjects who completed the study, the mean eGFR increased in the pirfenidone 1200-mg/d group (+3.3 ± 8.5 ml/min per 1.73 m²) whereas the mean eGFR decreased in the placebo group (-2.2 ± 4.8 ml/min per 1.73 m²; P = 0.026 versus pirfenidone at 1200 mg/d). The dropout rate was high (11 of 25) in the pirfenidone 2400-mg/d group, and the change in eGFR was not significantly different from placebo (-1.9 ± 6.7 ml/min per 1.73 m²). Of the 77 subjects, 4 initiated hemodialysis in the placebo group, 1 in the pirfenidone 2400-mg/d group, and none in the pirfenidone 1200-mg/d group during the study (P = 0.25). Baseline levels of plasma biomarkers of inflammation and fibrosis significantly correlated with baseline eGFR but did not predict response to therapy. In conclusion, these results suggest that pirfenidone is a promising agent for individuals with overt diabetic nephropathy.

Indexed as

Disease ProgressionAdultAgedAlbuminuriaAnti-Inflammatory Agents, Non-SteroidalBiomarkersCreatinineDiabetic NephropathiesDose-Response Relationship, DrugDouble-Blind MethodFemaleFibrosisGlomerular Filtration RateHumansKidneyMaleAnti-Inflammatory Agents, Non-SteroidalBiomarkersCreatininepirfenidonePyridones

Identifiers

PMID21511828
PMCPMC3103734
OpenAlexW2171324990

What OpenQuestion holds

Textmetadata
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.