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Cited by 319

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Pirfenidone for Diabetic Nephropathy

Open access
Sharma, Kumar, Ix, Joachim H., Mathew, Anna V., Cho, Monique, Pflueger, Axel, Dunn, Stephen R., Francos, Barbara, Sharma, Shoba, Falkner, Bonita, McGowan, Tracy A., Donohue, Michael, RamachandraRao, Satish, Xu, Ronghui, Fervenza, Fernando C., Kopp, Jeffrey B.·2011·Journal of the American Society of Nephrology

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.

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Metadata

Authors
Sharma, K., Ix, J. H., Mathew, A. V., Cho, M., Pflueger, A., Dunn, S. R., Francos, B., Sharma, S., Falkner, B., McGowan, T. A., Donohue, M., RamachandraRao, S., Xu, R., Fervenza, F. C., & Kopp, J. B.
Venue
Journal of the American Society of Nephrology
Published
2011-06
Volume
22
Issue
6
Pages
1144-1151
ISSN
1046-6673 (ISSN-L)
OpenAlex
W2171324990
Cited by
319
References
5
FWCI
18.64
Type
journal article
Language
en
Open access
green

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CoChat. (2026). Citation check: Pirfenidone for Diabetic Nephropathy. https://app.cochat.ai/papers/10.1681/asn.2010101049
The paper
Sharma, K., Ix, J. H., Mathew, A. V., Cho, M., Pflueger, A., Dunn, S. R., Francos, B., Sharma, S., Falkner, B., McGowan, T. A., Donohue, M., RamachandraRao, S., Xu, R., Fervenza, F. C., & Kopp, J. B. (2011). Pirfenidone for Diabetic Nephropathy. Journal of the American Society of Nephrology. https://doi.org/10.1681/asn.2010101049

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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