Journal
JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY
Volume 22, Issue 6, Pages 1144-1151Publisher
AMER SOC NEPHROLOGY
DOI: 10.1681/ASN.2010101049
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Funding
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- National Institutes of Health (NIH) [R01DK063017]
- Juvenile Diabetes Research Foundation Academic Research and Development award
- NIDDK, NIH [ZO1-DK043308]
- General Clinical Research Centers Program [M01 RR00827]
- NIH/National Center for Research Resources [1UL1 RR031980-01]
- Inter-Mune, Inc.
- Merck
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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 m(2)). 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 m(2)) whereas the mean eGFR decreased in the placebo group (-2.2 +/- 4.8 ml/min per 1.73 m(2); 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 m(2)). 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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