Details

Autor(en) / Beteiligte

• SHARMA, Kumar
• IX, Joachim H
• DONOHUE, Michael
• RAMACHANDRARAO, Satish
• RONGHUI XU
• FERVENZA, Fernando C
• KOPP, Jeffrey B
• MATHEW, Anna V
• CHO, Monique
• PFLUEGER, Axel
• DUNN, Stephen R
• FRANCOS, Barbara
• SHARMA, Shoba
• FALKNER, Bonita
• MCGOWAN, Tracy A

Titel

Pirfenidone for Diabetic Nephropathy

Ist Teil von

• Journal of the American Society of Nephrology, 2011-06, Vol.22 (6), p.1144-1151

Ort / Verlag

Washington, DC: American Society of Nephrology

Erscheinungsjahr

2011

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• 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.