Atrasentan in Patients with IgA Nephropathy

Patients with IgA nephropathy and severe proteinuria face a high lifetime risk of kidney failure. This phase 3 randomized controlled trial evaluated the efficacy of atrasentan, a selective endothelin type A receptor antagonist, in reducing proteinuria in adults with biopsy-confirmed IgA nephropathy. The study enrolled 340 patients, randomly assigned to receive atrasentan (0.75 mg/day) or placebo for 132 weeks.

Interim analysis of 270 patients at week 36 showed significant proteinuria reduction with atrasentan (-38.1%) compared to placebo (-3.1%, P<0.001). Safety analysis indicated no major differences in adverse events between groups. Fluid retention occurred in 11.2% of atrasentan recipients versus 8.2% in the placebo group, but did not lead to discontinuation.

The trial confirms atrasentan's potential as a disease-modifying therapy, complementing renin-angiotensin system inhibitors and other emerging treatments like SGLT2 inhibitors. Long-term efficacy analysis on kidney function decline is ongoing.

Patients with IgA nephropathy and severe proteinuria face a high lifetime risk of kidney failure. This phase 3 randomized controlled trial evaluated the efficacy of atrasentan, a selective endothelin type A receptor antagonist, in reducing proteinuria in adults with biopsy-confirmed IgA nephropathy. The study enrolled 340 patients, randomly assigned to receive atrasentan (0.75 mg/day) or placebo for 132 weeks.

Interim analysis of 270 patients at week 36 showed significant proteinuria reduction with atrasentan (-38.1%) compared to placebo (-3.1%, P<0.001). Safety analysis indicated no major differences in adverse events between groups. Fluid retention occurred in 11.2% of atrasentan recipients versus 8.2% in the placebo group, but did not lead to discontinuation.

The trial confirms atrasentan's potential as a disease-modifying therapy, complementing renin-angiotensin system inhibitors and other emerging treatments like SGLT2 inhibitors. Long-term efficacy analysis on kidney function decline is ongoing.