Open-Label Study to Evaluate Safety and Efficacy of CCX168 in Subjects With IGA Nephropathy on Stable RAAS Blockade

Summary

The primary safety objective of this study is to evaluate the safety and tolerability of CCX168 in subjects with IgAN on background supportive therapy with a maximally tolerated dose of RAAS blockade. The primary efficacy objective is to evaluate the efficacy of CCX168 based on an improvement in proteinuria.

Timeline

Start

2015-03-27

Primary completion

2015-09-13

Completion

2018-06-01

Outcome

Missed primary endpoint

registry analysis (superiority test); 8-week Run-in Period vs 12-week Treatment Period; p = 0.965; Slope -2.4 (95% CI -133.6 to 128.7); Random coefficients regression NCT02384317 ↗

Drugs

Indications