Clinical Trial: A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome - CARDINAL

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome

Brief Summary: This international, multi-center, Phase 2/3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with Alport syndrome. The Phase 2 portion of the trial will be open-label and enroll up to 30 patients. The Phase 3 portion of the trial will be double-blind, randomized, placebo-controlled and will enroll up to 180 patients.

Detailed Summary:

This international, multi-center, Phase 2/3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with Alport syndrome. The Phase 2 portion of the trial will be open-label and enroll up to 30 patients. The Phase 3 portion of the trial will be double-blind, randomized, placebo-controlled and will enroll up to 180 patients.

Patients in the Phase 2 cohort will receive bardoxolone methyl throughout the study. Patients in the Phase 3 cohort will be randomized 1:1 to either bardoxolone methyl or placebo and randomization will be stratified by baseline albumin to creatinine ratio (ACR). Patients randomized to placebo will remain on placebo throughout the study, undergoing sham titration.

All patients in the study will follow the same visit and assessment schedule. Following randomization on Day 1, patients will be scheduled to be assessed during treatment at Weeks 1, 2, 4, 6, 8, 12, 24, 36, 48, 52, 64, 76, 88, 100, and 104 and by telephone contact on Days 3, 10, 21, 31, 38, and 45. Patients will not receive study drug during a 4-week withdrawal period between Weeks 48 and 52. They will re-start treatment at Week 52 at the same dose they received at Week 48 and will continue study drug treatment through Week 100. Patients will also be scheduled to be assessed at an in person follow up visit at Week 104, four weeks after the end of treatment.


Sponsor: Reata Pharmaceuticals, Inc.

Current Primary Outcome: Increase in eGFR from baseline [ Time Frame: 48 weeks ]

To assess the increase in eGFR from baseline to week 12 (Phase 2) or week 48 (Phase 3) for patients receiving active drug, compared to patients receiving placebo.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Increase in eGFR from baseline following a 4-week drug treatment withdrawal period [ Time Frame: 52 weeks ]
    To assess the change from baseline in eGFR in bardoxolone methyl-treated patients at Week 52 following a 4-week drug treatment withdrawal period.
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 100 weeks ]
    Safety will be assessed by monitoring adverse events, physical examinations and clinical laboratory test through 100 weeks.


Original Secondary Outcome: Same as current

Information By: Reata Pharmaceuticals, Inc.

Dates:
Date Received: January 6, 2017
Date Started: March 2, 2017
Date Completion: January 2020
Last Updated: May 15, 2017
Last Verified: May 2017