NCT03366337

A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIX

A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This multi-center, open-label Phase 2 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with the following rare chronic kidney diseases (CKD): CKD associated with type 1 diabetes (T1D), IgA nephropathy (IgAN), focal segmental glomerulosclerosis (FSGS), and autosomal dominant polycystic kidney disease (ADPKD). Patients will be enrolled in disease specific cohorts within the trial, and effectiveness of bardoxolone methyl in treating CKD will be assessed separately by cohort for each rare CKD. 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, and 12, and by telephone contact on Days 3, 10, 21, 31, 38, and 45. Patients will also be scheduled to be assessed at an in-person follow-up visit at Week 16, four weeks after the end of treatment.

Conditions

• IgA Nephropathy
• CKD Associated With Type 1 Diabetes
• Focal Segmental Glomerulosclerosis
• Autosomal Dominant Polycystic Kidney

Interventions

Type	Name	Description
DRUG	Bardoxolone methyl capsules	Bardoxolone 5 mg capsules

Timeline

• Start date: 2017-12-26
• Primary completion: 2019-01-02
• Completion: 2019-01-29
• First posted: 2017-12-08
• Last updated: 2025-06-03
• Results posted: 2022-01-18

Locations

30 sites across 1 country: United States

Regulatory

• FDA-regulated drug study