NCT06676579

Avacopan in Crescentic Immunoglobulin A Nephropathy (IgAN)

A Multi-Center, Phase II, Open Label, Randomized Trial Evaluating the Efficacy and Safety of Complement 5a Receptor Antagonist Avacopan in Crescentic IgA Nephropathy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Avacopan together with low-dose glucocorticoid in the treatment of patients with crescentic Imunoglobulin A Nephropathy (IgAN) and high risk of progression.

Conditions

• IgA Nephropathy (IgAN)

Interventions

Type	Name	Description
DRUG	Avacopan	Avacopan is a complement 5a receptor (C5aR) antagonist, orally active.
DRUG	Prednisone	0.4 mg/kg per day (maximum, 32 mg/day) for 2 months followed by dose tapering by 4 mg per day each month (total duration 6-9 months
DRUG	Methylprednisolone (drug)	Methylprednisolone 1g intravenous on day +1
DRUG	Prednisolone	Prednisone 0.2 mg/kg per day (maximum, 16 mg/day) for 2 months followed by dose tapering by 2 mg per day each month (total duration 6-9 months)

Timeline

• Start date: 2025-06-09
• Primary completion: 2028-03-02
• Completion: 2029-03-02
• First posted: 2024-11-06
• Last updated: 2025-10-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study