Avacopan in Crescentic Immunoglobulin A Nephropathy (IgAN)
NCT06676579 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2025-10-03
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
- DRUG
-
Avacopan
Avacopan is a complement 5a receptor (C5aR) antagonist, orally active.
- DRUG
-
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)
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Fernando Fervenza, MD · Mayo Clinic, Rochester, MN
-
Nabeel Aslam, MD · Mayo Clinic
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-09
- Primary Completion
- 2028-03-02
- Completion
- 2029-03-02
- FDA Drug
- Yes
Countries
- United States
Study Locations
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