Actively Recruiting
Avacopan in Crescentic Immunoglobulin A Nephropathy (IgAN)
Led by Mayo Clinic · Updated on 2025-10-03
16
Participants Needed
2
Research Sites
194 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Avacopan in Crescentic Immunoglobulin A Nephropathy (IgAN)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18 years
- Kidney biopsy showing crescentic IgA nephropathy within 6 months of enrolment (MEST-C-score =C1/C2)
- Creatinine clearance >20 ml/min/1.73m2
- Proteinuria > 750 mg/24h on maximum tolerated dose of RAS blockade
- Hematuria defined as >10 RBC/hpf or hemoglobinuria >1+
- Adequate supportive care with blood pressure <125/85 mmHg and lifestyle advice at least 4 weeks before enrollment
- Dietary and lifestyle counseling during 4-week run-in period (low protein diet 0.8-1.0 g/kg/day, low sodium 2 grams/day, smoking cessation advice)
- Signed informed consent
- Patients with documented use of RAS blockade and blood pressure control <125/85 mmHg for ≥4 weeks can enroll without repeating run-in period
You will not qualify if you...
- Creatinine clearance <20 ml/min/1.73 m2
- Liver function tests > 2x upper limit of normal
- Severe interstitial fibrosis and tubular atrophy (IFTA > 70% on renal biopsy)
- Active cancer or uncontrolled infection (including HIV, HBV, HCV)
- Women who are pregnant or breastfeeding
- Immunosuppression treatment with Rituximab within 12 months, MMF, CYC, or immunomodulatory agents within 3 months, or AZA within 3 months prior to enrollment
- Glucocorticoids >20 mg/day within 1 month prior to enrollment
- Secondary IgA nephropathy associated with other diseases
- ANCA-associated vasculitis or other defined vasculitis
- Contraindications to glucocorticoids or Avacopan
- Use of strong/moderate CYP3A4 inducers
- Initiation of SGLT2 inhibitors after enrollment
- Active, untreated, or uncontrolled chronic liver disease
- Unable to give written consent
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
2
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Corbyn Bendtsen
CONTACT
Z
Zach Monson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here