Actively Recruiting
A Multi-Center, Phase II, Open Label, Randomized Trial Evaluating the Efficacy and Safety of Complement 5a Receptor Antagonist Avacopan in Crescentic IgA Nephropathy
Led by Mayo Clinic · Updated on 2025-10-03
16
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Avacopan combined with low-dose glucocorticoids for treating patients with crescentic Immunoglobulin A Nephropathy (IgAN) who are at high risk of disease progression. This Phase II, multi-center, open-label, randomized trial aims to compare Avacopan plus low-dose steroids against a higher-dose steroid regimen to understand their impact on kidney function in this patient group. Participants will be assigned to one of two treatment groups. One group will receive Avacopan orally twice daily along with low-dose prednisone tapered over 6 to 9 months, plus an intravenous dose of methylprednisolone on day 1. The other group will receive higher doses of prednisone tapered over the same period, also with intravenous methylprednisolone on day 1. Treatment duration for Avacopan is 12 months, while glucocorticoid treatment lasts between 6 and 9 months. During the study, participants will undergo regular assessments including 24-hour urine collections to measure protein levels, kidney function tests (eGFR), and evaluations of blood in the urine. These measures will be taken at baseline, 6 months, and 12 months to monitor treatment effects. The primary outcome focuses on changes in proteinuria after 12 months. The total study period extends up to 12 months with ongoing safety monitoring and data collection throughout.
CONDITIONS
Brief Title
Avacopan in Crescentic Immunoglobulin A Nephropathy (IgAN)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- Kidney biopsy showing crescentic IgA nephropathy within 6 months of enrollment (MEST-C score = C1/C2)
- Creatinine clearance greater than 20 ml/min/1.73m2
- Proteinuria greater than 750 mg/24h on maximum tolerated dose of RAS blockade
- Hematuria defined as more than 10 red blood cells per high power field or hemoglobinuria greater than 1+
- Adequate supportive care including blood pressure below 125/85 mmHg and lifestyle advice for at least 4 weeks before enrollment
- Dietary and lifestyle counseling prior to enrollment including low protein diet (0.8-1.0 g/kg/day) and low sodium intake (2 grams/day)
- Signed informed consent form
- Patients with documented use of RAS blockade and adequate blood pressure control for at least 4 weeks may be enrolled without repeating the 4-week run-in period
You will not qualify if you...
- Creatinine clearance less than 20 ml/min/1.73m2
- Liver function tests more than twice the upper limit of normal
- Severe interstitial fibrosis and tubular atrophy (greater than 70% on renal biopsy)
- Active cancer or uncontrolled infection including HIV, hepatitis B or C
- Pregnant or breastfeeding women
- Recent immunosuppressive treatment including Rituximab within 12 months, MMF, CYC, immunomodulatory agents, or AZA within 3 months
- Glucocorticoids greater than 20 mg/day within 1 month prior to enrollment
- Secondary IgA nephropathy associated with other diseases
- ANCA-associated vasculitis or other vasculitis
- Contraindications to glucocorticoids or Avacopan
- Use of strong or moderate CYP3A4 inducers
- Starting SGLT2 inhibitors after enrollment is not allowed
- Active, untreated, or uncontrolled chronic liver disease
- Unable to provide written consent
- Pregnant or lactating women as a safety measure
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive assigned drug treatments including Avacopan, Methylprednisolone, and Prednisone or Prednisolone with dose tapering over several months.
Multiple visits during treatment for medication administration and monitoring
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
Z
Zach Monson
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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