Avacopan in Crescentic Immunoglobulin A Nephropathy (IgAN)
Phase 2
Not yet recruiting
- Conditions
- IgA Nephropathy (IgAN)
- Interventions
- Registration Number
- NCT06676579
- Lead Sponsor
- Mayo Clinic
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High Doses Glucocorticoid Methylprednisolone (drug) * Methylprednisolone 1g intravenous on day +1 * 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) Avacopan and Low Doses Glucocorticoid Methylprednisolone (drug) * Methylprednisolone 1g intravenous on day +1 * 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) * Avacopan 30 mg oral twice a day (1-0-1) for 12 months Avacopan and Low Doses Glucocorticoid Prednisolone * Methylprednisolone 1g intravenous on day +1 * 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) * Avacopan 30 mg oral twice a day (1-0-1) for 12 months High Doses Glucocorticoid Prednisone * Methylprednisolone 1g intravenous on day +1 * 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) Avacopan and Low Doses Glucocorticoid Avacopan * Methylprednisolone 1g intravenous on day +1 * 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) * Avacopan 30 mg oral twice a day (1-0-1) for 12 months
- Primary Outcome Measures
Name Time Method Change in proteinuria measured by results of protein total, 24-hour urine collection at baseline compared to collection at 12 months. 12 months A response is based on the average of proteinuria quantified twice over a 2-weeks period at 12 months.
- Secondary Outcome Measures
Name Time Method Change in proteinuria >50% 12 months This is based on the average of proteinuria quantified twice over a 2-weeks period at 12 months.
Change in eGFR (using 2021 CKD-EPI Formula) 6 months, 12 months • Change in eGFR (using 2021 CKD-EPI Formula) at 6 and 12 months compared to baseline
Change in hematuria from Baseline to 12 month visit. 12 months Hematuria is measured in the urinalysis done at baseline and 12-month visit.
Trial Locations
- Locations (2)
Mayo Clinic in Florida
🇺🇸Jacksonville, Florida, United States
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States