NCT06676579 · Mayo Clinic
Avacopan in Crescentic Immunoglobulin A Nephropathy (IgAN)
What this study is about
The purpose of this study is to evaluate the effectiveness 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.
View original scientific description
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.
Interventions
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)
Primary outcome measures
Change in proteinuria measured by results of protein total, 24-hour urine collection at baseline compared to collection at 12 months.
Time frame: 12 months
A response is based on the average of proteinuria quantified twice over a 2-weeks period at 12 months.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age \> 18 years
- Kidney biopsy showing crescentic IgA nephropathy within 6 months of enrolment (MEST-C-score =C1/C2).
- Quantified creatinine clearance \>20 ml/min/1.73m2
- Quantified Proteinuria \> 750 mg/24h based on a 24h urine collection while on maximum tolerated dose of RAS blockade
- Hematuria defined as \>10 RBC/hpf or hemoglobinuria \>1+
- Patients need to be in adequate supportive care (blood pressure \<125/85mmHg, lifestyle advice, and maximum doses tolerable of RAS blockade) at least 4 weeks prior to enrollment
- Patients would receive dietary and lifestyle counseling prior enrollment: low protein (0.8-1.0 g/kg/day) diet, low sodium (2 grams/day) intake, indication for smoke cessation, during the 4 weeks run-in period
- Has signed an informed consent form prior to any study-related procedures
- Patients with documented use of RAS blockade and adequate blood pressure control (\<125/85 mmHg) for ≥4 weeks, can be enrolled in the study and randomized with
Where
- Jacksonville, Florida
- Rochester, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 3, 2025 · Source of record for eligibility and locations