NCT06676579 Avacopan in Crescentic Immunoglobulin A Nephropathy (IgAN)
| NCT ID | NCT06676579 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mayo Clinic |
| Condition | IgA Nephropathy (IgAN) |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2025-06-09 |
| Primary Completion | 2028-03-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 16 participants in total. It began in 2025-06-09 with a primary completion date of 2028-03-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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 without repeating a 4-week run-in period. Exclusion Criteria * Creatinine clearance \<20 ml/min/1.73 m2 * Liver function tests \> 2x upper limit of normal. (Serious cases of hepatotoxicity have been reported in patients with avacopan during first approval and ADVOCATE study (29) (30) * Severe interstitial fibrosis and tubular atrophy (IFTA \> 70% on renal biopsy) * Active cancer or acute non-controlled infection (including HIV, HBV, HCV) * Women who are pregnant or breastfeeding * Immunosuppression treatment: * Rituximab less than 12 months prior to enrollment * MMF, CYC, or immunomodulatory agents within 3 months prior to enrollment * AZA within 3 months prior to enrollment. * Glucocorticoids \>20 mg/day within 1 month prior to enrollment * Secondary IgA nephropathy (associated with gastrointestinal diseases, infection, autoimmune, malignancy, respiratory tract, or skin) * ANCA-associated vasculitis or other vasculitis diagnostic defined by ACR criteria/Chapel Hill Consensus conference * Contraindication to use any of the protocol treatments (glucocorticoids, avacopan) * Use of a strong/moderate CYP3A4 inducer * Initiation of SGLT2 inhibitors is not allowed once patient has been enrolled in the study. Patients who have been on an SGLT2 inhibitor prior to enrollment on the study may continue on this therapy, at the same dose. No dose increase is allowed. * Active, untreated and/or uncontrolled chronic liver disease (chronic active hepatitis B, untreated hepatitis C, uncontrolled autoimmune hepatitis, cirrhosis * Unable to give written consent form * As a safety measure patients who are pregnant or lactating will not be enrolled in the study.
Contact & Investigator
Fernando Fervenza, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic, Rochester, MN
Frequently Asked Questions
Who can join the NCT06676579 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying IgA Nephropathy (IgAN). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06676579 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06676579 currently recruiting?
Yes, NCT06676579 is actively recruiting participants. Contact the research team at bendtsen.corbyn@mayo.edu for enrollment information.
Where is the NCT06676579 trial being conducted?
This trial is being conducted at Jacksonville, United States, Rochester, United States.
Who is sponsoring the NCT06676579 clinical trial?
NCT06676579 is sponsored by Mayo Clinic. The principal investigator is Fernando Fervenza, MD at Mayo Clinic, Rochester, MN. The trial plans to enroll 16 participants.