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Avacopan for Crescentic IgA Nephropathy

This study is testing a drug called Avacopan, along with low-dose steroids (Prednisone or Prednisolone), for people with crescentic IgA Nephropathy (IgAN). IgAN is a kidney disease. Researchers want to see if this combination treatment is safe and effective in slowing down the disease for those at high risk of it getting worse. You might be able to join if you are over 18, have crescentic IgAN confirmed by a kidney biopsy within the last 6 months, and meet certain kidney function and proteinuria (protein in urine) levels. The main goal is to see how much protein in your urine changes after 12 months of treatment.

Study design
This is an interventional study with a planned enrollment of 16 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 12 months, suggesting participants will be followed for at least this duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06676579

Avacopan in Crescentic Immunoglobulin A Nephropathy (IgAN)

Recruiting
PHASE2Ages 18+InterventionalTreatment
Mayo Clinic
~16 participants
Updated 2025-10-03 on ClinicalTrials.gov
What's tested:AvacopanPrednisoneMethylprednisolone (drug)Prednisolone

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in proteinuria measured by results of protein total, 24-hour urine collection at baseline compared to collection at 12 months.
Measured over 12 months

Conditions

IgA Nephropathy (IgAN)

Explore related trials

IgA Nephropathy

Where it's being run

2 sites across 2 states
Florida1
Minnesota1

Study leadership

  • Fernando Fervenza, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic, Rochester, MN
  • Nabeel Aslam, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Corbyn Bendtsen
[email protected]
507-284-0366
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • 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.