Avacopan in Crescentic Immunoglobulin A Nephropathy (IgAN)

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT06676579
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • IgA Nephropathy (IgAN)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Avacopan — DRUG
    Avacopan is a complement 5a receptor (C5aR) antagonist, orally active.
  • Prednisone — DRUG
    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
  • Methylprednisolone (drug) — DRUG
    Methylprednisolone 1g intravenous on day +1
  • Prednisolone — DRUG
    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)

Study Details

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.

Key Dates

Start date
Jun 9, 2025
Status verified
Oct 2025
Primary completion
Mar 2, 2028
Completion
Mar 2, 2029

Study Design

Enrollment
16 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Avacopan and Low Doses Glucocorticoid
    * 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
  • Active Comparator: High Doses Glucocorticoid
    * 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)

Primary Outcome Measure

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 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo Clinic in FloridaJacksonvilleFlorida32224
Nabeel Aslam (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in RochesterRochesterMinnesota55905
Fernando Custodio Fervenza (PRINCIPAL_INVESTIGATOR)

Find similar trials in Jacksonville, FL

By research site
Mayo Clinic in Florida· Jacksonville, FLMayo Clinic in Rochester· Rochester, MN

Related Studies