Daratumumab for Treatment of Proliferative Glomerulonephritis With Monoclonal Immune Deposits
Part of paid clinical trials in Jacksonville, Florida.
- Sponsor
- Mayo Clinic
- Study ID
- NCT05654506
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Proliferative Glomerulonephritis With Monoclonal IgG Deposits
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Daratumumab — DRUG1800 mg subcutaneous (SC) injection (total amount 15 mL) into the right/left abdominal area once weekly for 8 doses followed by once every 2 weeks for an additional 8 doses
Study Details
The purpose of this research is to study the safety and efficacy of daratumumab in inducing complete or partial remission in people with proliferative glomerulonephritis with monoclonal immunoglobulin deposits (PGNMID).
Key Dates
- Start date
- Aug 17, 2023
- Status verified
- Jun 2025
- Primary completion
- Aug 31, 2026
- Completion
- Aug 31, 2026
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Daratumumab treatment in PGNMIDSubjects with native kidney biopsy consistent with membranoproliferative glomerulonephritis with monoclonal immunoglobulin deposits will receive daratumumab.
Primary Outcome Measure
Change in proteinuria [ Time Frame: Baseline, 12 months ]
Central Contacts
- Corbyn Bendtsen507-284-0366
- Nicholas Geroux507-266-0956
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic | Jacksonville | Florida | 32224 | Nabeel Aslam, MD (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic | Rochester | Minnesota | 55905 | Fernando Fervenza, MD (PRINCIPAL_INVESTIGATOR) Ladan Zand, MD (SUB_INVESTIGATOR) |
| University North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | Patrick Taus, MD (PRINCIPAL_INVESTIGATOR) |
| Oregon Health and Science University | Portland | Oregon | 97239 | Rupali Avasare, MD (PRINCIPAL_INVESTIGATOR) |