A Multi-center Open-label Trial Evaluating the Efficacy and Safety of Daratumumab SC in Treatment of Patients With Proliferative Glomerulonephritis With Monoclonal Immunoglobulin Deposits (PGNMID)
Mayo Clinic
Summary
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Renal biopsy read at Mayo Clinic confirming the diagnosis of PGNMID * Proteinuria ≥ 1000 mg over 24 hours * Creatinine clearance ≥ 20 mL/min/SA * Subjects able and willing to give informed consent * For female subjects of reproductive childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously during the Treatment Period, during any dose interruptions, and for 3 months after the last dose of any component of the treatment regimen. Sexual abstinence is considered a high…
Interventions
- DrugDaratumumab
1800 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
Locations (4)
- Mayo ClinicJacksonville, Florida
- Mayo ClinicRochester, Minnesota
- University North Carolina at Chapel HillChapel Hill, North Carolina
- Oregon Health and Science UniversityPortland, Oregon