At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Kidney biopsy confirming PGNMID or C3 glomerulonephritis
- ✓For C3GN: serum electrophoresis with immunofixation confirming monoclonal gammopathy
- ✓Proteinuria ≥1000 mg/24 hours
- ✕Pregnancy
- ✕Hepatitis B or C, or HIV infection
- ✕Multiple myeloma
- ✕Hemoglobin <8.5 g/dL
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Single-center Phase 2 Open-label Trial Evaluating Efficacy and Safety of Daratumumab in Treatment of Patients With Proliferative Glomerulonephritis With Monoclonal Immune Deposits and C3 Glomerulopathy Associated With Monoclonal Gammopathy
In Brief
A Phase 2 clinical trial evaluating Daratumumab for Membranoproliferative Glomerulonephritis. Completed, enrolled 12 participants across 1 site.
Detailed Summary
This study is being done to see if daratumumab is safe and effective in the treatment of proliferative glomerulonephritis with monoclonal immune deposits (PGNMID) and C3 glomerulopathy associated with monoclonal gammopathy (C3GN). This is an inflammatory disease in the kidney due to the production of abnormal proteins. There are no known standard effective treatments for patients with PGNMID and C3GN secondary to monoclonal gammopathy. These diseases are caused by abnormal production of proteins (monoclonals) by abnormal clones. Daratumamb has been shown to be effective in treating patients with multiple myeloma a disease which also caused by over production of monoclonal proteins from abnormal clones. Everyone in this study will receive daratumumab.
Study Details
Timeline
Interventions
Intravenously (IV) at a dose of 16 mg/kg once weekly for 8 weeks, followed by once every 2 weeks for eight additional doses