Clinical Trial: Daratumumab in Treatment of PGNIMD and C3 GN

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: 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 Glomerulopath

Brief 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.

Detailed Summary: This study is an open-label phase 2 trial of the safety and efficacy of daratumumab, in the treatment of PGNMID and C3GN associated with monoclonal gammopathy. Subjects will be screened at outpatient Nephrology Clinic visit appointments and interested qualified subjects will be consented and offered participation in this trial. Once consent has been obtained baseline values will be established and subjects will begin treatment and follow-up for the next 12 months. Daratumumab will be administered once weekly for 8 weeks and then once every 2 weeks for 8 additional doses. Patients will be followed for a total of 12 months (6 months after the last infusion). A final visit for evaluation and collection of lab samples will be conducted at the end of the study.
Sponsor: Fernando Fervenza

Current Primary Outcome: Incidence of Treatment-Emergent Adverse Events [ Time Frame: 1 year ]

To assess the safety of daratumumab in patients with PGNMID or C3GN associated with monoclonal gammopathy. Data regarding incidence of major infection (defined as the development of pneumonia, severe urinary tract infection/pyelonephritis, sepsis, meningitis), grade 3 or 4 anemia, leukopenia or thrombocytopenia will be collected.


Original Primary Outcome: Same as current

Current Secondary Outcome: Kidney Function [ Time Frame: 1 year ]

Efficacy will be assessed through monitoring patient's disease status (i.e., active, partial remission, remission). This will be determined through measuring proteinuria and serum creatinine.


Original Secondary Outcome: Same as current

Information By: Mayo Clinic

Dates:
Date Received: March 20, 2017
Date Started: April 2017
Date Completion: December 2019
Last Updated: April 1, 2017
Last Verified: March 2017