15
Participants
Start Date
November 1, 2021
Primary Completion Date
March 31, 2027
Study Completion Date
April 30, 2028
daratumumab
"Daratumumab is a CD38 (Cluster of Differentiation 38)-directed cytolytic monoclonal antibody indicated for the treatment of multiple myeloma. In this study, daratumumab will be used in highly sensitized subjects without myeloma who are awaiting a kidney transplant.~Definition of highly sensitized: Potential kidney transplant recipients with either:~* calculated panel reactive antibodies (cPRA) ≥99.9% awaiting deceased donor transplant, or~* cPRA \>98% (with \>5 years of waiting time) awaiting living donor transplant"
belatacept
Belatacept, a monoclonal antibody, is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. In this study, belatacept will be used in subjects who have not received a kidney transplant.
Bone marrow aspiration
Subjects will undergo a bone marrow aspiration prior to starting the study regimen and at 12 weeks after starting the study regimen. In subjects who undergo a kidney transplant during the study, another bone marrow aspiration will be done if it has been \>4 weeks since the previous bone marrow aspiration.
RECRUITING
University of California at San Francisco Medical Center, San Francisco
Collaborators (2)
Immune Tolerance Network (ITN)
NETWORK
Bristol-Myers Squibb
INDUSTRY
PPD Development, LP
INDUSTRY
Rho Federal Systems Division, Inc.
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH