Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab in Patients Awaiting Kidney Transplantation
Status:
Recruiting
Trial end date:
2022-07-22
Target enrollment:
Participant gender:
Summary
Primary Objectives:
- Phase 1: To characterize the safety and tolerability of isatuximab in kidney transplant
candidates.
- Phase 2: To evaluate the efficacy of isatuximab in desensitization of patients awaiting
kidney transplantation.
Secondary Objectives:
- Phase 2: To characterize the safety profile of isatuximab in kidney transplant
candidates.
- To characterize the pharmacokinetic (PK) profile of isatuximab in kidney transplant
candidates.
- To evaluate the immunogenicity of isatuximab.
- To assess the overall efficacy of isatuximab in desensitization of patients awaiting
kidney transplantation.