Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab in Patients Awaiting Kidney Transplantation

• Status: Recruiting
• Trial end date: 2022-07-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Acetaminophen; Antibodies, Monoclonal; Diphenhydramine; Methylprednisolone; Montelukast; Promethazine; Ranitidine

Criteria

Inclusion criteria :

• Diagnosis of chronic kidney disease (CKD) and active candidate on the kidney donor waitlist at the time of screening.

• Body mass index (BMI) ≤40 kg/m2.

• Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

• Capable of giving signed informed consent.

For Participants in Cohort A: active candidates on the kidney waitlist with living donor.

For participants in Cohort B: active candidates on the kidney waitlist with no living donor cleared for donation.

Exclusion criteria:

• Significant cardiac dysfunction

• Known active, recurrent, or chronic infection

• Active lupus or uncontrolled diabetes

• Prior treatment with rituximab within 6 months from SAR650984 administration

• Inadequate organ and bone marrow function at screening

• Pregnant or breastfeeding women or women who intend to become pregnant during participation in the study

• Known intolerance or hypersensitivity to any component of SAR650984 or premedications

• Participants who are not suitable for participation as judged by the Investigator

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.