Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab in Patients Awaiting Kidney Transplantation
Immune System Disorder
About this trial
This is an interventional treatment trial for Immune System Disorder focused on measuring Anti-CD38 monoclonal antibody
Eligibility 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.
Sites / Locations
- Investigational Site Number :8400003
- Investigational Site Number :8400001
- Investigational Site Number :8400002
- Investigational Site Number :8400004
- Investigational Site Number :7240002
- Investigational Site Number :7240001
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Cohort A: Participants with cPRA >=99.90%
Cohort B: Participants with cPRA 80.00% to 99.89%
Participants with calculated panel reactive antibodies (cPRA) >=99.90% (indicating active candidates on kidney transplant waitlist) received isatuximab 10 milligrams per kilogram (mg/kg), intravenous (IV) infusion, once weekly (QW) for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then every 2 weeks (Q2W) for subsequent treatment cycles (each cycle of 28 days) until unacceptable adverse events (AEs) or participant's decision to stop the treatment (maximum treatment duration: 13 weeks).
Participants with cPRA between 80.00% to 99.89% (indicating active candidates on kidney transplant waitlist with no living donor cleared for donation) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks).