Status:
TERMINATED
Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab in Patients Awaiting Kidney Transplantation
Lead Sponsor:
Sanofi
Conditions:
Immune System Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief 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 parti...
Detailed Description
The study had a screening period of up to 28 days, a treatment period of up to 12 weeks, a site visit FUP of up to 26 weeks, and an extended follow-up (FUP) until study cut-off. The study duration in...
Eligibility Criteria
Inclusion
- 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/m\^2.
- 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 pre-medications.
- Participants who were not suitable for participation as judged by the Investigator.
- The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
June 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2022
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04294459
Start Date
June 18 2020
End Date
May 2 2022
Last Update
September 17 2025
Active Locations (6)
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1
Investigational Site Number :8400003
San Francisco, California, United States, 94143
2
Investigational Site Number :8400001
Rochester, Minnesota, United States, 55905
3
Investigational Site Number :8400002
New York, New York, United States, 10016
4
Investigational Site Number :8400004
Houston, Texas, United States, 77030