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 participants 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 participants awaiting kidney transplantation.
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 involved site visit per participant (i.e., screening, treatment, site
visit FUP was approximately 42 weeks.
The study duration included extended FUP per participant was approximately 97.7 weeks
(depending on when the participant was enrolled).
Drug: Isatuximab SAR650984
Pharmaceutical form: Solution for infusion
Route of administration: Intravenous
Other Name: Sarclisa
Drug: Acetaminophen (paracetamol) or equivalent
Pharmaceutical form: Tablets
Route of administration: Oral
Drug: Ranitidine or equivalent
Pharmaceutical form: Solution
Route of administration: Intravenous
Drug: Diphenhydramine or equivalent
Pharmaceutical form: Solution
Route of administration: Intravenous
Drug: Methylprednisolone or equivalent
Pharmaceutical form: Solution
Route of administration: Intravenous
Drug: Montelukast or equivalent
Pharmaceutical form: Tablets
Route of administration: Oral
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)
- 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.
Investigational Site Number :8400003
San Francisco, California, United States
Investigational Site Number :8400001
Rochester, Minnesota, United States
Investigational Site Number :8400002
New York, New York, United States
Investigational Site Number :8400004
Houston, Texas, United States
Investigational Site Number :7240002
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number :7240001
Hospitalet de Llobregat, Catalunya [Cataluña], Spain
Clinical Sciences & Operations, Study Director
Sanofi