Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab in Patients Awaiting Kidney Transplantation
Stopped early · Phase 1/Phase 2
Conditions studied: Immune System Disorder
In brief
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.
Key facts
- Study ID
- NCT04294459
- Run by
- Sanofi
- People needed
- 23
- Starts
- 2020-06-18
- Expected to finish
- 2022-05-02
- Last updated by the study team
- 2025-09-17
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- 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 — L'Hospitalet de Llobregat, Catalunya [Cataluña], Spain
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.