(Patients awaiting) kidney transplantation MedDRA version: 20.0 Level: PT Classification code 10021425 Term: Immune system disorder System Organ Class: 10021428 - Immune system disorders
Conditions
Sponsors
Sanofi-Aventis Recherche & Développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participant must be 18 to 70 years of age - 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 19
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - 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 Objective: - 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.;Primary end point(s): Phase 1 AEs/ SAEs and laboratory abnormalities - List of Adverse events (AEs)/serious adverse events (SAEs), laboratory abnormalities during Phase 1 period. Phase 2: Response rate - Proportion of participants meeting at least one of the predefined efficacy criteria as measured by single antigen bead assay.;Timepoint(s) of evaluation of this end point: Phase 1 - Up to 30 days after last study treatment Phase 2 - Baseline to 26 weeks after last study treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Proportion of participants with AEs/SAEs/laboratory abnormalities. 2. Concentration of SAR650984 observed at the end of intravenous infusion. 3. Maximum concentration of SAR650984 observed after the first infusion. 4. Time to reach Cmax 5. Last concentration observed above the lower limit of quantification after the first infusion. 6. Time of Clast 7. Concentration observed just before treatment administration during repeated dosing. 8. Area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval T (168 hours) 9. Proportion of participants with anti-drug antibodies (ADA) against isatuximab. 10. Duration of time the response lasts from when achieved. 11. Proportion of participants who achieved target calculated panel reactive antibodies (cPRA). 12. Duration of time the target cPRA lasts from when achieved 13. Number of anti-HLA-antibody reduced to below positivity cutoff as measured in a SAB assay. Abbreviations: HLA = human leukocyte antigen, SAB = single antigen bead 14. Time from baseline to when participant received first transplant offer, if applicable. 15. Time from wait listed to transplant surgery, if applicable. 16. Number of transplant offers received for each participant, if applicable. 17. Proportion of participants who experienced any antibody mediated rejection (AMR), if applicable. 18. Time from transplant surgery to first episode of AMR, if applicable. 19. Proportion of participants with graft survival at 6 month post-transplant surgery, if applicable.;Timepoint(s) of evaluation of this end point: 1. Up to 30 days after last study treatment (LST) 2. Baseline up to 1 week after first study treatment (FST) 3. Baseline up to 1 week after FST 4. Baseline up to 1 week after FST 5. Baseline up to 1 week after FST 6. Baseline up to 1 week after FST 7. Baseline to end of treatment 8. Baseline up to 1 week after FST 9. Baseline to 9 weeks after LST 10. Baseline to 26 weeks aft | — |
Countries
Spain, United States
Contacts
Public ContactUnidad de Estudios Clínicos
sanofi-aventis, s.a.
Outcome results
None listed