Safety, pharmacokinetics, and preliminary efficacy of isatuximab in patients awaiting kidney transplantatio

Phase 1

• Conditions: (Patients awaiting) kidney transplantation; MedDRA version: 20.0Level: PTClassification code 10021425Term: Immune system disorderSystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2019-004154-28-ES
• Lead Sponsor: Sanofi-Aventis Recherche & Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-20
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 42

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified