Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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 patients 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 patients awaiting kidney transplantation.

Official Title

A Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab (SAR650984) in Patients Awaiting Kidney Transplantation

Details

The study will have 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 FUP until study cutoff.

The study duration that involves site visit per participant (ie, screening, treatment, site visit FUP) will be approximately 42 weeks.

The study duration including extended FUP per participant will be approximately 78 weeks (depending when the participant is enrolled).

Keywords

Immune System Disorder Anti-CD38 monoclonal antibody Immune System Diseases Acetaminophen Diphenhydramine Promethazine Methylprednisolone Ranitidine Montelukast Isatuximab SAR650984 Acetaminophen (paracetamol) or equivalent Ranitidine or equivalent Diphenhydramine or equivalent Methylprednisolone or equivalent Montelukast or equivalent

Eligibility

You can join if…

Open to people ages 18-70

:

  • 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.

You CAN'T join 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 premedications
  • Participants who are not suitable for participation as judged by the Investigator

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations

  • Investigational Site Number 8400003 accepting new patients
    San Francisco California 94143 United States
  • Investigational Site Number 8400004 accepting new patients
    Houston Texas 77030 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Sanofi
ID
NCT04294459
Phase
Phase 1/2
Study Type
Interventional
Last Updated