Safety Pharmacokinetics and Preliminary Efficacy of Isatuximab in Patients Awaiting Kidney Transplantation

  • STATUS
    Recruiting
  • participants needed
    42
  • sponsor
    Sanofi
Updated on 19 February 2024
chronic kidney disease
kidney transplant
nephropathy
isatuximab
sar650984
diphenhydramine

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.

Description

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).

Details
Condition Disorder of immune system
Age 18years - 70years
Treatment Isatuximab SAR650984, Acetaminophen (paracetamol) or equivalent, Ranitidine or equivalent, Diphenhydramine or equivalent, Methylprednisolone or equivalent, Montelukast or equivalent
Clinical Study IdentifierNCT04294459
SponsorSanofi
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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) 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

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
The above information is not intended to contain all considerations relevant
to a patient's potential participation in a clinical trial
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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