A Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Effectiveness of Isatuximab in Patients Awaiting Kidney Transplantation

Overview

About this study

The primary purpose of this study in Phase 1 is to characterize the safety and tolerability of isatuximab in kidney transplant candidates.  The primary purpose of this study in Phase 2 is to evaluate the effectiveness of isatuximab in desensitization of patients awaiting kidney transplantation.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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/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.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mark Stegall, M.D.

Open for enrollment

Contact information:

Nong Braaten L.P.N.

Braaten.Nong@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20502017

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