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Monoclonal Antibodies

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

Phase 1 & 2

Waitlist Available

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6 months post-transplant

Awards & highlights

No Placebo-Only Group

Summary

This trial is designed to study the safety and efficacy of isatuximab in kidney transplant candidates. The primary objectives are to characterize the safety and tolerability of isatuximab in these patients, and to evaluate the efficacy of isatuximab in desensitization of patients awaiting kidney transplantation. Secondary objectives include characterizing the safety profile of isatuximab, assessing its pharmacokinetic profile, evaluating its immunogenicity, and assessing its overall efficacy in desensitization of patients awaiting kidney transplantation.

Eligible Conditions

Immune Disorders

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 months post-transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 months post-transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months post-transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Abnormal Electrolytes Parameters

Number of Participants With Abnormal Metabolism Parameters

Number of Participants With Hematological Abnormalities

+4 more

Secondary study objectives

Duration for Achieving Target cPRA

Duration of Response (DOR)

Number of Kidney Transplant Offers

+15 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort B: Participants with cPRA 80.00% to 99.89%Experimental Treatment6 Interventions

Participants with cPRA between 80.00% to 99.89% (indicating active candidates on kidney transplant waitlist with no living donor cleared for donation) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks).

Group II: Cohort A: Participants with cPRA >=99.90%Experimental Treatment6 Interventions

Participants with calculated panel reactive antibodies (cPRA) \>=99.90% (indicating active candidates on kidney transplant waitlist) received isatuximab 10 milligrams per kilogram (mg/kg), intravenous (IV) infusion, once weekly (QW) for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then every 2 weeks (Q2W) for subsequent treatment cycles (each cycle of 28 days) until unacceptable adverse events (AEs) or participant's decision to stop the treatment (maximum treatment duration: 13 weeks).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Isatuximab SAR650984

2015

Completed Phase 2

~580

Methylprednisolone or equivalent

2007

Completed Phase 4

~50