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

NCT04294459 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-09-17

Study results available
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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 participants 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 participants awaiting kidney transplantation.

Conditions

  • Immune System Disorder

Interventions

DRUG

Isatuximab SAR650984

Pharmaceutical form: Solution for infusion Route of administration: Intravenous

DRUG

Acetaminophen (paracetamol) or equivalent

Pharmaceutical form: Tablets Route of administration: Oral

DRUG

Ranitidine or equivalent

Pharmaceutical form: Solution Route of administration: Intravenous

DRUG

Diphenhydramine or equivalent

Pharmaceutical form: Solution Route of administration: Intravenous

DRUG

Methylprednisolone or equivalent

Pharmaceutical form: Solution Route of administration: Intravenous

DRUG

Montelukast or equivalent

Pharmaceutical form: Tablets Route of administration: Oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-18
Primary Completion
2022-05-02
Completion
2022-05-02
FDA Drug
Yes

Countries

  • United States
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04294459 on ClinicalTrials.gov