NCT04294459

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

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study had 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 follow-up (FUP) until study cut-off. The study duration involved site visit per participant (i.e., screening, treatment, site visit FUP was approximately 42 weeks. The study duration included extended FUP per participant was approximately 97.7 weeks (depending on when the participant was enrolled).

Conditions

• Immune System Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-06-18
• Primary completion: 2022-05-02
• Completion: 2022-05-02
• First posted: 2020-03-04
• Last updated: 2025-09-17
• Results posted: 2023-05-30

Locations

6 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated drug study