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

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

June 18, 2020

Primary Completion Date

May 2, 2022

Study Completion Date

May 2, 2022

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"

Trial Locations (6)

10016

Investigational Site Number :8400002, New York

55905

Investigational Site Number :8400001, Rochester

77030

Investigational Site Number :8400004, Houston

94143

Investigational Site Number :8400003, San Francisco

08035

Investigational Site Number :7240002, Barcelona

08907

Investigational Site Number :7240001, L'Hospitalet de Llobregat

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY