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Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Liver Transplant Recipients With Additional 12-month Follow-up and Long-term Extension — CONTRAIL I  

Liver Transplant Rejection Clinical Trial

Official title:
A 12-month, Open-label, Multicenter, Randomized, Safety, Efficacy, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Two Regimens of Anti-CD40 Monoclonal Antibody, CFZ533 vs. Standard of Care Control, in Adult de Novo Liver Transplant Recipients With a 12-month Additional Follow-up and a Long-term Extension (CONTRAIL I)

Clinical Trial Summary

The purpose of this study was to investigate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of two CFZ533 dose regimens in liver transplant recipients.

Clinical Trial Description

This study allowed assessment of the ability of CFZ533 to replace Calcineurin inhibitors (CNIs) in terms of anti-rejection efficacy, while providing potentially better renal function with an expected similar safety and tolerability profile. Results of this study will inform the CFZ533 dose and regimen selection for investigation in later phases of clinical development. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03781414
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 2
Start date October 7, 2019
Completion date April 20, 2023
View Details
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