CFZ533 vs Standard of care in liver transplant patients - CONTRAIL I
Research type
Research Study
Full 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 (CONTRAIL I).
IRAS ID
258393
Contact name
Albert Sanchez Fueyo
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2018-001836-24
Duration of Study in the UK
3 years, 2 months, 29 days
Research summary
Liver transplantation is now recognized as the treatment of choice for end-stage liver failure. Its success can be attributed largely to the generation of selective immunosuppressive agents, which have resulted in a dramatic reduction in the incidence of acute rejection and improvements in the short- and long-term outcomes of patients. The current gold standard of care is based on the triple combination regimen with tacrolimus, mycophenolate and corticosteroids.
This clinical research study aims to find out if CCFZ533 is safe and has beneficial effects based on pharmacokinectics and pharmacodynamics compared to standard of care that is currently available of Tacrolimus, MMF and corticosteroids.
The treatment aims to replace the CNI's in terms of anti-rejection effectiveness. While providing better renal function with better safety and tolerability. The overall result of this study will be used to inform CFZ533 dose and regimen.
CFZ533 is an monoclonal anti-body which targets the CD40 signaling pathway which has been the implication for rejection and other cytotoxicity’s.This is a 12 month active-controlled, open-label multi-center, dose range finding study to evaluate the efficacy, safety, tolerability, Pharmacodynamic and pharmacokinetic of two CFZ5333 regimens (300mg or 600mg) with a 12 month additional follow up in adult de nevo liver transplant patients.
The study is being conducted globally across 47 sites, with 220 patients to be screened and 128 patients randomized. In the UK we are expecting 10 patients across 4 sites.
The countries taking part:Belgium, Czech Republic, France, Germany, Hungary, Italy, Netherlands, Spain, UK and USA.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
19/NE/0111
Date of REC Opinion
22 May 2019
REC opinion
Further Information Favourable Opinion