CFZ533 in de novo and maintenance kidney transplant patients- CIRRUS-1
Research type
Research Study
Full title
A 12 month, partially-blinded, active-controlled, multi-centre, randomized study evualting efficacy, safety, tolerability, Pharmacokinectics(PK) and pharmacodynamics (PD) of an anti-CD40 monoclonal antibody, CFZ533 in de novo and maintenance kidney transplant recipients (CIRRUS-1)
IRAS ID
231952
Contact name
David Van Dellen
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2017-003607-22
Duration of Study in the UK
2 years, 5 months, 13 days
Research summary
Research Summary
Kidney transplantation has become a recognized medical procedure with considerable impact on extending and improving the quality of life of patients with end stage renal failure as compared to renal replacement therapy such as dialysis. At present Calcineurin inhibitors (CNI) are the preferred therapeutic intervention for end stage renal disease.
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 study consisting of 2 cohorts; cohort 1 consists of patients requiring a kidney transplant in the de novo population; cohort 2 consists of patients who had a kidney transplant 6-24 months ago; Both arms study design is a 28 day screening period and 11.5 months treatment period, where they would be randomized to one of the five arms and a follow up period of 60 days after the end of study visit.
The study is being conducted globally across 16 sites, with 200 patients in cohort 1 and 125 in cohort 2, with 19 patients from the UK.
The countries taking part: Argentina, Australia, Belgium, Brazil, Czech Republic, France, Germany, Hungary, Italy, Japan, Netherlands, Norway, Spain, Sweden, UK, and US
Summary of Results
The results of the study demonstrated that CFZ533 based regimen was numerically less efficacious than TAC based regimen for treatment of kidney transplant patients. No new safety signals were observed for CFZ533 in the study.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
18/EM/0264
Date of REC Opinion
17 Oct 2018
REC opinion
Further Information Favourable Opinion