NCT03663335

Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients

A Partially-blinded, Active-controlled, Multicenter, Randomized Study Evaluating Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in de Novo and Maintenance Kidney Transplant Recipients (CIRRUS I)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 418 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study was to compare CFZ533 to tacrolimus (TAC) in prevention of organ rejection in kidney transplant.

Detailed description

The purpose of this study was to investigate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of three CFZ533 dose regimens in kidney transplant recipients. Study CCFZ533A2201 was a randomized, planned 60-month (5 year) study comprising of 12-months treatment for the primary analysis plus an additional 48-month treatment period. The study had 2 different cohorts: adult de novo kidney transplant recipients and maintenance kidney transplant population (6-24 months post-transplant). The study was terminated after the interim analysis.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
BIOLOGICAL	CFZ533 - Cohort 1/Cohort 2	CFZ533 was administered either by intravenous infusion or subcutaneous injection
DRUG	Mycophenolate Mofetil (MMF)	Per local practice, 250 mg or 500 mg taken orally or 500 mg taken intravenously.
DRUG	Corticosteroids (CS)	Taken either orally or intravenously.
DRUG	Tacrolimus	Standard of care immunosuppressive regimen
DRUG	Induction therapy: basiliximab	Lyophilized solution taken intravenously
DRUG	Induction therapy: rabbit anti-thymocyte globulin (rATG)	Lyophilized vial taken intravenously.
DRUG	Maintenance population: EC-MPS	Tablet that is taken orally
DRUG	Maintenance population: MMF	Tablet that is taken orally
DRUG	Placebo 1 mL	Solution taken subcutaneously and was used for blinding of the CFZ533 doses.

Timeline

• Start date: 2018-11-28
• Primary completion: 2021-10-29
• Completion: 2021-10-29
• First posted: 2018-09-10
• Last updated: 2026-03-23
• Results posted: 2026-03-23

Locations

74 sites across 20 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Czechia, France, Germany, Hungary, Italy, Japan, Latvia, Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study