CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 418 enrolled
Drug / intervention
CFZ533 - Cohort 1/Cohort 2 +8 morebiological
Likely dose
Placebo 1 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03663335
NCT03663335Phase 2Completed
CompareCT.gov

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)

Novartis Pharmaceuticals·interventional·Posted Sep 10, 2018·Updated Mar 23, 2026

In Brief

A Phase 2 clinical trial evaluating CFZ533 - Cohort 1/Cohort 2, Mycophenolate Mofetil (MMF), and 7 other interventions for Kidney Transplantation. Completed, enrolled 418 participants across 74 sites in 20 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Transplantation
CountriesArgentina, Australia, Belgium, Brazil, Canada, Czechia, France, Germany, Hungary, Italy, Japan, Latvia, Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedSep 10, 2018
Enrollment StartNov 28, 2018
Primary CompletionOct 29, 2021
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 7.8 years ago

Interventions

CFZ533 - Cohort 1/Cohort 2biological

CFZ533 was administered either by intravenous infusion or subcutaneous injection

Mycophenolate Mofetil (MMF)drug

Per local practice, 250 mg or 500 mg taken orally or 500 mg taken intravenously.

Corticosteroids (CS)drug

Taken either orally or intravenously.

Tacrolimusdrug

Standard of care immunosuppressive regimen

Induction therapy: basiliximabdrug

Lyophilized solution taken intravenously

Induction therapy: rabbit anti-thymocyte globulin (rATG)drug

Lyophilized vial taken intravenously.

Maintenance population: EC-MPSdrug

Tablet that is taken orally

Maintenance population: MMFdrug

Tablet that is taken orally

Placebo 1 mLdrug

Solution taken subcutaneously and was used for blinding of the CFZ533 doses.