CFZ533 vs Tacrolimus in Kidney Transplant: Phase 2 Study Terminated After Interim Analysis

This Phase 2 study (CCFZ533A2201) was a randomized investigation designed to compare the safety, efficacy, pharmacokinetics, and pharmacodynamics of three CFZ533 dose regimens versus tacrolimus for preventing organ rejection in kidney transplant recipients. The study was planned for 60 months, with a 12-month primary analysis period followed by an additional 48-month treatment period. It enrolled 418 participants across two cohorts: Cohort 1 consisted of adult de novo kidney transplant recipients, and Cohort 2 consisted of a maintenance kidney transplant population (6-24 months post-transplant). All participants received background therapy with mycophenolate mofetil and corticosteroids, with induction therapy using basiliximab. The primary efficacy outcome for both cohorts was the percentage of participants with a composite efficacy failure event—defined as biopsy-proven acute rejection (BPAR), graft loss, or death—over 12 months post-transplantation for Cohort 1 and over 12 months post-conversion for Cohort 2. The study, which started on November 28, 2018, and had a primary completion date of October 29, 2021, was terminated after an interim analysis. Results were posted on March 23, 2026. The abstract does not provide specific numerical results for the primary or secondary outcomes, safety data, pharmacokinetic/pharmacodynamic findings, or the reasons for termination based on the interim analysis.