Imagine getting a new kidney and hoping the medicine you take will protect it for years. A major five-year study set out to test if a new drug, CFZ533, could do a better job at this than the standard treatment, tacrolimus. The goal was to prevent the terrifying trio: the body rejecting the new organ, losing the kidney graft, or death. The trial involved 418 people who had recently received a transplant or who were already living with one. It was designed to run for a full 60 months, with the first 12 months being critical for the main analysis. However, the study was terminated after an interim look at the data. The abstract does not tell us why it was stopped or what the results showed. It doesn't say whether CFZ533 was more effective, less effective, or had different side effects compared to tacrolimus. All we know is that the planned long-term comparison ended early, leaving the key question about this new treatment's performance unanswered in this public summary.
CFZ533 vs Tacrolimus in Kidney Transplant: Phase 2 Study Terminated After Interim AnalysisDid a new drug for kidney transplant patients work better than standard treatment?
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Key Takeaway
Note that the Phase 2 trial of CFZ533 versus tacrolimus was terminated after an 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.
What this means for you:
A trial comparing a new kidney transplant drug to standard therapy was stopped early; results are not reported. More on Organ Rejection
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View Original Abstract ↓
Status: COMPLETED | Phase: PHASE2
Condition(s): Kidney Transplantation
Intervention(s): CFZ533 - Cohort 1/Cohort 2 (BIOLOGICAL), Mycophenolate Mofetil (MMF) (DRUG), Corticosteroids (CS) (DRUG), Tacrolimus (DRUG), Induction therapy: basiliximab (DRUG)
This study was to compare CFZ533 to tacrolimus (TAC) in prevention of organ rejection in kidney transplant.
Detailed: 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.
Primary Outcome(s): Percentage of Participants With Composite Efficacy Failure Event (Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death) Over 12 Months Post-transplantation (Cohort 1); Percentage of Participants With Composite Efficacy Failure Event (BPAR, Graft Loss or Death) Over 12 Months Post-conversion (Cohort 2)
Enrollment: 418 (ACTUAL)
Lead Sponsor: Novartis Pharmaceuticals
Start: 2018-11-28 | Primary Completion: 2021-10-29
Results posted: 2026-03-23
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