CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 59 enrolled
Drug / intervention
CFZ533 +4 morebiological
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Kidney transplant recipients from heart-beating deceased, living unrelated, or HLA non-identical living related donors
  • ✓Cold ischemia time (CIT) less than 30 hours
  • ✓Written informed consent
Key exclusion· 7
  • ✕Non-heart-beating donor organs
  • ✕ABO incompatible or CDC crossmatch positive transplant
  • ✕Second kidney allograft (except if first was lost due to surgical complication)
  • ✕High immunological risk for rejection

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

Search/NCT02217410
NCT02217410Phase 2Completed
CompareCT.gov

A 12-month Randomized, Multiple Dose, Open-label, Study Evaluating Safety, Tolerability, Pharmacokinetics/Pharmacodynamics (PK/PD) and Efficacy of an Anti-CD40 Monoclonal Antibody, CFZ533, in Combination With Mycophenolate Mofetil (MMF) and Corticosteroids (CS), With and Without Tacrolimus (Tac), in de Novo Renal Transplant Recipients

Novartis Pharmaceuticals·interventional·Posted Aug 15, 2014·Updated Sep 28, 2021

In Brief

A Phase 2 clinical trial evaluating CFZ533, Tacrolimus (Tac), and 3 other interventions for Kidney Transplantation. Completed, enrolled 59 participants across 14 sites in 4 countries.

Detailed Summary

The purpose of this study was to investigate the safety, tolerability, pharmacokinetics (PK) and potential for CFZ533 to replace calcineurin inhibitors (CNI), while providing a similar rate of acute rejection prophylaxis and renal function in a de novo renal transplant population receiving an allograft from standard criteria donors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Transplantation
CountriesBrazil, Germany, Netherlands, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 15, 2014
Enrollment StartFeb 5, 2015
Primary CompletionNov 29, 2017
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 11.9 years ago

Interventions

CFZ533biological

Tacrolimus (Tac)drug

Mycophenolate mofetil (MMF)drug

Corticosteroids (CS)drug

anti-IL2 Inductionbiological