Trials / Completed
CompletedNCT02217410
CCFZ533X2201 - PoC Study in de Novo Renal Transplantation
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 59 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CFZ533 | |
| DRUG | Tacrolimus (Tac) | |
| DRUG | Mycophenolate mofetil (MMF) | |
| DRUG | Corticosteroids (CS) | |
| BIOLOGICAL | anti-IL2 Induction |
Timeline
- Start date
- 2015-02-05
- Primary completion
- 2017-11-29
- Completion
- 2017-11-29
- First posted
- 2014-08-15
- Last updated
- 2021-09-28
- Results posted
- 2018-12-21
Locations
14 sites across 4 countries: United States, Brazil, Germany, Netherlands
Source: ClinicalTrials.gov record NCT02217410. Inclusion in this directory is not an endorsement.