CCFZ533X2201 - PoC Study in de Novo Renal Transplantation
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.
Timeline
- Start
- 2015-02-05
- Primary completion
- 2017-11-29
- Completion
- 2017-11-29
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry analysis (other test); CFZ533 + MMF (Part 2) vs Tac + MMF (Part 2); p = 0.8976; Mean Difference (Final Values) 0.095 (95% CI -0.067 to 0.263); reads as missed primary endpoint NCT02217410 ↗
release “In a recent multicenter, randomized control trial (NCT02217410), with the primary endpoint of non-inferiority on the composite endpoint, iscalimab therapy showed non-inferiority” reads as met primary endpoint novartis.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tacrolimus | Small molecule | — | — |
| Subject | iscalimab | Monoclonal antibody | — | — |
| Background | Mycophenolate Mofetil | Small molecule | — | — |
Indications
No indication recorded.