A 24-month, multicenter, randomized, open label non inferiority study of efficay and safety comparing concentration- controlled Certican in two doses (1.5 and 3.0 mg/day starting doses) with reduced Neoral versus 1.44 Myfortic with standard dose Neoral in de-novo renal transplant recipients
- Registry ID
- EUCTR2005-002854-22
- Source registry
- EUCTR
- Status
- Completed
- Phase
- PHASE3
- Sponsor
- NOVARTIS FARMA
- Start date
- 2005-08-02
- Completion date
- 2009-08-18
- Last update
- 2026-08-16
Conditions
- renal transplantation
- Prevention of the rejection in adult patients receiving a de-novo renal transplant in combination with Neoral and corticosteroids
Summary
Primary objective: To compare the composite efficacy failure rate (treated BPAR, graft loss, death, loss to follow-up) between de novo transplant patients treated with Certican and reduced Neoral dose and Myfortic with standard Neoral dose at 12 months.
Locations
- , , UK
- , , Sweden
- , , Slovakia
- , , Italy
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