Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)
Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)
This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 2037 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open-label study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 24 Month, Multicenter, Randomized, Open-label Safety and Efficacy Study of Concentration-controlled Everolimus With Reduced Calcineurin Inhibitor vs Mycophenolate With Standard Calcineurin Inhibitor in de Novo Renal Transplantation
Actual Study Start Date: December 3, 2013
Actual Primary Completion Date: February 1, 2017
Actual Study Completion Date: January 17, 2018
Arm:
- Experimental: EVR+rCNI
- Active Comparator: MPA+sCNI
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Expected enrolment | 2037 |
| Study start date | 3 December 2013 |
| Estimated primary completion date | 17 January 2018 |