Everolimus in de Novo Kidney Transplant Recipients (NEVERWOUND)
Everolimus in de Novo Kidney Transplant Recipients (NEVERWOUND)
The purpose of this study was to evaluate whether delayed (i.e. 28 ± 4 days post-transplant) administration of everolimus after transplantation reduces the risk of wound healing complications in comparison with immediate administration in de novo renal transplant patients (proportion of patients without wound/surgical complications related to initial transplant surgery) between randomization and 3 months after transplantation.
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 383 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A 3-month, Multicenter, Randomized, Open Label Study to Evaluate the Impact of Early Versus Delayed Introduction of Everolimus on Wound Healing in de Novo Kidney Transplant Recipients With a Follow-up Evaluation at 12 Month After Transplant (NEVERWOUND Study)
Study Start Date: November 2011
Actual Primary Completion Date: December 2015
Actual Study Completion Date: December 2015
Arm:
- Active Comparator: Immediate Everolimus (IE)
- Experimental: Delayed Everolimus
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Expected enrolment | 383 |
| Study start date | 1 November 2011 |
| Estimated primary completion date | 1 December 2015 |