NCT01410448

Everolimus in de Novo Kidney Transplant Recipients

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 383 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	Everolimus	Everolimus was provided in blisters containing 0.25 and 0.75 mg tablets and was taken orally.
DRUG	Mycophenolate sodium	Two 360 mg tablets were administered twice daily at 12-hour intervals. The tablets were swallowed whole in order to maintain the integrity of the enteric coating.
DRUG	Cyclosporine	Cyclosporine was supplied as blisters containing 100 mg, 50 mg, 25 mg and 10 mg soft-gelatin capsules and was administered orally.
DRUG	Steroids	Steroids were administered according to local clinical practice.

Timeline

• Start date: 2011-11-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2011-08-05
• Last updated: 2017-06-16
• Results posted: 2017-06-16

Locations

22 sites across 1 country: Italy