NCT00154284

Everolimus in a Cyclosporine Microemulsion-free Regimen Compared to a Low-dose Cyclosporine Microemulsion Regimen, in de Novo Kidney Transplant Patients

A 12 Month, Multicenter, Randomized, Parallel, Open-label Study, to Evaluate Renal Function and Efficacy of Everolimus With Basiliximab and Cyclosporine Microemulsion Discontinuation at 3 Month Post-transplant Versus Minimization, in de Novo Kidney Transplant Recipients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of everolimus in combination with basiliximab, and steroids with and without cyclosporine microemulsion in de novo kidney transplant recipients.

Detailed description

This is a combined analysis using 81 patients randomized and treated in CRAD001A2419 (NCT00154284) with 33 randomized and treated in CRAD001A2423 (NCT00170807). This approach is reflected in the protocol amendments for each study, and the one clinical study report for both.

Conditions

• Organ Transplantation, Renal Transplantation

Interventions

Type	Name	Description
DRUG	Everolimus (Certican)
DRUG	Cyclosporine (Neoral)
DRUG	Steroid	Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
DRUG	Basiliximab (Simulect)

Timeline

• Start date: 2005-07-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2005-09-12
• Last updated: 2018-08-09
• Results posted: 2011-03-11