NCT00369161

A Twelve-month, Multicenter, Open-label, Randomized Study of the Safety, Tolerability and Efficacy of Everolimus With Basiliximab, Corticosteroids and Two Different Exposure Levels of Tacrolimus in de Novo Renal Transplant Recipients

A Twelve-month, Multicenter, Open-label, Randomized Study of the Safety, Tolerability and Efficacy of Everolimus With IL-2 Receptor Antagonist, Corticosteroids and Two Different Exposure Levels of Tacrolimus in de Novo Renal Transplant Recipients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 228 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate whether tacrolimus dose reduction in de novo renal recipients receiving everolimus can preserve renal function while maintaining efficacy.

Conditions

• Renal Transplantation

Interventions

Type	Name	Description
DRUG	Everolimus (RAD001)
DRUG	Tacrolimus
DRUG	Basiliximab
DRUG	Corticosteroids

Timeline

• Start date: 2006-06-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2006-08-29
• Last updated: 2017-03-03
• Results posted: 2011-01-19

Locations

1 site across 1 country: Switzerland