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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

NCT00369161 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2017-03-03

Study results available
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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

DRUG

Everolimus (RAD001)

DRUG

Tacrolimus

DRUG

Basiliximab

DRUG

Corticosteroids

Sponsors & Collaborators

Principal Investigators

  • Novartis · Novartis

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00369161 on ClinicalTrials.gov