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Non-inferiority Study of Safety and Efficacy of Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in Kidney Transplant Recipients

NCT01025817 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 613

Last updated 2015-11-11

Study results available
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Summary

The purpose of this phase 3b study is to compare the safety and efficacy of everolimus with low dose tacrolimus to mycophenolate mofetil with standard dose tacrolimus in kidney transplant recipients.

Conditions

  • Kidney Transplant

Interventions

DRUG

Everolimus and tacrolimus

Everolimus: * Dosage form: 0.75 mg, 0.25 mg, and 0.5 mg tablets * Dose: 1.5 mg per day * Frequency: 0.75 mg twice daily Tacrolimus: * Dose adjusted to maintain specific blood levels

DRUG

mycophenolate mofetil and tacrolimus

Mycophenolate mofetil: - Dose form: 250 mg capsule - Dose: 2g per day - Frequency: 1g twice daily Tacrolimus: - Dose adjusted to maintain specific blood levels

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

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 NCT01025817 on ClinicalTrials.gov