At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 12 Month, Multi-center, Randomized, Open-label Non-inferiority Study Comparing Safety and Efficacy of Concentration-controlled Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in de Novo Renal Transplant Recipients
In Brief
A Phase 3 clinical trial evaluating Everolimus and tacrolimus and mycophenolate mofetil and tacrolimus for Kidney Transplant. Completed, enrolled 613 participants across 50 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
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
Mycophenolate mofetil: - Dose form: 250 mg capsule - Dose: 2g per day - Frequency: 1g twice daily Tacrolimus: - Dose adjusted to maintain specific blood levels