Pharmacokinetic Study on the Combination of Everolimus-Tacrolimus

• Status: Unknown status
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to address the pharmacokinetic (PK) profiles of everolimus and tacrolimus in combination in de novo kidney transplant recipients, comparing 1.5 and 3 mg per day of everolimus in fixed doses. For comparison purposes, pharmacokinetic profiles will be performed at first dose (abbreviated), 4th day, 14th day, and 42nd day post-transplantation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitario Ramon y Cajal
• Collaborators: Astellas Pharma Inc; Novartis
• Treatments: Everolimus; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

• Kidney transplant recipients aged 18-65 years old with a presumed immediately functioning graft

Exclusion Criteria:

• Non-functioning kidneys