Pharmacokinetic Study on the Combination of Everolimus-Tacrolimus

Kidney Diseases Clinical Trial

Official title:

A Pilot Study to Investigate Pharmacokinetic Characteristics of Everolimus in Patients Treated With Tacrolimus-Based Immunosuppression in De Novo Kidney Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00325325
• Other study ID #: EVEROTAC
• Status: Recruiting
• Phase: Phase 2
• First received: May 11, 2006
• Last updated: October 25, 2006
• Start date: January 2006
• Est. completion date: June 2007

Study information

• Verified date: May 2006
• Source: Hospital Universitario Ramon y Cajal
• Contact: Julio Pascual, MD
• Phone: +34 91 3368018
• Email: julpascual[@]gmail.com
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Description:

To address the pharmacokinetic 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. Patients will receive triple therapy steroids, tacrolimus and everolimus. Tacrolimus will be administered at a dose of 0.15 mg/kg/day to achieve 10-15 ng/ml 14 days, and 5-10 thereafter. During the first 6 weeks (the PK study period) everolimus will be assigned to fixed dose of 0.75 or 1.5 mg bid. After day 42, everolimus will be adjusted for 3-8 ng/ml and tacrolimus minimized to optimize graft function. Efficacy and safety parameters at 6 months post-transplantation will be secondary endpoints.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Non-functioning kidneys

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Diseases

Intervention

Drug:
• everolimus and tacrolimus

Locations

Country	Name	City	State
Spain	Hospital Ramón y Cajal	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Universitario Ramon y Cajal	Astellas Pharma Inc, Novartis

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12-hour PK profiles of everolimus and tacrolimus on day 14 post-transplantation with everolimus 1.5 mg versus 3 mg per day