Text Size

Pharmacokinetic Study on the Combination of Everolimus-Tacrolimus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2006 by Hospital Universitario Ramon y Cajal.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Novartis
Astellas Pharma Inc
Information provided by:
Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier:
NCT00325325
First received: May 11, 2006
Last updated: October 25, 2006
Last verified: May 2006
History of Changes

May 11, 2006
October 25, 2006
January 2006
Not Provided
12-hour PK profiles of everolimus and tacrolimus on day 14 post-transplantation with everolimus 1.5 mg versus 3 mg per day
12-hour PK profiles of everolimus and tacrolimus on day 14 post-transplantation with everolimus 1,5 vs 3 mg per day.
Complete list of historical versions of study NCT00325325 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pharmacokinetic Study on the Combination of Everolimus-Tacrolimus
A Pilot Study to Investigate Pharmacokinetic Characteristics of Everolimus in Patients Treated With Tacrolimus-Based Immunosuppression in De Novo Kidney Transplantation

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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Diseases
Drug: everolimus and tacrolimus
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
June 2007
Not Provided

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-functioning kidneys
Both
18 Years to 65 Years
No
Contact: Julio Pascual, MD +34 91 3368018 julpascual@gmail.com
Spain
 
NCT00325325
EVEROTAC
Not Provided
Not Provided
Hospital Universitario Ramon y Cajal
  • Novartis
  • Astellas Pharma Inc
Study Chair: Julio Pascual, MD Hospital Ramón y Cajal
Principal Investigator: Gorka G Erauzquin, MD Hospital de Cruces, Bilbao
Principal Investigator: José M Morales, MD Hospital 12 de Octubre, Madrid
Principal Investigator: Luis Pallardó, MD Hospital Dr Peset, Valencia
Principal Investigator: Ricardo Lauzurica, MD Hospital Germans, Trias i Puyol, Badalona
Principal Investigator: Domingo del Castillo, MD Hospital Reina Sofía, Córdoba
Principal Investigator: Josep M Grinyó, MD Hospital de Bellvitge, Barcelona
Hospital Universitario Ramon y Cajal
May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP