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
  Purpose

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.


Condition Intervention Phase
Kidney Diseases
Drug: everolimus and tacrolimus
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study to Investigate Pharmacokinetic Characteristics of Everolimus in Patients Treated With Tacrolimus-Based Immunosuppression in De Novo Kidney Transplantation

Resource links provided by NLM:


Further study details as provided by Hospital Universitario Ramon y Cajal:

Primary Outcome Measures:
  • 12-hour PK profiles of everolimus and tacrolimus on day 14 post-transplantation with everolimus 1.5 mg versus 3 mg per day

Estimated Enrollment: 40
Study Start Date: January 2006
Estimated Study Completion Date: June 2007
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-functioning kidneys
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00325325

Contacts
Contact: Julio Pascual, MD +34 91 3368018 julpascual@gmail.com

Locations
Spain
Hospital Ramón y Cajal Recruiting
Madrid, Spain, 28034
Principal Investigator: Julio Pascual, MD         
Sponsors and Collaborators
Hospital Universitario Ramon y Cajal
Novartis
Astellas Pharma Inc
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00325325     History of Changes
Other Study ID Numbers: EVEROTAC
Study First Received: May 11, 2006
Last Updated: October 25, 2006
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Universitario Ramon y Cajal:
Kidney Transplantation

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Everolimus
Sirolimus
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 17, 2014