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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Universitario Ramon 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
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014