A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Liver Recipients

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00384202
First received: October 4, 2006
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

Assessment of the safety and the efficacy of a tacrolimus modified release (MR4) based immunosuppressive regimen in stable liver transplant subjects converted on a 1:1 (mg:mg) basis from a Prograf® based immunosuppressive regimen.


Condition Intervention Phase
Transplantation
Drug: Tacrolimus
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open, Single Sequence Crossover Study to Assess the Safety and Efficacy of a Tacrolimus Modified Release, FK506E (MR4), Based Immunosuppressive Regimen in Stable Liver Transplant Patients Converted From a Prograf® Based Immunosuppressive Regimen

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Creatinine clearance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood pressure, HbA1c, Acute rejection episodes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 112
Study Start Date: October 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Tacrolimus
Immunosuppression
Other Name: Advagraf, FK506E, MR4

Detailed Description:

Multicenter, open, single sequence crossover study. Subject Enrolment: Prograf® administered twice daily is replaced by Prograf as study medication, administered twice daily.

Six weeks Prograf-Treatment Phase to confirm compliance to regimen stability requirements (see Inclusion and Exclusion Criteria), and collection of data under Prograf treatment.

Conversion from Prograf (twice daily, morning & evening dosing) total daily dose to MR4 once daily (only morning dosing) on a 1:1 (mg:mg) basis on Day 1.

Twelve weeks MR4-Treatment Phase with study assessments for safety and efficacy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Liver transplant at least 12 months prior to enrollment.
  • Prograf® dose remained unchanged for a minimum of 12 weeks prior to enrollment and tacrolimus whole blood trough level measurements were in the range of 5-15 ng/mL.

Exclusion Criteria:

  • Any unstable medical condition that could interfere with the study objectives in the opinion of the investigator.
  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: NCT00384202

Locations
France
Lyon, France, 69437
Strasbourg, France, 67098
Villejuif, France, 94801
Germany
Berlin, Germany, 13353
Hamburg, Germany, 20251
Ireland
Dublin, Ireland, Dublin 4
Poland
Warszawa, Poland, 02-005
Spain
Barakaldo, Spain, 48903
Barcelona, Spain, 08035
Santiago de Compostela, Spain, 15706
Sevilla, Spain, 41013
Valencia, Spain, 46009
United Kingdom
Birmingham, United Kingdom, B15 2TH
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use Central Contact Astellas Pharma GmbH
  More Information

Additional Information:
No publications provided

Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV
ClinicalTrials.gov Identifier: NCT00384202     History of Changes
Other Study ID Numbers: PMR-EC-1105
Study First Received: October 4, 2006
Last Updated: July 7, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Ireland: Irish Medicines Board
Poland: Ministry of Health
Spain: Spanish Agency of Medicines

Keywords provided by Astellas Pharma Inc:
Tacrolimus
Liver Transplantation

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014