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A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Kidney Transplant Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00282568
First received: January 25, 2006
Last updated: November 10, 2011
Last verified: November 2011
History of Changes

January 25, 2006
November 10, 2011
August 2002
December 2008   (final data collection date for primary outcome measure)
Determine and compare the pharmacokinetics [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00282568 on ClinicalTrials.gov Archive Site
Determine the long-term safety and tolerability [ Time Frame: Until commercially available or notification by Astellas ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Kidney Transplant Patients
A Phase 2, Open-Label, Multi-center Study to Assess the Pharmacokinetics, Safety and Tolerability of Tacrolimus in Stable Kidney Transplant Patients Converted From a Prograf® Based Immunosuppression Regimen to a Modified Release (MR) Tacrolimus Based Immunosuppression Regimen

A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable kidney transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen.

This is a Phase II open-label, multi-center conversion study in stable, adult kidney transplant recipients to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable kidney transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Kidney Transplantation
  • Drug: Tacrolimus Modified Release (MR)
    Oral
    Other Name: Advagraf, FK506E-MR, FKMR, MR4
  • Drug: tacrolimus
    Oral
    Other Name: Prograf, FK506
Experimental: 1
Interventions:
  • Drug: Tacrolimus Modified Release (MR)
  • Drug: tacrolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient is currently receiving Prograf ® based immunosuppressive therapy for kidney transplantation.
  • Patient has stable whole blood trough level concentrations of Prograf® and is clinically stable

Exclusion Criteria:

  • Patient has previously received an organ transplant other than a kidney
  • Patient is currently receiving sirolimus immunosuppression therapy.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00282568
02-0-131
No
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Director: Central Contact Astellas Pharma US, Inc.
Astellas Pharma Inc
November 2011

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