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A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Kidney Transplantation

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ClinicalTrials.gov Identifier: NCT00189839
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : July 9, 2014
Sponsor:
Information provided by:
Astellas Pharma Inc

Brief Summary:
The purpose of this study is to evaluate and to compare the efficacy and safety of a triple modified release tacrolimus FK506E (MR4) / MMF / steroid regimen with a triple standard tacrolimus FK506 / MMF / steroid regimen in patients undergoing kidney transplantation. It shall be demonstrated that FK506E (MR4) is non-inferior to FK506 with regards to the primary endpoint.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: tacrolimus Phase 3

Detailed Description:
A multicentre, 1:1 randomised, double blind, double dummy, two arm parallel group phase III study comparing a triple modified release tacrolimus FK506E (MR4) / MMF / steroid regimen with a triple standard tacrolimus FK506 / MMF / steroid regimen.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 699 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Multicentre, Randomised, Double Blind, Two Arm Parallel Group Study to Evaluate and Compare the Efficacy and Safety of Modified Release Tacrolimus FK506E (MR4) Versus Tacrolimus FK506 in Combination With MMF (Cellcept®) and Steroids in Patients Undergoing Kidney Transplantation
Study Start Date : August 2004
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 Drug: tacrolimus
Immunosuppression
Other Name: FK506E, MR4
Experimental: 2 Drug: tacrolimus
Immunosuppression
Other Name: FK506E, MR4



Primary Outcome Measures :
  1. Time to and incidence of biopsy-proven acute rejections [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Overall rate of acute rejections [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients receiving a kidney transplant from a cadaveric donor or a living non HLA identical donor between 5 and 65 years of age with compatible ABO blood type.
  • Patients with end stage kidney disease who are suitable candidates for primary renal transplantation or re-transplantation (unless the graft was lost because of immunological reasons within 12 months).

Exclusion Criteria:

  • Patients receiving or having previously received an organ transplant other than a kidney.
  • Patients with a high immunological risk, defined as a panel reactive antibodies (PRA) grade >50% in the previous 6 months and/or with a previous graft survival of less than 12 months due to immunological reasons.
  • Cold ischaemia time of the donor kidney >30 hours.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00189839


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Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Principal Investigator: B Krämer Klinikum der Universität Regensburg

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV
ClinicalTrials.gov Identifier: NCT00189839     History of Changes
Other Study ID Numbers: FG-506E-12-03
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: July 9, 2014
Last Verified: July 2014

Keywords provided by Astellas Pharma Inc:
Tacrolimus
Kidney transplantation
Transplantation, kidney
Renal Transplantation
Transplantation, renal

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action