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A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Kidney Transplantation

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00481819
First received: May 31, 2007
Last updated: March 10, 2009
Last verified: March 2009

May 31, 2007
March 10, 2009
July 2007
March 2009   (final data collection date for primary outcome measure)
Event rate of patients with acute rejections [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Event rate of patients with acute rejections within the first 12 weeks following transplantation. [ Time Frame: 12 weeks ]
Complete list of historical versions of study NCT00481819 on ClinicalTrials.gov Archive Site
  • Incidence of and time to acute rejections [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Overall frequency of acute rejections [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Rate of patient and graft survival following transplantation [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
Incidence of and time to acute rejections within the first 12 weeks. Overall frequency of acute rejections within the first 12 weeks. Rate of patient and graft survival following transplantation
Not Provided
Not Provided
 
A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Kidney Transplantation
A Multicenter, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Combination With MMF and Steroids in Patients Undergoing Kidney Transplantation and a Pharmacokinetics Study.

The patients about to undergo kidney transplantation will be randomized to one of the following two group:

Group FK506MR: FK506MR/MMF/steroid; Group Prograf® : Prograf® /MMF/steroid. The treatment period is 3 months( 12 weeks)

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Kidney Transplantation
  • Drug: FK506MR
    oral
    Other Names:
    • Advagraf
    • Tacrolimus modified-release
    • MR4
  • Drug: Prograf
    oral
    Other Names:
    • tacrolimus
    • FK506
  • Drug: Mycophenolate Mofetil
    oral
    Other Name: MMF
  • Drug: Methylprednisolone
    oral
  • Drug: Prednisolone
    oral
  • Experimental: 1
    In combination with MMF and steroids
    Interventions:
    • Drug: FK506MR
    • Drug: Mycophenolate Mofetil
    • Drug: Methylprednisolone
    • Drug: Prednisolone
  • Active Comparator: 2
    In combination with MMF and steroids
    Interventions:
    • Drug: Prograf
    • Drug: Mycophenolate Mofetil
    • Drug: Methylprednisolone
    • Drug: Prednisolone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
March 2009
March 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Written informed consent with the date of the patient must be obtained.
  • Patient between 18-70 years of age receiving the primary kidney.
  • Female patients must have a negative pregnancy test prior to the enrolment.
  • Female patients of child bearing potential must agree to practice effective birth control during the study.

Exclusion Criteria:

  • Kidney re-transplantation patients or received an organ transplantation other than a kidney.
  • PRA>10% in the previous 6 months.
  • Patient who need antibody induction therapy.
  • Patient with significant liver disease, defined as having continuously elevated >2 times of SGPT and/or SGOT and/or total bilirubin levels during the past 28 days.
  • Patient with severe infection requiring treatment, and/or severe diarrhea, vomiting, active upper gastrointestinal tract malabsorption or active peptic ulcer.
  • Patient has any history of severe cardiovascular, respiratory disease; or history of malignancy.
  • Patient is HIV or HBsAg positive.
  • Patient is allergic to Prograf or macrolide antibiotics.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00481819
MR4KTxCN01
No
Director, Astellas Pharma, Inc
Astellas Pharma Inc
Not Provided
Principal Investigator: Prof. Ao Jianhua Department of Urologic Surgery
Astellas Pharma Inc
March 2009

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