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Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00717379
Recruitment Status : Completed
First Posted : July 17, 2008
Last Update Posted : April 15, 2009
Sponsor:
Information provided by:
Astellas Pharma Inc

Tracking Information
First Submitted Date  ICMJE July 16, 2008
First Posted Date  ICMJE July 17, 2008
Last Update Posted Date April 15, 2009
Study Start Date  ICMJE May 2007
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2008)
Incidence and time to first biopsy-proven acute rejection [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2008)
  • Overall frequency of acute rejection episodes within 6 months post transplantation [ Time Frame: 6 months ]
  • Severity of biopsy proven acute rejections (BANFF criteria) within 6 months post transplantation [ Time Frame: 6 months ]
  • Incidence of and time to first corticosteroid-resistant acute rejection [ Time Frame: 6 months ]
  • Subject and graft survival [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation
Official Title  ICMJE Open-Label, Randomized, Multicenter, Parallel-Group Efficacy and Safety Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation
Brief Summary To compare the efficacy and safety of Tacrolimus in combination with MMF and Steroids in two regimens of steroid in an adult kidney transplanted population.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Kidney Transplantation
  • Kidney Failure, Chronic
  • Renal Insufficiency, Chronic
Intervention  ICMJE
  • Drug: Tacrolimus
    oral
    Other Names:
    • Prograf
    • FK506
  • Drug: Mycophenolate Mofetil
    oral
    Other Name: MMF
  • Drug: Methylprednisolone or equivalent
    oral
  • Drug: Prednisone
    oral
Study Arms  ICMJE
  • Active Comparator: 1
    steroid regimen 1
    Interventions:
    • Drug: Tacrolimus
    • Drug: Mycophenolate Mofetil
    • Drug: Methylprednisolone or equivalent
    • Drug: Prednisone
  • Experimental: 2
    steroid regimen 2
    Interventions:
    • Drug: Tacrolimus
    • Drug: Mycophenolate Mofetil
    • Drug: Methylprednisolone or equivalent
    • Drug: Prednisone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 16, 2008)
50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female subject of childbearing potential must have a negative serum pregnancy test at enrolment and must agree to maintain effective birth control during the study
  • Has an end stage kidney disease and is a suitable candidate for primary renal transplantation or retransplantation
  • Subject is receiving a kidney transplant, from a cadaveric or living donor between 5 and 65 years of age with compatible AB0 blood type

Exclusion Criteria:

  • Pregnant woman or breast-feeding mother
  • Has an immunological high risk, defined as having a most recently measured PRA grade of > 50% within the previous six months
  • Known allergy to the study drug or any of its components
  • Requires ongoing dosing with a systemic immunosuppressive drug at study entry for any reason other than kidney transplantation
  • Requires initial sequential or parallel therapy with immunosuppressive antibody preparation(s)
  • Subject or donor is known to be HIV positive
  • Has significant liver disease, defined as having during the past 28 days continuously elevated ASAT (SGOT) and/or ALAT (SGPT) levels greater than 3 times the upper value of the normal range of the investigational site
  • Diagnosis of malignancy or history of malignancy, except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
  • Has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, or active peptic ulcer
  • Previously received or is receiving an organ transplant other than kidney
  • Receiving a graft from a non-heart-beating donor
  • Cold ischemia time of the donor kidney >30 hours
  • Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00717379
Other Study ID Numbers  ICMJE PRG-EC-2R01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Disclosure Office Europe, Astellas Pharma Europe BV
Study Sponsor  ICMJE Astellas Pharma Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Central Contact ZAO Astellas Pharma Russia
PRS Account Astellas Pharma Inc
Verification Date April 2009

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