Description:

ODM derived from http://clinicaltrials.gov/show/NCT00717470

Link:

http://clinicaltrials.gov/show/NCT00717470

Keywords:
Versions (2) ▾
  1. 12/9/13
  2. 4/15/14
Uploaded on:

April 15, 2014

DOI:
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License:
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00717470 Kidney Transplantation

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
age at least 18 Years
End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation (unless the graft was lost from rejection within 12 months)
Receiving a kidney transplant from a cadaveric or living (non HLA identical) donor with compatible ABO blood type
Female subject of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study
Exclusion Criteria
Receiving or having previously received an organ transplant other than a kidney
Cold ischemia time of the donor kidney > 30 hours
Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawn of support awaiting cardiac arrest)
Significant liver disease, defined as having continuously elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels >= 2 times the upper value of the normal range of the investigational site or is receiving a graft from a hepatitis C or B positive donor
Requiring initial sequential or parallel therapy with immunosuppressive antibody preparation(s)
Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation.
Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
Pregnant woman or breast-feeding mother
Subject or donor known to be HIV positive
Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, basiliximab or mycophenolate mofetil or any of the product excipients
Diagnosis of new-onset malignancy prior to transplantation, with the exception of basocellular or squamous cell carcinoma of the skin which had been treated successfully
Currently participating in another clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment
Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator