Status:
COMPLETED
A Study in Kidney Transplant Subjects to Investigate the Optimal Suppression of Immunity to Help Prevent Kidney Rejection
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To compare how well the new formulation of Tacrolimus® used once daily, in combination with other drugs helps prevent the rejection of a new kidney after transplantation compared to the twice daily do...
Eligibility Criteria
Inclusion
- 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
- 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- Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawn of support awaiting cardiac arrest)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
Key Trial Info
Start Date :
May 14 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2010
Estimated Enrollment :
1252 Patients enrolled
Trial Details
Trial ID
NCT00717470
Start Date
May 14 2008
End Date
March 2 2010
Last Update
November 1 2024
Active Locations (110)
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1
Buenos Aires, Argentina, C1425FAB
2
Córdoba, Argentina, X5016KEH
3
Innsbruck, Austria, A-6020
4
Linz, Austria, A-4010