Kidney Transplantation
Conditions
Keywords
Kidney, Prograf, Transplant, Advagraf, Immunosuppression, FK506
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 dose of Tacrolimus
Interventions
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 30 hours * Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawn of support awaiting cardiac arrest) * Significant liver disease, defined as having continuously elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy failure rate | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Renal Function, acute rejection, Biopsy confirmed acute rejection | 24 weeks |
Countries
Argentina, Austria, Belgium, Czechia, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom
Outcome results
None listed