A Study in Kidney Transplant Subjects to Investigate the Optimal Suppression of Immunity to Help Prevent Kidney Rejection
Phase 4
Completed
- Conditions
- Kidney Transplantation
- Interventions
- Registration Number
- NCT00717470
- Lead Sponsor
- Astellas Pharma Inc
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1252
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- Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawn of support awaiting cardiac arrest)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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Advagraf + MMF + Basilixmab + steroids Simulect oral Advagraf + MMF + Basilixmab + steroids methylprednisolone / prednisone oral Advagraf (dose 1) + MMF + steroids methylprednisolone / prednisone oral Advagraf (dose 2) + MMF + steroids Advagraf® oral Prograf + MMF + Steroids Prograf® oral Advagraf (dose 1) + MMF + steroids Advagraf® oral Advagraf (dose 1) + MMF + steroids Mycophenolate Mofetil oral Advagraf (dose 2) + MMF + steroids Mycophenolate Mofetil oral Advagraf (dose 2) + MMF + steroids methylprednisolone / prednisone oral Prograf + MMF + Steroids methylprednisolone / prednisone oral Advagraf + MMF + Basilixmab + steroids Advagraf® oral Advagraf + MMF + Basilixmab + steroids Mycophenolate Mofetil oral Prograf + MMF + Steroids Mycophenolate Mofetil oral
- Primary Outcome Measures
Name Time Method Efficacy failure rate 24 weeks
- Secondary Outcome Measures
Name Time Method Renal Function, acute rejection, Biopsy confirmed acute rejection 24 weeks