NCT00717379CompletedPhase 4
Open-Label, Randomized, Multicenter, Parallel-Group Efficacy and Safety Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Astellas Pharma Inc
- Enrollment
- 50
- Primary Endpoint
- Incidence and time to first biopsy-proven acute rejection
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Active Comparator
steroid regimen 1
Intervention: Tacrolimus (Drug)
1
Active Comparator
steroid regimen 1
Intervention: Mycophenolate Mofetil (Drug)
1
Active Comparator
steroid regimen 1
Intervention: Methylprednisolone or equivalent (Drug)
1
Active Comparator
steroid regimen 1
Intervention: Prednisone (Drug)
2
Experimental
steroid regimen 2
Intervention: Tacrolimus (Drug)
2
Experimental
steroid regimen 2
Intervention: Mycophenolate Mofetil (Drug)
2
Experimental
steroid regimen 2
Intervention: Methylprednisolone or equivalent (Drug)
2
Experimental
steroid regimen 2
Intervention: Prednisone (Drug)
Outcomes
Primary Outcomes
Incidence and time to first biopsy-proven acute rejection
Time Frame: 6 months
Secondary Outcomes
- Overall frequency of acute rejection episodes within 6 months post transplantation(6 months)
- Subject and graft survival(6 months)
- Severity of biopsy proven acute rejections (BANFF criteria) within 6 months post transplantation(6 months)
- Incidence of and time to first corticosteroid-resistant acute rejection(6 months)
Investigators
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