Kidney Transplantation, Kidney Failure, Chronic, Renal Insufficiency, Chronic
Conditions
Keywords
Organ Transplantation, Tacrolimus, Prograf, Kidney, Immunosuppression
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.
Interventions
DRUGTacrolimus
oral
DRUGMycophenolate Mofetil
oral
oral
DRUGPrednisone
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and time to first biopsy-proven acute rejection | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Overall frequency of acute rejection episodes within 6 months post transplantation | 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 |
| Subject and graft survival | 6 months |
Countries
Russia
Outcome results
None listed