Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Immunosuppressive Agents; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Mycophenolate mofetil; Mycophenolic Acid; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone; Tacrolimus

Criteria

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