Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation

Astellas

Status and phase: Completed; Phase 4

Conditions: Kidney Transplantation; Renal Insufficiency, Chronic; Kidney Failure, Chronic

Treatments: Drug: Prednisone; Drug: Methylprednisolone or equivalent; Drug: Tacrolimus; Drug: Mycophenolate Mofetil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00717379

PRG-EC-2R01

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

1

Active Comparator group

Description:

steroid regimen 1

Treatment:

Drug: Mycophenolate Mofetil

Drug: Prednisone

Drug: Tacrolimus

Drug: Methylprednisolone or equivalent

2

Experimental group

Description:

steroid regimen 2

Treatment:

Drug: Mycophenolate Mofetil

Drug: Prednisone

Drug: Tacrolimus

Drug: Methylprednisolone or equivalent