Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation

Phase 4

Completed

• Conditions: Kidney Transplantation; Kidney Failure, Chronic; Renal Insufficiency, Chronic
• Interventions: Drug: Tacrolimus; Drug: Mycophenolate Mofetil; Drug: Methylprednisolone or equivalent; Drug: Prednisone

• Registration Number: NCT00717379
• Lead Sponsor: Astellas Pharma Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2008-07-16
• Study First Submitted QC: 2008-07-16
• Study First Posted: 2008-07-17
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-13
• Last Update Posted: 2009-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Methylprednisolone or equivalent	steroid regimen 1
2	Methylprednisolone or equivalent	steroid regimen 2
2	Prednisone	steroid regimen 2
1	Tacrolimus	steroid regimen 1
1	Mycophenolate Mofetil	steroid regimen 1
1	Prednisone	steroid regimen 1
2	Tacrolimus	steroid regimen 2
2	Mycophenolate Mofetil	steroid regimen 2

Primary Outcome Measures

Name	Time	Method
Incidence and time to first biopsy-proven acute rejection	6 months

Secondary Outcome Measures

Name	Time	Method
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