Mycophenolate Mofetil (MMF) Discontinuation From a Tacrolimus/MMF/Steroid Triple Regimen After Kidney Transplantation

Phase 3

Completed

• Conditions: Kidney Transplantation
• Interventions: Drug: Tacrolimus; Drug: Mycophenolate Mofetil; Drug: methylprednisolone and prednisone

• Registration Number: NCT00693381
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

Patients after kidney transplantation received immunosuppression by Tacrolimus, MMF and steroids. In one half of the patients after 7 weeks MMF was reduced by half, and after 12 weeks it was stopped. For the others MMF remained at initial dose.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Primary Completion: 2004-08
• Study Completion: 2004-08
• Study First Submitted: 2008-06-03
• Study First Submitted QC: 2008-06-06
• Study First Posted: 2008-06-09
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-17
• Last Update Posted: 2014-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

• Patient has an end stage kidney disease and is a suitable candidate for primary renal transplantation or retransplantation
• Patient is receiving a kidney transplant, from a cadaveric or living donor between 5 and 65 years of age with compatible ABO blood type

Exclusion Criteria

• Patient has an immunological high risk, defined as having a most recently measured PRA grade of >= 50% within the previous six months
• Patient requires ongoing dosing with a systemic immunosuppressive drug at study entry for any reason other than kidney transplantation
• Patient requires initial sequential or parallel therapy with immunosuppressive antibody preparation(s)
• Patient or donor is known to be HIV positive
• Patient with malignancy or history of malignancy, except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
• Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, or active peptic ulcer
• Patient is receiving a graft from a non-heart-beating donor
• Cold ischemia time of the donor kidney >= 40 hours

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	methylprednisolone and prednisone	Tacrolimus/MMF/steroids throughout the study
2	methylprednisolone and prednisone	Tacrolimus/MMF/steroids with MMF reduction from week 7 to 12 and MMF discontinuation at month 3
2	Tacrolimus	Tacrolimus/MMF/steroids with MMF reduction from week 7 to 12 and MMF discontinuation at month 3
2	Mycophenolate Mofetil	Tacrolimus/MMF/steroids with MMF reduction from week 7 to 12 and MMF discontinuation at month 3
1	Tacrolimus	Tacrolimus/MMF/steroids throughout the study
1	Mycophenolate Mofetil	Tacrolimus/MMF/steroids throughout the study

Primary Outcome Measures

Name	Time	Method
Incidence of and time to first biopsy proven acute rejection over the first 6 months post transplantation	6 months

Secondary Outcome Measures

Name	Time	Method
Incidence and seriousness of adverse events	6 months