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

• Status: Completed
• Trial end date: 2004-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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