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

Astellas

Status and phase: Completed; Phase 3

Conditions: Kidney Transplantation

Treatments: Drug: Tacrolimus; Drug: Mycophenolate Mofetil; Drug: methylprednisolone and prednisone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00693381

FG-506-02-CEE-01

Details and patient eligibility

About

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.

Enrollment: 152 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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152 participants in 2 patient groups

1

Experimental group

Description:

Tacrolimus/MMF/steroids throughout the study

Treatment:

Drug: methylprednisolone and prednisone

Drug: Mycophenolate Mofetil

Drug: Tacrolimus

2

Experimental group

Description:

Tacrolimus/MMF/steroids with MMF reduction from week 7 to 12 and MMF discontinuation at month 3

Treatment:

Drug: methylprednisolone and prednisone

Drug: Mycophenolate Mofetil

Drug: Tacrolimus