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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2004-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Kidney Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Tacrolimus/MMF/steroids throughout the study

Group Type EXPERIMENTAL

Tacrolimus

Intervention Type DRUG

oral

Mycophenolate Mofetil

Intervention Type DRUG

oral

methylprednisolone and prednisone

Intervention Type DRUG

IV and oral

2

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

Group Type EXPERIMENTAL

Tacrolimus

Intervention Type DRUG

oral

Mycophenolate Mofetil

Intervention Type DRUG

oral

methylprednisolone and prednisone

Intervention Type DRUG

IV and oral

Interventions

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Tacrolimus

oral

Intervention Type DRUG

Mycophenolate Mofetil

oral

Intervention Type DRUG

methylprednisolone and prednisone

IV and oral

Intervention Type DRUG

Other Intervention Names

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Prograf FK506 CellCept Steroids

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No