A Kidney Transplant Study to Look at the Effects of Taking Fixed Doses of CellCept Versus Taking Doses of CellCept Based on the Concentration of CellCept in the Blood When Taking Full or Reduced Dose Calcineurin Inhibitors

Phase 4TerminatedNCT00217152

Mayo Clinic12 enrolled

Overview

This research is being done to study the effects (good and bad) of taking CellCept based on blood concentrations versus taking a fixed dose of CellCept without measuring the blood concentration. CellCept is one of the three immunosuppressant drugs (drugs that suppress the immune system) which will be taken as part of this kidney transplant study. Cyclosporine or tacrolimus and corticosteroids are the two other drugs which will be taken.

This study is an open label study, which means the participant will know which drugs they are on. Participants will be put in one of three groups within 24 hours of the participant's transplant. The participant will be asked to return throughout the 24 months for physical exams, blood and urine tests.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Kidney Transplantation Delayed Graft Function

Interventions

Outcomes

Primary Outcomes

Treatment failure defined as a biopsy proven acute rejection, graft loss, death, or lost to follow-up

Time frame: during the first 12 months following randomization

Assessment of renal function

Time frame: 12 months post randomization

Secondary Outcomes

The proportion of patients experiencing biopsy proven acute rejections

The total number of biopsy proven, acute rejection episodes, per patient

The proportion of patients treated for acute rejection

The time to the first proven acute rejection

The time to the treatment failure