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

An Open Label, Prospective, Randomized, Controlled, Multicenter Study Assessing Fixed Dose vs. Concentration Controlled CellCept Regimens for Patients Following a Single Organ Renal Transplantation in Combination With Full Dose and Reduced Dose Calcineurin Inhibitors

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00217152

Enrollment

Registered

2005-09-22

Start date

2005-03-31

Completion date

2007-08-31

Last updated

2011-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation, Delayed Graft Function

Keywords

Kidney Transplant

Brief summary

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.

Detailed description

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.

Interventions

DRUGCellCept

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Participants must be between 18 and 70 years of age and should be receiving their first or second kidney transplant.

Design outcomes

Primary

Measure	Time frame
Treatment failure defined as a biopsy proven acute rejection, graft loss, death, or lost to follow-up	during the first 12 months following randomization
Assessment of renal function	12 months post randomization

Secondary

Measure	Time frame
The proportion of patients treated for acute rejection	—
The proportion of patients experiencing biopsy proven acute rejections	—
The time to the treatment failure	—
The time to the first proven acute rejection	—
The total number of biopsy proven, acute rejection episodes, per patient	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026