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 4

Terminated

• Conditions: Kidney Transplantation; Delayed Graft Function

• Registration Number: NCT00217152
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-09-20
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-22
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-16
• Last Update Posted: 2011-12-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States