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

• Sponsor: Mayo Clinic (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00217152
• Collaborator: Roche Pharma AG (Industry)
• Enrollment: 12
• Location: 1
• Duration (Months): 29
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplantation; Delayed Graft Function	Drug: CellCept	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Mar 1, 2005
• Actual Primary Completion Date: Aug 1, 2007
• Actual Study Completion Date: Aug 1, 2007

Outcome Measures

Primary Outcome Measures

1. Treatment failure defined as a biopsy proven acute rejection, graft loss, death, or lost to follow-up [during the first 12 months following randomization]

2. Assessment of renal function [12 months post randomization]

Secondary Outcome Measures

1. The proportion of patients experiencing biopsy proven acute rejections []

2. The total number of biopsy proven, acute rejection episodes, per patient []

3. The proportion of patients treated for acute rejection []

4. The time to the first proven acute rejection []

5. The time to the treatment failure []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic
• Roche Pharma AG

Investigators

• Principal Investigator: Mark D. Stegall, M.D., Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00217152
• Other Study ID Numbers: 112-05
• First Posted: Sep 22, 2005
• Last Update Posted: Dec 19, 2011
• Last Verified: Dec 1, 2011

• Keywords provided by , ,: Kidney Transplant
• Additional relevant MeSH terms: Delayed Graft Function; Mycophenolic Acid

Study Results

No Results Posted as of Dec 19, 2011