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

Kidney Transplantation Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00217152
• Other study ID #: 112-05
• Status: Terminated
• Phase: Phase 4
• First received: September 20, 2005
• Last updated: December 16, 2011
• Start date: March 2005
• Est. completion date: August 2007

Study information

• Verified date: December 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Delayed Graft Function
• Kidney Transplantation

Intervention

Drug:
• CellCept

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Roche Pharma AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment failure defined as a biopsy proven acute rejection, graft loss, death, or lost to follow-up		during the first 12 months following randomization
Primary	Assessment of renal function		12 months post randomization
Secondary	The proportion of patients experiencing biopsy proven acute rejections
Secondary	The total number of biopsy proven, acute rejection episodes, per patient
Secondary	The proportion of patients treated for acute rejection
Secondary	The time to the first proven acute rejection
Secondary	The time to the treatment failure