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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

This study has been terminated.
(Roche decided to prematurely terminate study.)
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00217152
First received: September 20, 2005
Last updated: December 16, 2011
Last verified: December 2011
History of Changes
  Purpose

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 Intervention Phase
Kidney Transplantation
Delayed Graft Function
 Drug: CellCept
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Enrollment: 12
Study Start Date: March 2005
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00217152

Locations
United States, Minnesota
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00217152     History of Changes
Other Study ID Numbers: 112-05
Study First Received: September 20, 2005
Last Updated: December 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Kidney Transplant

Additional relevant MeSH terms:
Delayed Graft Function
Pathologic Processes
Mycophenolic Acid
Mycophenolate mofetil
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013