Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217152
Status:
TERMINATED
Last Update Posted:
2011-12-19
First Post:
2005-09-20
Brief Title:
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
Organization:
Mayo Clinic
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Roche decided to prematurely terminate study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 participants transplant The participant will be asked to return throughout the 24 months for physical exams blood and urine tests
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None