Status:
COMPLETED
Intensified Dosing of Cellcept (Mycophenolate Mofetil) in Kidney Transplantation
Lead Sponsor:
Nova Scotia Health Authority
Conditions:
Acute Rejection of Renal Transplant
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The primary objective of this study is to determine whether 4 grams daily of mycophenolate mofetil (MMF) results in a greater proportion of individuals adequately exposed as measured by drug levels (a...
Detailed Description
Several studies have shown that early exposure to adequate levels of immunosuppression are required to reduce acute rejection rates in kidney transplantation.(1, 2) Our center has shown that early exp...
Eligibility Criteria
Inclusion
- Patients undergoing single organ kidney transplantation.
- Age \> 18 years old.
- Patients who would normally receive our standard therapy of basiliximab, tacrolimus, MMF and steroids.
- All patients will be required to sign informed consent.
Exclusion
- Patients will be excluded if they require anti-thymocyte induction therapy, have documented gastroparesis, have known intolerance to MMF, or are prescribed cyclosporine.
- As a standard policy all women of childbearing age will be informed about the risks of all immunosuppressive drugs on fetal outcomes and will be required to use 2 forms of birth control.
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00943228
Start Date
February 1 2010
End Date
February 1 2012
Last Update
August 9 2012
Active Locations (1)
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1
QE II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V7