Study of Therapeutic Monitoring of CellCept (Mycophenolate Mofetil) After Kidney Transplantation
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 13 - 75 |
| Updated: | 6/3/2016 |
| Start Date: | July 2004 |
| End Date: | January 2008 |
A Randomized, Open-label Study of Various Dosing Regimens of CellCept Combined With Various Dosing Regimens of Cyclosporine or Tacrolimus on Treatment Failure in Kidney Transplantation Patients
This 3 arm study will evaluate the efficacy and safety of various dosing regimens of
CellCept combined with various dosing regimens of cyclosporine or tacrolimus in kidney
transplantation patients. Patients will be randomized to one of 3 dosing regimens to receive
concentration-controlled CellCept with reduced cyclosporine or tacrolimus,
concentration-controlled CellCept with standard cyclosporine or tacrolimus, or fixed-dose
CellCept (1g bid) with standard cyclosporine or tacrolimus. The anticipated time on study
treatment is 1-2 years, and the target sample size is 500+ individuals.
CellCept combined with various dosing regimens of cyclosporine or tacrolimus in kidney
transplantation patients. Patients will be randomized to one of 3 dosing regimens to receive
concentration-controlled CellCept with reduced cyclosporine or tacrolimus,
concentration-controlled CellCept with standard cyclosporine or tacrolimus, or fixed-dose
CellCept (1g bid) with standard cyclosporine or tacrolimus. The anticipated time on study
treatment is 1-2 years, and the target sample size is 500+ individuals.
Inclusion Criteria:
- male or female patients 13-75 years of age
- single organ recipient (kidney only) from living (related or unrelated) or cadaveric
heart-beating donors
- patient receiving first or second kidney transplant
Exclusion Criteria:
- immunosuppressive therapy (except corticosteroid treatment) within previous 28 days
for a first transplant and 3 months for a second transplant
- history of malignancy in last 5 years (except successfully treated localized
non-melanoma skin cancer)
We found this trial at
51
sites
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