A Randomized, Open-label Study Comparing the Effects of Low-dose Cyclosporine vs Cyclosporine Withdrawal on Renal Function in Kidney Transplant Patients Treated With CellCept and Daclizumab
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Kidney Transplantation
Both
Kidney Transplantation
Trial Information
A Randomized, Open-label Study Comparing the Effects of Low-dose Cyclosporine vs Cyclosporine Withdrawal on Renal Function in Kidney Transplant Patients Treated With CellCept and Daclizumab
Inclusion Criteria:
- adult patients greater than 18 years of age
- recipients of primary kidney transplant
- single-organ recipients (kidney only)
Exclusion Criteria:
- previous treatment with Zenapax
- history of malignancy (except localized skin cancer)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Renal function (as measured by GFR)
Outcome Time Frame:
12 months post-transplant
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
United States: Food and Drug Administration
Study ID:
M67005
NCT ID:
NCT00048152
Start Date:
December 2000
Completion Date:
March 2006
Related Keywords:
- Kidney Transplantation
Name | Location |
|---|---|
| Albany, Georgia 31701 | |
| Birmingham, Alabama 35294 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Philadelphia, Pennsylvania 19104 | |
| McLean, Virginia 22101 | |
| Hackensack, New Jersey 07601 | |
| Charleston, South Carolina |
