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Evaluate the safety and efficacy of early corticosteroid withdrawal and simultaneous calcineurin inhibitor withdrawal in recipients of primary renal allografts maintained long-term on MMF and sirolimus.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mycophenolate mofetil | Drug | |||
| sirolimus | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Composite endpoint of either acute rejection, biopsy proven calcineurin inhibitor toxicity, or failure of the estimated BSA indexed GFR by MDRD method to improve by 20% from time randomization to 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Renal allograft function at 6 and 12 months. | ||
| Incidence of biopsy proven acute rejection at 6 and 12 months. | ||
| Time to first rejection. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steve Woodle, MD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Christ Hospital | Cincinnati | Ohio | 45267 | United States | ||
| University of Cincinnati |
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| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| D020123 | Sirolimus |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Total number of rejection episodes per patient. |
| Graft loss and patient death. |
| Incidence of treatment failure. |
| Cincinnati |
| Ohio |
| 45267 |
| United States |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D018942 | Macrolides |
| D007783 | Lactones |