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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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The purpose of this study is to determine whether maintenance renal transplant patients receiving Myfortic can reduce or discontinue GI prophylaxis medications.
GI prophylaxis is common post kidney transplant and is routinely used in patients receiving a variety of different immunosuppressive regimens. Cellcept and prednisone are often the biggest concern for GI distress and GI ulcers. Routine use of GI prophylaxis medications post-transplant are potentially one mental obstacle to transplant clinicians being fully persuaded of the GI neutral effect of myfortic in the immunosuppressive regimen. Patients receiving myfortic (as part of the conversion in the US02 study) are theoretically at a reduced risk for GI upset and development of GI ulcers. These patients are ideal candidates to discontinue their GI prophylaxis medications while taking myfortic.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GI medication | Drug | Patients on daily dosing were asked to discontinue their GI medication at baseline. Patients on twice daily dosing were asked to reduce GI medication to once a day at baseline and asked to discontinue GI medication at day 30. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the success (% of patients) in discontinuing GI medications over the 90-day period or also, % of patients able to maintain reduced doses of GI medications over the 90-day period. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the cost effectiveness of discontinuing GI medications in transplant recipients. | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Bolin, MD | East Carolina University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brody School of Medicine at East Carolina University | Greenville | North Carolina | 27834 | United States |
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