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Roche decided to prematurely terminate study.
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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
This research is being done to study the effects (good and bad) of taking CellCept based on blood concentrations versus taking a fixed dose of CellCept without measuring the blood concentration. CellCept is one of the three immunosuppressant drugs (drugs that suppress the immune system) which will be taken as part of this kidney transplant study. Cyclosporine or tacrolimus and corticosteroids are the two other drugs which will be taken.
This study is an open label study, which means the participant will know which drugs they are on. Participants will be put in one of three groups within 24 hours of the participant's transplant. The participant will be asked to return throughout the 24 months for physical exams, blood and urine tests.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CellCept | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment failure defined as a biopsy proven acute rejection, graft loss, death, or lost to follow-up | during the first 12 months following randomization | |
| Assessment of renal function | 12 months post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients experiencing biopsy proven acute rejections | ||
| The total number of biopsy proven, acute rejection episodes, per patient | ||
| The proportion of patients treated for acute rejection |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark D. Stegall, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| The time to the first proven acute rejection |
| The time to the treatment failure |
| ID | Term |
|---|---|
| D051799 | Delayed Graft Function |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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