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| ID | Type | Description | Link |
|---|---|---|---|
| 17393 | Other Identifier | REB |
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| Name | Class |
|---|---|
| Astellas Pharma Canada, Inc. | INDUSTRY |
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Renal and kidney pancreas transplant patients will be randomized to once daily Advagraf or twice daily Prograf to assess changes in tacrolimus and mycophenolate mofetil exposure, renal allograft function, other relevant biochemical parameters and treatment related adverse effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advagraf | Active Comparator |
| |
| Prograf | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus | Drug | tacrolimus extended release capsules vs Prograf |
|
| Measure | Description | Time Frame |
|---|---|---|
| renal function | baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence of MPA exposure with Advagraf | Bioequivalence is measured using Pharmacokinetic monitoring of MPA plasma concentrations. | Baseline, 12 weeks and 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Norman Muirhead | London Health Sciences Centre Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Sciences Centre | London | Ontario | N6A 5A5 | Canada |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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