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Adult patients after liver transplantation initially treated with traditional Tacrolimus variant- Prograf, switched on day 10 after orthotropic liver transplantation (OLTx) on prolonged released Tacrolimus variant in 1:1 ratio ( Advagraf vs. Envarsus)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advagraf | Active Comparator |
| |
| Envarsus | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Envarsus | Drug | Patients after liver transplantation initially treated with traditional Tacrolimus variant- Prograf, switched on day 10 after OLTx on prolonged released Tacrolimus variant in 1:1 ratio ( Advagraf vs. Envarsus) |
| Measure | Description | Time Frame |
|---|---|---|
| acute rejection | 12 months | |
| chronic rejection | 5 years | |
| tremor | 12 months | |
| de novo diabetes | 5 years |
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Inclusion Criteria:
adults 18- 70 after liver transplantation due to liver cirrhosis primary liver transplantation
Exclusion Criteria:
liver transplantation due to liver cirrhosis and hepatocellular carcinoma (HCC) retransplantation renal impairment Parkinson disease
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Warsaw Medical University | Recruiting | Warsaw | Poland |
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| Advagraf | Drug | Patients after liver transplantation initially treated with traditional Tacrolimus variant- Prograf, switched on day 10 after OLTx on prolonged released Tacrolimus variant in 1:1 ratio ( Advagraf vs. Envarsus) |
|
| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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