Immunosuppression Clinical Trial
Official title:
Comparison of Safety and Efficacy of Two Variants of Prolonged - Released Tacrolimus (Advagraf vs. Envarsus ) in Patients After Liver Transplantation : Single Center Randomised Control Trial
| Verified date | July 2018 |
| Source | Medical University of Warsaw |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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)
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | July 9, 2023 |
| Est. primary completion date | July 9, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Poland | Warsaw Medical University | Warsaw |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Warsaw |
Poland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | acute rejection | 12 months | ||
| Primary | chronic rejection | 5 years | ||
| Primary | tremor | 12 months | ||
| Primary | de novo diabetes | 5 years |
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