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

• Sponsor: Medical University of Warsaw (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03603548
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 60
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief Summary

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)

Condition or Disease	Intervention/Treatment	Phase
Liver Transplant Rejection; Immunosuppression	Drug: Envarsus; Drug: Advagraf	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jul 9, 2018
• Anticipated Primary Completion Date: Jul 9, 2023
• Anticipated Study Completion Date: Jul 9, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Advagraf	Drug: Advagraf; 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)
Experimental: Envarsus	Drug: Envarsus; 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)

Outcome Measures

Primary Outcome Measures

1. acute rejection [12 months]

2. chronic rejection [5 years]

3. tremor [12 months]

4. de novo diabetes [5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Warsaw Medical University	Warsaw		Poland

Sponsors and Collaborators

• Medical University of Warsaw

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medical University of Warsaw
• ClinicalTrials.gov Identifier: NCT03603548
• Other Study ID Numbers: WarsawMUAdvEnv
• First Posted: Jul 27, 2018
• Last Update Posted: Jul 27, 2018
• Last Verified: Jul 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Tacrolimus

Study Results

No Results Posted as of Jul 27, 2018