NCT03603548

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 9, 2018

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 27, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2023

Completed
Last Updated

July 27, 2018

Status Verified

July 1, 2018

Enrollment Period

5 years

First QC Date

July 19, 2018

Last Update Submit

July 19, 2018

Conditions

Liver Transplant RejectionImmunosuppression

Outcome Measures

Primary Outcomes (4)

  • acute rejection

    12 months

  • chronic rejection

    5 years

  • tremor

    12 months

  • de novo diabetes

    5 years

Study Arms (2)

Advagraf

ACTIVE COMPARATOR
Drug: Advagraf

Envarsus

EXPERIMENTAL
Drug: Envarsus

Interventions

EnvarsusDRUG

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)

Envarsus
AdvagrafDRUG

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)

Advagraf

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults 18- 70 after liver transplantation due to liver cirrhosis primary liver transplantation

You may not qualify if:

  • liver transplantation due to liver cirrhosis and hepatocellular carcinoma (HCC) retransplantation renal impairment Parkinson disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Warsaw Medical University

Warsaw, Poland

RECRUITING

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2018

First Posted

July 27, 2018

Study Start

July 9, 2018

Primary Completion

July 9, 2023

Study Completion

July 9, 2023

Last Updated

July 27, 2018

Record last verified: 2018-07

Locations

PL(1)