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To Evaluate the Efficacy and Safety of ADVAGRAF® After Treatment With a Tacrolimus in New Liver Transplant Recipients

NCT03423225 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2018-02-06

No results posted yet for this study

Summary

This study's objective is to evaluate the incidence rate of acute rejection reactions after 24 weeks treatment with ADVAGRAF® following 3 months treatment with tacrolimus in new liver transplant recipients.

Treatment conversion will take place from twice daily tacrolimus to once daily tacrolimus (ADVAGRAF) 3 months after transplant in new liver transplant recipients.

Conditions

  • Liver Transplantation

Interventions

DRUG

ADVAGRAF®

Administration method The total daily dose of tacrolimus will be converted to 1:1 (mg:mg) and the total daily dose of ADVAGRAF® will be administered only once daily in the morning, starting from Day 1 (at least one hour before breakfast or 2 to 3 hours after breakfast). * Dose adjustment after conversion On Day 1, the total dose will be converted to 1:1. It is recommended to check the blood concentration of tacrolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 5\~8ng/ml for 0 to 3 months and then at 5ng/ml or below for 3 to 6 months of study treatment. * Duration of treatment The investigational product will be administered for 24 weeks.

Sponsors & Collaborators

  • Astellas Pharma Korea, Inc.

    collaborator INDUSTRY

  • Linical Korea

    collaborator INDUSTRY

  • Kim, Seoung-Hoon

    lead OTHER_GOV

Principal Investigators

  • Seoung-Hoon Kim, doctoral · National Cancer Center, Republic of Korea

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-22
Primary Completion
2017-07-18
Completion
2017-12-14

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03423225 on ClinicalTrials.gov