NCT03423225

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

A Single Center, Single Arm, Open-label Study to Evaluate the Efficacy and Safety of Tacrolimus Modified Release, ADVAGRAF® After Treatment With a Tacrolimus in New Liver Transplant Recipients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Kim, Seoung-Hoon · Other Government
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is single center,open-label study with ADVAGRAF® Primary endpoint is Incidence rate of biopsy confirmed acute rejection reactions within 24 weeks following conversion+ Incidence rate of acute rejection reactions (%) = number of subjects with at least one acute rejection reaction 1)/total number of subjects in the relevant analysis set \* 100 Only those acute rejection reactions confirmed by biopsy will be acceptable as acute rejection reactions. Administration method is following 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.

Conditions

• Liver Transplantation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-03-22
• Primary completion: 2017-07-18
• Completion: 2017-12-14
• First posted: 2018-02-06
• Last updated: 2018-02-06