A Phase 4 interventional study of ADVAGRAF® in Liver Transplantation, sponsored by Kim, Seoung-Hoon. Completed. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2018-02-06.
Sponsored by Kim, Seoung-Hoon · Phase 4, Interventional, and Screening
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.
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).
Exclusion Criteria:
One arm: Treatment conversion will take placefrom twice daily tacrolimus to once daily tacrolimus (ADVAGRAF) 3 months after transplant in new liver transplant recipients.
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.
Also known as: tacrolimus
Incidence rate of acute rejection reaction confirmed by biopsy within 24 weeks after conversion
Incidence rate of acute rejection reaction (%) = The number of subjects with at least one acute rejection reaction / Total number of subjects included in the analysis group \* 100 number of subjects in the relevant analysis set \* 100
Time frame: within 24 weeks
Severity of acute rejection reaction confirmed by biopsy within 24 weeks after conversion
Severity of acute rejection reactions is defined as the highest severity in a subject who had at least one acute rejection reaction.
Time frame: within 24 weeks
Survival rates of subjects after conversion
Time frame: at week 24
Survival rate of transplanted organs after conversion
Time frame: at week 24
Blood concentration of tacrolimus
Time frame: at week -4, week 0, week 2, week 4, week 8, week 16 and week 24
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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