Influence of CYP3A5 Polymorphism on Liver Function Abnormality and the Trough Level Change After Conversion
NCT ID: NCT02882113
Last Updated: 2016-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2016-07-31
2018-12-31
Brief Summary
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Detailed Description
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All subjects should check whether being registered in the hospital based on CYP3A5 polymorphism genotype during screening visit. Registered subjects will visit seven times to the hospital during the study which includes screening visit and adverse reaction, acute rejection, and trough level will be tested during this period. Subjects who are additionally agreed for PK study will be hospitalized with the state of Tacrolimus bid therapy one day ago before taking IP. On the first day of hospitalization, his/her blood will be collected. At week 1 (plus seven days) after conversion to Advagraf®, his/her blood will be collected for PK analysis.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Expressor
CYP3A5 expressor; containing CYP3A5\*1 wild-type allele(\*1/\*1 type \& \*1/\*3 type) intervention: Advagraf conversion
Advagraf
same dose as Tacrolimus bid der day in 24 weeks
Non-expressor
CYP3A5 non-expressor: without CYP3A5\*1 allele( \*3/\*3 type) intervention: Advagraf conversion
Advagraf
same dose as Tacrolimus bid der day in 24 weeks
Interventions
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Advagraf
same dose as Tacrolimus bid der day in 24 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who previously have received a liver transplant over the last six months and within last three years.
* Patients who are on Tacrolimus immunosuppressive therapy twice a day for at least two weeks.
* During Tacrolimus immunosuppressive therapy twice a day for at least two weeks, patients who have following conditions.
* Patients who have normal liver function and renal function.
* Patients who have been monitored without complication such as acute rejection.
* Patients willing to sign his/her consent.
Exclusion Criteria
* Patients who are on steroid therapy due to positive result of acute rejection test before the baseline.
* Patients who have received a transplant besides liver.
* Patients who are allergic to IP or macrolide compounds.
* Patients who are on cyclosporine, bosentan, or potassium sparing diuretic.
* Patients with genetic diseases such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
* Pregnant or lactating women.
* Patients not willing to adhere to study procedures/treatments.
19 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Principal Investigators
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Kwang-Woong Lee, Dr.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Sung-Eun Kim
Role: primary
References
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Kim JM, Ryu JH, Lee KW, Hong SK, Yang K, Choi GS, Kim YA, Lee JY, Yi NJ, Kwon CHD, Chu CW, Suh KS, Joh JW. Effect of CYP3A5 on the Once-Daily Tacrolimus Conversion in Stable Liver Transplant Patients. J Clin Med. 2020 Sep 8;9(9):2897. doi: 10.3390/jcm9092897.
Other Identifiers
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AKR-ADVLT-2014-02
Identifier Type: -
Identifier Source: org_study_id