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This study is a multicenter, single-arm, open-label, 24 weeks, and investigator-initiated clinical trial to assess the influence of CYP3A5 polymorphism on liver function abnormality and the trough level change after conversion to Advagraf® in liver transplant recipients.
All subjects who are liver transplant recipients taking Tacrolimus bid and adaptable to be registered for the study will be classified by expressive or non-expressive CYP3A5 polymorphism genotype and Advagraf® will be administered same dose as Tacrolimus bid der day in 24 weeks.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Expressor | Experimental | CYP3A5 expressor; containing CYP3A5*1 wild-type allele(*1/*1 type & *1/*3 type) intervention: Advagraf conversion |
|
| Non-expressor | Active Comparator | CYP3A5 non-expressor: without CYP3A5*1 allele( *3/*3 type) intervention: Advagraf conversion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Advagraf | Drug | same dose as Tacrolimus bid der day in 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| liver function abnormality rate | 24 Weeks |
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Inclusion Criteria:
19 years old and above.
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 willing to sign his/her consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sung-Eun Kim | Contact | +82-10-6361-7139 | loveu0322@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Kwang-Woong Lee, Dr. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32911703 | Derived | 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. |
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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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