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Influence of CYP3A5 Polymorphism on Liver Function Abnormality and the Trough Level Change After Conversion

Primary Purpose

Liver Dysfunction

Status

Unknown status

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Advagraf

About this trial

This is an interventional treatment trial for Liver Dysfunction

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 have Tacrolimus trough level resulted as 2 ng/mg at the baseline.
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.

Sites / Locations

Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Expressor

Non-expressor

Arm Description

CYP3A5 expressor; containing CYP3A5*1 wild-type allele(*1/*1 type & *1/*3 type) intervention: Advagraf conversion

CYP3A5 non-expressor: without CYP3A5*1 allele( *3/*3 type) intervention: Advagraf conversion

Outcomes

Primary Outcome Measures

liver function abnormality rate

Secondary Outcome Measures

Full Information

NCT ID

NCT02882113

First Posted

August 24, 2016

Last Updated

August 30, 2016

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02882113

Brief Title

Influence of CYP3A5 Polymorphism on Liver Function Abnormality and the Trough Level Change After Conversion

Official Title

Influence of CYP3A5 Polymorphism on Liver Function Abnormality and the Trough Level Change After Conversion From Tacrolimus (Bid) to Advagraf® (qd) in Stable Liver Transplant Recipients

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Unknown status

Study Start Date

July 2016 (undefined)

Primary Completion Date

August 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Expressor

Arm Type

Experimental

Arm Description

CYP3A5 expressor; containing CYP3A5*1 wild-type allele(*1/*1 type & *1/*3 type) intervention: Advagraf conversion

Arm Title

Non-expressor

Arm Type

Active Comparator

Arm Description

CYP3A5 non-expressor: without CYP3A5*1 allele( *3/*3 type) intervention: Advagraf conversion

Intervention Type

Drug

Intervention Name(s)

Advagraf

Other Intervention Name(s)

Tacrolimus

Intervention Description

same dose as Tacrolimus bid der day in 24 weeks

Primary Outcome Measure Information:

Title

liver function abnormality rate

Time Frame

24 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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 have Tacrolimus trough level resulted as 2 ng/mg at the baseline. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sung-Eun Kim

Phone

+82-10-6361-7139

loveu0322@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kwang-Woong Lee, Dr.

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sung-Eun Kim

Phone

+82-10-6361-7139

loveu0322@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

32911703

Citation

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.

Results Reference

derived

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Influence of CYP3A5 Polymorphism on Liver Function Abnormality and the Trough Level Change After Conversion

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