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

NCT02882113 | Unknown Phase 4

• 1 other identifier: AKR-ADVLT-2014-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Dysfunction

Outcome Measures

Primary Outcomes (1)

• liver function abnormality rate

  24 Weeks

Study Arms (2)

Expressor

EXPERIMENTAL

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

Drug: Advagraf

Non-expressor

ACTIVE COMPARATOR

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

Drug: Advagraf

Interventions

Advagraf DRUG

same dose as Tacrolimus bid der day in 24 weeks

Also known as: Tacrolimus

Expressor; Non-expressor

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 32911703 DERIVED

MeSH Terms

Conditions

Liver Diseases

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Kwang-Woong Lee, Dr.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sung-Eun Kim

CONTACT

+82-10-6361-7139; loveu0322@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: August 29, 2016
• Study Start: July 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 31, 2016

Record last verified: 2016-06

Locations

KR (1)