Effect of diltiazem and CYP3A5 genetic polymorphism on tacrolimus concentrations in Thai kidney transplant recipients

Not Applicable

• Conditions: kidney transplantation; AUC, CYP3A5, diltiazem, kidney transplantation, pharmacokinetic, tacrolimus

• Registration Number: TCTR20170206005
• Lead Sponsor: Chulalongkorn University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-06
• Study Completion: 2019-02-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Enrolling by invitation
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. First kidney transplantation
2. Living related kidney transplant patients
3. Being prescribed mycophenolate mofetil or mycophenate sodium, tacrolimus and prednisolone as maintenance immunosuppressive agent to prevent allograft rejection

Exclusion Criteria

1. more than one organ transplantation
2. ABO incompatible transplantation
3. patients who require anti-thymocyte immunoglobulin for induction therapy
4. patients who receive concomitant drugs (other than methylprednisolone, prednisolone and omeprazole) that may affect CYP3A4 and P-glycoprotein activity
5. patients with history of cirrhosis, elevated liver enzyme more than 3x of upper limit normal (AST>100 U/L and ALT>120 U/L) or hepatitis C viral infection
6. active gastrointestinal disorder
7. anemia (Hb<9 g/dL)
8. hypoalbuminemia (Alb<3 g/dL)
9. blood preesure below 110/70 mmHg
10. fever or active infection
11. incomplete data in medication record and/or computer system

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
tacrolimus blood concentrations Days 3 and 7, and after 6 months post-transplantation immunoassay

Secondary Outcome Measures

Name	Time	Method
proportion of mean trough concentration within target tacrolimus trough level Days 3 and 7, and after 6 months post-transplantation immunoassay