The influence of CYP3A5 and ABCB1 genotype on the pharmacokinetics of twice daily Tacrolimus and Advagraf - Pharmacogenetics of twice daily Tacrolimus and Advagraf

Phase 1

• Conditions: Renal transplantation.; MedDRA version: 14.1 Level: LLT Classification code 10023438 Term: Kidney transplant System Organ Class: 100000004865

• Registration Number: EUCTR2009-013461-25-GB
• Lead Sponsor: St. George's, University of London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-17
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 330

Inclusion Criteria

1) Renal transplant recipient at least 6 weeks after transplantation on treatment with twice daily Prograf (Tacrolimus) with planned change in treatment to once daily Advagraf (prolonged release tacrolimus) as part of standard care.
2) Aged at least 18 years
3) Treatment with 5 mg prednisolone daily
4) Signed and dated informed consent obtained before screening and before performance of any protocol-specific tests.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Patients on treatment with potent cytochrome P4503A and P-glycoprotein inducers or inhibitors:

Inducers: Carbamazepine, Phenytoin, Rifampicin

Inhibitors: Diltiazem, Erythromycin, Fluconazole, Verapamil

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: 1) Determine the influence of CYP3A5 and ABCB1 genotypes on Advagraf pharmacokinetics<br> 2) Compare the influence of these genotypes on the comparison between Prograf and Advagraf pharmacokinetics<br> ;Secondary Objective: Measurement of prednisolone concentration in samples collected for tacrolimus measurement to explore the relationship between the CYP3A5 and ABCB1 genotypes and prednisolone exposure;Primary end point(s): Area under the concentration-time curve measurement compared between genotype groups. These data will be analysed both uncorrected and normalised to total daily tacrolimus dose in mg/kg.