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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-013461-25-GB

Enrollment

330

Registered

2010-03-17

Start date

2010-03-03

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: Prograf Product Name: Prograf 0.5, 1 and 5 mg Pharmaceutical Form: Capsule, hard Trade Name: Advagraf Product Name: Advagra

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: 1) Determine the influence of CYP3A5 and ABCB1 genotypes on Advagraf pharmacokinetics 2) Compare the influence of these genotypes on the comparison between Prograf and Advagraf pharmacokinetics ;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.	—

Measure

Time frame

Main Objective: 1) Determine the influence of CYP3A5 and ABCB1 genotypes on Advagraf pharmacokinetics 2) Compare the influence of these genotypes on the comparison between Prograf and Advagraf pharmacokinetics ;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.

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Countries

United Kingdom

Contacts

Public ContactJoint Research Office

St George's, University of London

trials@sgul.ac.uk02087254986

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026