CYP3A4/5 and PGP activity in renal transplantation.A study assessing in vivo hepatic and intestinal CYP3A4/5 and PGP activity in kidney transplant recipients and its relationship with genetic and non-genetic variables and the pharmacokinetics and metabolism of Tacrolimus.

• Conditions: Effect of genetic (single nucleotide polymorphisms of genes encoding drug metabolising enzymes and drug transporters) and non-genetic factors (e.g. age, time after transplantation, concommitant medication, renal function, liver dysfunction) on in vivo hepatic and intestinal CYP3A4 and 5 and PGP activity in renal allograft recipients.; MedDRA version: 9.1Level: LLTClassification code 10038533Term: Renal transplant

• Registration Number: EUCTR2008-004158-33-BE
• Lead Sponsor: Department of Nephrology and Renal Transplantation, KU Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Chronic stable renal allograft recipients (> 1 year after transplantation) treated with Tacrolimus (Prograft® or Advagraf®).
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

- Age < 18 years.
- Females with child bearing potential, not using an acceptable method of birth control.
- Nursing and pregnant women. Pregnancy tests will be performed before drug administration.
- Known allergy or intolerance to either Erythromycin, Midazolam or Fexofenadine.
- Concomitant treatment with opioid- or antipsychotic drugs.
- Severe chronic lung disease and chronic respiratory insufficiency.
- Chronic heart failure.
- Severe liver disease.
- Anaemia (haemoglobin < 11 g/dL).
- Hypoalbuminemia (< 25 g/L).
- Combined organ transplants.
- Known non-compliance.
- Alcohol intake > 7 units/week.
- Smoking.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To asses in vivo hepatic and intestinal CYP3A4 and 5 and PGP activity in renal allograft recipients.;Secondary Objective: To asses the relationship of in vivo hepatic and intestinal CYP3A4 and 5 and PGP activity in renal allograft recipients with:<br>- the recipients genotype.<br>- potential non-genetic determinants of in vivo CYP3A4 and 5 and PGP activity (e.g. concomittant medication, renal function, liver function, age, gender, .....)<br>- pharmacokinetics and metabolism of immunosuppressive drugs.;Primary end point(s): The effect of genetic and non-genetic factors on the disposition of Midazolam and Fexofenadine, as markers of, respectively, in vivo CYP3A4/5 and PGP activity in renal allograft recipients.