Hepatic and intestinal CYP3A4/5 activity in renal transplantation.A study assessing in vivo hepatic and intestinal CYP3A4/5 activity at different time-points and in different clinical settings after renal transplantation and its relationship with genotype, pharmacokinetics and metabolism of Tacrolimus and outcome.

• 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 activity in renal allograft recipients.; MedDRA version: 9.1Level: LLTClassification code 10038533Term: Renal transplant

• Registration Number: EUCTR2007-004069-16-BE
• Lead Sponsor: Department of Nephrology and Renal Transplantation, KU Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

- De novo primary renal allograft recipients.
- Chronic stable renal allograft recipients.
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 or Midazolam.
- 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
Primary end point(s): The effect of genetic and non-genetic factors on the disposition of Midazolam, as a marker of in vivo CYP3A4 and 5 activity, in renal allograft recipients.;Main Objective: To asses in vivo hepatic and intestinal CYP3A4 and 5 activity in renal allograft recipients at different time-points and in different clinical settings after renal transplantation. ;Secondary Objective: To asses the relationship of in vivo hepatic and intestinal CYP3A4 and 5 activity in renal allograft recipients with:<br>- the recipients genotype.<br>- pharmacokinetics and metabolism of immunosuppressive drugs.<br>- outcome.