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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.

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.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-004158-33-BE
Enrollment
Unknown
Registered
2008-09-09
Start date
2008-09-17
Completion date
Unknown
Last updated
2012-03-19

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

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: 9.1 Level: LLT Classification code 10038533 Term: Renal transplant

Interventions

Trade Name: Dormicum 5 mg/5ml Pharmaceutical Form: Solution for injection INN or Proposed INN: MIDAZOLAM HYDROCHLORIDE CAS Number: 59467968 Concentration unit: mg/ml milligram(s)/millilitre Concentrat

Sponsors

Department of Nephrology and Renal Transplantation, KU Leuven
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: - Age 7 units/week. - Smoking.

Design outcomes

Primary

MeasureTime frame
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: - the recipients genotype. - potential non-genetic determinants of in vivo CYP3A4 and 5 and PGP activity (e.g. concomittant medication, renal function, liver function, age, gender, .....) - 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.—

Countries

Belgium

Outcome results

None listed

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