FindTrial
Sign In

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.

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.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-004069-16-BE
Enrollment
Unknown
Registered
2007-10-03
Start date
2007-10-19
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 activity in renal allograft recipients. MedDRA version: 9.1 Level: LLT Classification code 10038533 Term: Renal transplant

Interventions

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

Sponsors

Department of Nephrology and Renal Transplantation, KU Leuven
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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: - the recipients genotype. - pharmacokinetics and metabolism of immunosuppressive drugs. - outcome.—

Countries

Belgium

Outcome results

None listed

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