Pharmacokinetics of tacrolimus in the first days after heart and lung transplantatio
Phase 1
Active, not recruiting
- Conditions
- Heart and lung transplantation, first days after transplantationMedDRA version: 19.0Level: LLTClassification code 10053349Term: Pharmacokinetic studySystem Organ Class: 100000004848Therapeutic area: Body processes [G] - Physical Phenomena [G01]
- Registration Number
- EUCTR2012-001909-24-NL
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Patients = 18 years
•Patients admitted to the ICC of UMCU after heart or lung transplantation
•Treated with tacrolimus (Prograft®; Astellas Pharma Europe)
•Informed consent obtained
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 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
• Patients < 18 years
•Patients who die within one day after admission to the ICC of UMCU
•Withdrawal of informed consent
•Allergy towards tacrolimus or macrolides
•Patients on total parenteral nutrition
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method