A Multi Center, Prospective, Observational, Open-label, Pharmacokinetic Study of Tacrolimus in Heart and Lung Transplantation Patients during the First Days after Transplantatio
Phase 4
Completed
- Conditions
- Heart and lung transplantation100192801003868610038716
- Registration Number
- NL-OMON39373
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- 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
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
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameters are whole blood total tacrolimus concentrations and<br /><br>unbound tacrolimus plasma concentrations together with the pharmacokinetic<br /><br>parameters: AUC, Cmin, Cmax, Tmax, T1/2, Vd, CL, CL/F (=oral clearance). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Variables influencing unbound plasma tacrolimus concentrations:<br /><br>* Renal dysfunction<br /><br>* Erythrocytes or Hematocrit<br /><br>* Albumin<br /><br>* alpha-1-Acid glycoprotein<br /><br>* High density lipoprotein<br /><br>* pH<br /><br>* Daily fluid balance and body weight<br /><br>* CYP3A4/CYP3A5 gene expression, and P-glycoprotein gene expression<br /><br>* Hepatic dysfunction: bilirubin and ALAT will be used to quantify hepatic<br /><br>dysfunction<br /><br>* Diarrhoea or ileus<br /><br>* Cystic fibrosis<br /><br>* Plasma concentrations of (val)acyclovir, (val)ganciclovir, tobramycin and<br /><br>trimethoprim/sulfamethoxazole, if administered, will be measured at steady<br /><br>state as possible additional factor causing kidney dysfunction</p><br>