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Clinical Trials/EUCTR2012-001909-24-NL
EUCTR2012-001909-24-NLActive, not recruitingPhase 1

A Multi Center, Prospective, Observational, Open-label, Pharmacokinetic Study of Tacrolimus in Heart and Lung Transplantation Patients during the First Days after Transplantation - Spartacus

niversity Medical Center Utrecht0 sites30 target enrollmentStarted: April 27, 2012Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
30

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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

Investigators

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