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Clinical Trials/EUCTR2012-001909-24-NL
EUCTR2012-001909-24-NL
Active, not recruiting
Phase 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 enrollmentApril 27, 2012
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ConditionsHeart 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]
DrugsPrograft®, tacrolimus

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Heart and lung transplantation, first days after transplantation
Sponsor
niversity Medical Center Utrecht
Enrollment
30
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 27, 2012
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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NL-OMON20956Prof. J. Meulenbelt, MD, PhDHead of department of National Poisons Information Center Intensive Care Center of the division of Anesthesiology, Intensive Care and Emergency Medicine, University Medical Center of UtrechtP.O. Box 855003508 GA UtrechtThe Netherlands30