A Single Centered, Prospective, Open-labeled, Pharmacokinetic Pilot Study of Tacrolimus Administration via Rectiole

A Single Centered, Prospective, Open-labeled, Pharmacokinetic Pilot Study of Tacrolimus Administration via Rectiole - Spartacus Brindisi

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44442

Enrollment

Registered

2015-06-26

Start date

2015-11-02

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Verworven of congenitale hart- en longaandoeningen die leiden tot de indicatie hart- of longtransplantatie. Heart and lung transplantation

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Patients >=18 years • Patients admitted to the department of Intensive Care of UMC Utrecht • Patients eligible for intravenous tacrolimus therapy • Informed consent obtained

Exclusion criteria

Exclusion criteria: • Patients younger then 18 years • Withdrawal of informed consent • Allergy towards tacrolimus or macrolides • Patients on total parenteral nutrition • Pregnancy

Design outcomes

Primary

Measure	Time frame
The main study parameter is the bioavailability (F) of tacrolimus administered as rectiole.	—

Countries

Netherlands

Outcome results