Pharmacokinetic Study to Rectal and Sublingual Administration of Tacrolimus in Future Kidney Transplant Patients

Maastricht University Medical Center18 enrolled

Overview

The purpose of this study is to investigate the pharmacokinetics of rectal and sublingual administration of tacrolimus and to compare with pharmacokinetics after oral administration of tacrolimus in renal transplant patients before transplantation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Organ Transplantation

Interventions

TacrolimusDRUG

Oral: 0,1 mg/kg Rectal: 15 mg Sublingual: 0,04 mg/kg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients that will have a kidney transplant patient and will be treated with tacrolimus. As well as hemodialysis patients as well as peritoneal dialysis patients are included. * Age: 18 - 65 years * Patient's informed consent Exclusion Criteria: * Patients that use drugs that interact with tacrolimus * Patients that participate in other studies * Patients that are treated with tacrolimus

Locations (1)

Maastricht University Hospital

Maastricht, Netherlands

RECRUITING

Outcomes

Primary Outcomes

Area under the curve, bioavailability, time of maximal concentration, elimination constant

Time frame: t = 0, ½, 1, 2, 4, 8, 12, 24, 36 and 48 hours

Central Contacts

Afke van de Plas, Hospital Pharmacist

CONTACT

+31433874733 a.vande.plas@mumc.nl

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.