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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00987103

Enrollment

Registered

2009-09-30

Start date

2009-09-30

Completion date

2011-09-30

Last updated

2010-10-22

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

Conditions

Organ Transplantation

Keywords

renal transplantation, tacrolimus, pharmacokinetics, rectal, sublingual, rectal administration, sublingual administration

Brief summary

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.

Interventions

DRUGTacrolimus

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Area under the curve, bioavailability, time of maximal concentration, elimination constant	t = 0, ½, 1, 2, 4, 8, 12, 24, 36 and 48 hours

Countries

Netherlands

Contacts

Primary ContactAfke van de Plas, Hospital Pharmacist

a.vande.plas@mumc.nl+31433874733

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026