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

October 21, 2010 updated by: Maastricht University Medical Center
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6229 HX
        • Recruiting
        • Maastricht University Hospital
        • Contact:
        • Principal Investigator:
          • Johannes van Hooff, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Sublingual - Rectal - Oral
Administration order of rank: Sublingual - Rectal - Oral
Drug: Tacrolimus
Oral: 0,1 mg/kg Rectal: 15 mg Sublingual: 0,04 mg/kg
Other Names:
  • Prograft
EXPERIMENTAL: Sublingual - Oral - Rectal
Administration order of rank: Sublingual - Oral - Rectal
Drug: Tacrolimus
Oral: 0,1 mg/kg Rectal: 15 mg Sublingual: 0,04 mg/kg
Other Names:
  • Prograft
EXPERIMENTAL: Oral - Sublingual - Rectal
Administration order of rank: Oral - Sublingual - Rectal
Drug: Tacrolimus
Oral: 0,1 mg/kg Rectal: 15 mg Sublingual: 0,04 mg/kg
Other Names:
  • Prograft
EXPERIMENTAL: Oral - Rectal - Sublingual
Administration order of rank: Oral - Rectal - Sublingual
Drug: Tacrolimus
Oral: 0,1 mg/kg Rectal: 15 mg Sublingual: 0,04 mg/kg
Other Names:
  • Prograft
EXPERIMENTAL: Rectal - Sublingual - Oral
Administration order of rank: Rectal - Sublingual - Oral
Drug: Tacrolimus
Oral: 0,1 mg/kg Rectal: 15 mg Sublingual: 0,04 mg/kg
Other Names:
  • Prograft
EXPERIMENTAL: Rectal - Oral - Sublingual
Administration order of rank: Rectal - Oral - Sublingual
Drug: Tacrolimus
Oral: 0,1 mg/kg Rectal: 15 mg Sublingual: 0,04 mg/kg
Other Names:
  • Prograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
t = 0, ½, 1, 2, 4, 8, 12, 24, 36 and 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Johannes van Hooff, Professor, Maastricht University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ANTICIPATED)

September 1, 2011

Study Completion (ANTICIPATED)

September 1, 2011

Study Registration Dates

First Submitted

September 29, 2009

First Submitted That Met QC Criteria

September 29, 2009

First Posted (ESTIMATE)

September 30, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 22, 2010

Last Update Submitted That Met QC Criteria

October 21, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-2-016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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