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

NCT ID: NCT00987103

Last Updated: 2010-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Organ Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sublingual - Rectal - Oral

Administration order of rank: Sublingual - Rectal - Oral

Group Type EXPERIMENTAL

Tacrolimus

Intervention Type DRUG

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

Sublingual - Oral - Rectal

Administration order of rank: Sublingual - Oral - Rectal

Group Type EXPERIMENTAL

Tacrolimus

Intervention Type DRUG

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

Oral - Sublingual - Rectal

Administration order of rank: Oral - Sublingual - Rectal

Group Type EXPERIMENTAL

Tacrolimus

Intervention Type DRUG

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

Oral - Rectal - Sublingual

Administration order of rank: Oral - Rectal - Sublingual

Group Type EXPERIMENTAL

Tacrolimus

Intervention Type DRUG

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

Rectal - Sublingual - Oral

Administration order of rank: Rectal - Sublingual - Oral

Group Type EXPERIMENTAL

Tacrolimus

Intervention Type DRUG

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

Rectal - Oral - Sublingual

Administration order of rank: Rectal - Oral - Sublingual

Group Type EXPERIMENTAL

Tacrolimus

Intervention Type DRUG

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

Interventions

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Tacrolimus

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

Intervention Type DRUG

Other Intervention Names

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Prograft

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Maastricht University Hospital

Principal Investigators

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Johannes van Hooff, Professor

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

Locations

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Maastricht University Hospital

Maastricht, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Afke van de Plas, Hospital Pharmacist

Role: CONTACT

[email protected]
+31433874733

Facility Contacts

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Afke van de Plas, Hospital Pharmacist

Role: primary

[email protected]
+31433874733

Other Identifiers

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09-2-016

Identifier Type: -

Identifier Source: org_study_id