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

Study Overview
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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.

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

Conditions
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Organ Transplantation

Intervention / Treatment
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* Drug: Tacrolimus


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sublingual - Rectal - Oral<br>Administration order of rank: Sublingual - Rectal - Oral | Drug: Tacrolimus<br>* Oral: 0,1 mg/kg Rectal: 15 mg Sublingual: 0,04 mg/kg<br>* Other names: Prograft;|
| Experimental: Sublingual - Oral - Rectal<br>Administration order of rank: Sublingual - Oral - Rectal | Drug: Tacrolimus<br>* Oral: 0,1 mg/kg Rectal: 15 mg Sublingual: 0,04 mg/kg<br>* Other names: Prograft;|
| Experimental: Oral - Sublingual - Rectal<br>Administration order of rank: Oral - Sublingual - Rectal | Drug: Tacrolimus<br>* Oral: 0,1 mg/kg Rectal: 15 mg Sublingual: 0,04 mg/kg<br>* Other names: Prograft;|
| Experimental: Oral - Rectal - Sublingual<br>Administration order of rank: Oral - Rectal - Sublingual | Drug: Tacrolimus<br>* Oral: 0,1 mg/kg Rectal: 15 mg Sublingual: 0,04 mg/kg<br>* Other names: Prograft;|
| Experimental: Rectal - Sublingual - Oral<br>Administration order of rank: Rectal - Sublingual - Oral | Drug: Tacrolimus<br>* Oral: 0,1 mg/kg Rectal: 15 mg Sublingual: 0,04 mg/kg<br>* Other names: Prograft;|
| Experimental: Rectal - Oral - Sublingual<br>Administration order of rank: Rectal - Oral - Sublingual | Drug: Tacrolimus<br>* Oral: 0,1 mg/kg Rectal: 15 mg Sublingual: 0,04 mg/kg<br>* Other names: Prograft;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renal transplantation, tacrolimus, pharmacokinetics, rectal, sublingual, rectal administration, sublingual administration