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

Maastricht University Medical Centre (MUMC)

Status and phase: Unknown; Phase 1

Conditions: Organ Transplantation

Treatments: Drug: Tacrolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT00987103

09-2-016

Details and patient eligibility

About

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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 6 patient groups

Sublingual - Rectal - Oral

Experimental group

Description:

Administration order of rank: Sublingual - Rectal - Oral

Treatment:

Drug: Tacrolimus

Sublingual - Oral - Rectal

Experimental group

Description:

Administration order of rank: Sublingual - Oral - Rectal

Treatment:

Drug: Tacrolimus

Oral - Sublingual - Rectal

Experimental group

Description:

Administration order of rank: Oral - Sublingual - Rectal

Treatment:

Drug: Tacrolimus

Oral - Rectal - Sublingual

Experimental group

Description:

Administration order of rank: Oral - Rectal - Sublingual

Treatment:

Drug: Tacrolimus

Rectal - Sublingual - Oral

Experimental group

Description:

Administration order of rank: Rectal - Sublingual - Oral

Treatment:

Drug: Tacrolimus

Rectal - Oral - Sublingual

Experimental group

Description:

Administration order of rank: Rectal - Oral - Sublingual

Treatment:

Drug: Tacrolimus