Pharmacokinetic Study to Rectal and Sublingual Administration of Tacrolimus in Future Kidney Transplant Patients
- Registration Number
- NCT00987103
- Lead Sponsor
- Maastricht University Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 18
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sublingual - Rectal - Oral Tacrolimus Administration order of rank: Sublingual - Rectal - Oral Sublingual - Oral - Rectal Tacrolimus Administration order of rank: Sublingual - Oral - Rectal Oral - Rectal - Sublingual Tacrolimus Administration order of rank: Oral - Rectal - Sublingual Rectal - Sublingual - Oral Tacrolimus Administration order of rank: Rectal - Sublingual - Oral Oral - Sublingual - Rectal Tacrolimus Administration order of rank: Oral - Sublingual - Rectal Rectal - Oral - Sublingual Tacrolimus Administration order of rank: Rectal - Oral - Sublingual
- Primary Outcome Measures
Name Time Method Area under the curve, bioavailability, time of maximal concentration, elimination constant t = 0, ½, 1, 2, 4, 8, 12, 24, 36 and 48 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Maastricht University Hospital
🇳🇱Maastricht, Netherlands