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

Organ Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00987103
• Other study ID #: 09-2-016
• Status: Recruiting
• Phase: Phase 1
• First received: September 29, 2009
• Last updated: October 21, 2010
• Start date: September 2009
• Est. completion date: September 2011

Study information

• Verified date: October 2010
• Source: Maastricht University Medical Center
• Contact: Afke van de Plas, Hospital Pharmacist
• Phone: +31433874733
• Email: a.vande.plas[@]mumc.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Organ Transplantation

Intervention

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

Locations

Country	Name	City	State
Netherlands	Maastricht University Hospital	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve, bioavailability, time of maximal concentration, elimination constant		t = 0, ½, 1, 2, 4, 8, 12, 24, 36 and 48 hours	No