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

NCT00987103 | Unknown Phase 1 DMC

• 1 other identifier: 09-2-016
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Organ Transplantation

Keywords

renal transplantation; tacrolimus; pharmacokinetics; rectal; sublingual; rectal administration; sublingual administration

Outcome Measures

Primary Outcomes (1)

• Area under the curve, bioavailability, time of maximal concentration, elimination constant

  t = 0, ½, 1, 2, 4, 8, 12, 24, 36 and 48 hours

Study Arms (6)

Sublingual - Rectal - Oral

EXPERIMENTAL

Administration order of rank: Sublingual - Rectal - Oral

Drug: Tacrolimus

Sublingual - Oral - Rectal

EXPERIMENTAL

Administration order of rank: Sublingual - Oral - Rectal

Drug: Tacrolimus

Oral - Sublingual - Rectal

EXPERIMENTAL

Administration order of rank: Oral - Sublingual - Rectal

Drug: Tacrolimus

Oral - Rectal - Sublingual

EXPERIMENTAL

Administration order of rank: Oral - Rectal - Sublingual

Drug: Tacrolimus

Rectal - Sublingual - Oral

EXPERIMENTAL

Administration order of rank: Rectal - Sublingual - Oral

Drug: Tacrolimus

Rectal - Oral - Sublingual

EXPERIMENTAL

Administration order of rank: Rectal - Oral - Sublingual

Drug: Tacrolimus

Interventions

Tacrolimus DRUG

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

Also known as: Prograft

Oral - Rectal - Sublingual; Oral - Sublingual - Rectal; Rectal - Oral - Sublingual; Rectal - Sublingual - Oral; Sublingual - Oral - Rectal; Sublingual - Rectal - Oral

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients that use drugs that interact with tacrolimus
• Patients that participate in other studies
• Patients that are treated with tacrolimus

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Hospital

Maastricht, 6229 HX, Netherlands

RECRUITING

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Johannes van Hooff, Professor

  Maastricht University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Afke van de Plas, Hospital Pharmacist

CONTACT

+31433874733; a.vande.plas@mumc.nl

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 29, 2009
• First Posted: September 30, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 22, 2010

Record last verified: 2010-10

Locations

NL (1)