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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Maastricht University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00987103
First received: September 29, 2009
Last updated: October 21, 2010
Last verified: October 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Organ Transplantation
 Drug: Tacrolimus
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetic Study to Rectal and Sublingual Administration of Tacrolimus in Future Kidney Transplant Patients

Resource links provided by NLM:

Drug Information available for: Tacrolimus
U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Area under the curve, bioavailability, time of maximal concentration, elimination constant [ Time Frame: t = 0, ½, 1, 2, 4, 8, 12, 24, 36 and 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: September 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sublingual - Rectal - Oral
Administration order of rank: Sublingual - Rectal - Oral
 Drug: Tacrolimus
Oral: 0,1 mg/kg Rectal: 15 mg Sublingual: 0,04 mg/kg
Other Name: Prograft
Experimental: Sublingual - Oral - Rectal
Administration order of rank: Sublingual - Oral - Rectal
 Drug: Tacrolimus
Oral: 0,1 mg/kg Rectal: 15 mg Sublingual: 0,04 mg/kg
Other Name: Prograft
Experimental: Oral - Sublingual - Rectal
Administration order of rank: Oral - Sublingual - Rectal
 Drug: Tacrolimus
Oral: 0,1 mg/kg Rectal: 15 mg Sublingual: 0,04 mg/kg
Other Name: Prograft
Experimental: Oral - Rectal - Sublingual
Administration order of rank: Oral - Rectal - Sublingual
 Drug: Tacrolimus
Oral: 0,1 mg/kg Rectal: 15 mg Sublingual: 0,04 mg/kg
Other Name: Prograft
Experimental: Rectal - Sublingual - Oral
Administration order of rank: Rectal - Sublingual - Oral
 Drug: Tacrolimus
Oral: 0,1 mg/kg Rectal: 15 mg Sublingual: 0,04 mg/kg
Other Name: Prograft
Experimental: Rectal - Oral - Sublingual
Administration order of rank: Rectal - Oral - Sublingual
 Drug: Tacrolimus
Oral: 0,1 mg/kg Rectal: 15 mg Sublingual: 0,04 mg/kg
Other Name: Prograft

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00987103

Contacts
Contact: Afke van de Plas, Hospital Pharmacist +31433874733 a.vande.plas@mumc.nl

Locations
Netherlands
Maastricht University Hospital Recruiting
Maastricht, Netherlands, 6229 HX
Contact: Afke van de Plas, Hospital Pharmacist     +31433874733     a.vande.plas@mumc.nl    
Principal Investigator: Johannes van Hooff, Professor            
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Johannes van Hooff, Professor Maastricht University
  More Information

No publications provided

Responsible Party: A. van de Plas / Hospital Pharmacist, Maastricht University Hospital
ClinicalTrials.gov Identifier: NCT00987103     History of Changes
Other Study ID Numbers: 09-2-016
Study First Received: September 29, 2009
Last Updated: October 21, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
renal transplantation
tacrolimus
pharmacokinetics
rectal
 sublingual
rectal administration
sublingual administration

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013