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

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ClinicalTrials.gov Identifier: NCT00987103
Recruitment Status : Unknown
Verified October 2010 by Maastricht University Medical Center.
Recruitment status was:  Recruiting
First Posted : September 30, 2009
Last Update Posted : October 22, 2010
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Organ Transplantation Drug: Tacrolimus Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Study to Rectal and Sublingual Administration of Tacrolimus in Future Kidney Transplant Patients
Study Start Date : September 2009
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 30, 2009    Key Record Dates
Last Update Posted: October 22, 2010
Last Verified: October 2010

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
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action