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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

September 29, 2009
October 21, 2010
September 2009
September 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00987103 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pharmacokinetic Study to Rectal and Sublingual Administration of Tacrolimus in Future Kidney Transplant Patients
Pharmacokinetic Study to Rectal and Sublingual Administration of Tacrolimus in Future Kidney Transplant Patients

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Organ Transplantation
Drug: Tacrolimus
Oral: 0,1 mg/kg Rectal: 15 mg Sublingual: 0,04 mg/kg
Other Name: Prograft
  • Experimental: Sublingual - Rectal - Oral
    Administration order of rank: Sublingual - Rectal - Oral
    Intervention: Drug: Tacrolimus
  • Experimental: Sublingual - Oral - Rectal
    Administration order of rank: Sublingual - Oral - Rectal
    Intervention: Drug: Tacrolimus
  • Experimental: Oral - Sublingual - Rectal
    Administration order of rank: Oral - Sublingual - Rectal
    Intervention: Drug: Tacrolimus
  • Experimental: Oral - Rectal - Sublingual
    Administration order of rank: Oral - Rectal - Sublingual
    Intervention: Drug: Tacrolimus
  • Experimental: Rectal - Sublingual - Oral
    Administration order of rank: Rectal - Sublingual - Oral
    Intervention: Drug: Tacrolimus
  • Experimental: Rectal - Oral - Sublingual
    Administration order of rank: Rectal - Oral - Sublingual
    Intervention: Drug: Tacrolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
18
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Afke van de Plas, Hospital Pharmacist +31433874733 a.vande.plas@mumc.nl
Netherlands
 
NCT00987103
09-2-016
Yes
A. van de Plas / Hospital Pharmacist, Maastricht University Hospital
Maastricht University Medical Center
Not Provided
Principal Investigator: Johannes van Hooff, Professor Maastricht University
Maastricht University Medical Center
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP