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Investigation of the Steady State Pharmacokinetics of Tacrolimus, Mycophenolate Mofetil and Fluvastatin After Renal Transplantation

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ClinicalTrials.gov Identifier: NCT00223015
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : October 20, 2005
Sponsor:
Information provided by:
University of Schleswig-Holstein

Brief Summary:

Steady state pharmacokinetics of tacrolimus, mycophenolat mofetil and fluvastatin in renal transplant patients are investigated to look for potential interaction between these drugs.

All patient enrolled in this PKI-Study had no changes in the therapy before or because of the study. Only patients without changes more than 4 weeks were included


Condition or disease Intervention/treatment Phase
Renal Transplantation Drug: Fluvastatin, Tacrolimus, Mycophenolat Mofetil Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : May 2004
Study Completion Date : April 2005

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • renal transplant patients (18 - 65 years, inclusive)
  • cadaver and living renal transplants(1. Ntx, 2. Ntx)
  • Immunsuppression: Tacrolimus with or without Mycophenolat Mofetil und and fluvastatin Fluvastatin for a minimum of three months
  • writen informt consent by the patient

Exclusion Criteria:

  • contraindications for statins
  • pregnancy or lactating
  • elevated liver or muscle encymes (> 2x up to normal values: AST, ALT, bilirubine, CPK)

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): NCT00223015


Sponsors and Collaborators
University of Schleswig-Holstein
Investigators
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Principal Investigator: Lutz Renders, MD University of Schleswig-Holstein, campus Kiel Department odf Nephrology
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ClinicalTrials.gov Identifier: NCT00223015    
Other Study ID Numbers: 002
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: October 20, 2005
Last Verified: May 2004
Keywords provided by University of Schleswig-Holstein:
renal transplantation
pharmacokinetics
Fluvastatin
Mycophenolat mofetil
tacrolimus
Additional relevant MeSH terms:
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Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action