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

This study has been completed.
Sponsor:
Information provided by:
University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT00223015
First received: September 14, 2005
Last updated: October 19, 2005
Last verified: May 2004

September 14, 2005
October 19, 2005
May 2004
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Complete list of historical versions of study NCT00223015 on ClinicalTrials.gov Archive Site
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Investigation of the Steady State Pharmacokinetics of Tacrolimus, Mycophenolate Mofetil and Fluvastatin After Renal Transplantation
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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

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Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Renal Transplantation
Drug: Fluvastatin, Tacrolimus, Mycophenolat Mofetil
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
April 2005
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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)
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00223015
002
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University of Schleswig-Holstein
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Principal Investigator: Lutz Renders, MD University of Schleswig-Holstein, campus Kiel Department odf Nephrology
University of Schleswig-Holstein
May 2004

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