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Investigation of the Steady State Pharmacokinetics of Sirolimus, Mycophenolat Mofetil and Fluvastatin After Renal Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00223028
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : October 28, 2005
Sponsor:
Information provided by:
University Hospital Schleswig-Holstein

Brief Summary:

To investigate in renal transplant recipients the potential drug intreaction between Sirolimus, Mycophenolt Mofetil and Fluvastatin

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 before startin the study were included


Condition or disease Intervention/treatment Phase
Renal Transplantation Drug: sirolimus, mycophenolat mofetil, fluvastatin 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: Treatment
Official Title: Investigation of the Steady State Pharmacokinetics of Sirolimus, Mycophenolat Mofetil and Fluvastatin After Renal Transplantation
Study Start Date : April 2005
Study Completion Date : July 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: sirolimus 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): NCT00223028


Sponsors and Collaborators
University Hospital Schleswig-Holstein
Investigators
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Principal Investigator: Lutz Renders, MD University of Schleswig-Holstein, Campus Kiel, Department of Nephrology
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ClinicalTrials.gov Identifier: NCT00223028    
Other Study ID Numbers: 003
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: October 28, 2005
Last Verified: July 2004
Keywords provided by University Hospital Schleswig-Holstein:
fluvastain
sirolimus
mycophenolat mofetil
renal transplantation
Additional relevant MeSH terms:
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Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs