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Cranoc Lipid Study in Renal Transplantation

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ClinicalTrials.gov Identifier: NCT00223041
Recruitment Status : Terminated (No possibilty to receive all plened patients for this study)
First Posted : September 22, 2005
Last Update Posted : August 8, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
Cardiovascular disease after renal transplantation is an important problem. Patients after renal transplantation with low LDL-Levels (<130mg/dl) receive Fluvastatin 80mg/day (or no medication, to look for the cardiovascular outcome with and without statins.

Condition or disease Intervention/treatment Phase
Renal Transplantation Drug: Fluvastatin Phase 2 Phase 3

Detailed Description:
Cardiovascular disease after renal transplantation is an important problem. Patients after renal transplantation with low LDL-Levels (<130mg/dl) receive Fluvastatin 80mg/day (or no medication, to look for the cardiovascular outcome with and without statins.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Cardiovascular Events in Renal Transplant Recipients With Low LDL-cholesterol Receiving Tacrolimus in Combination With the Statin Fluvastatin
Study Start Date : April 2003
Primary Completion Date : November 2009
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: A (therapy with fluvastatin 80mg retard)
kidney transplants receive in addition fluvastatin 80mg retard for 3 years
Placebo Comparator: B
no therapy with fluvastatin
Drug: Fluvastatin
Arm A receives fluvastatin Arm b receives no fluvastatin


Outcome Measures

Primary Outcome Measures :
  1. cardivasculary events (cardiovaskulary, cerebrovaskulary, peripher vaskulary) [ Time Frame: during the study ]

Secondary Outcome Measures :
  1. patients and kidney survival [ Time Frame: during the study ]
  2. amount and typ of rejection (Banff-classifikation) [ Time Frame: during the study ]
  3. change in lipids [ Time Frame: during the study ]
  4. adverse events of the statin fluvastatin [ Time Frame: during the study ]

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 (18 - 65, inclusive)
  • cadaver and living kidney transplantation (1. Ntx, 2. Ntx)
  • LDL-cholesterol ≤ 130mg/dl (-3 Mo until start of Tx)
  • Patients with a history of Myocard infarct: LDL-Cholesterol ≤ 110mg/dl
  • Immunsuppression: Tacrolimus in combination with steroids or Mycophenolat Mofetil
  • patients indulgence

Exclusion Criteria:

  • statin before the study

    • LDL-Cholesterol >130mg/dl before transplantation
    • Instabil Angina, Myocard infarct <6 months before transplantation
    • symptomatic Hypothyreosis
    • child bearing, lactating
    • elavated liver encymes (> 2x elavated: AST, ALT, bilirubine, PCK)
    • Fibrates are not allowed
    • multiorgantransplantation
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): NCT00223041


Locations
Germany
University of Schleswig-Holstein, Campus Kiel, Department of Nephrology
Kiel, Germany, 24251
Sponsors and Collaborators
University of Schleswig-Holstein
Investigators
Principal Investigator: Lutz Renders, MD University of Scghleswig-Holstein, Campus Kiel, Department of Nephrology
More Information

Responsible Party: L. Renders, University of Kiel, department of Nephrology
ClinicalTrials.gov Identifier: NCT00223041     History of Changes
Other Study ID Numbers: 001
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: August 8, 2011
Last Verified: May 2006

Keywords provided by University of Schleswig-Holstein:
renal transplantation
cardiovasculary disease
statin

Additional relevant MeSH terms:
Fluvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors