Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
200 participants
INTERVENTIONAL
2003-04-30
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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A (therapy with fluvastatin 80mg retard)
kidney transplants receive in addition fluvastatin 80mg retard for 3 years
No interventions assigned to this group
B
no therapy with fluvastatin
Fluvastatin
Arm A receives fluvastatin Arm b receives no fluvastatin
Interventions
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Fluvastatin
Arm A receives fluvastatin Arm b receives no fluvastatin
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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University Hospital Schleswig-Holstein
OTHER
Responsible Party
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University of Kiel, department of Nephrology
Principal Investigators
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Lutz Renders, MD
Role: PRINCIPAL_INVESTIGATOR
University of Scghleswig-Holstein, Campus Kiel, Department of Nephrology
Locations
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University of Schleswig-Holstein, Campus Kiel, Department of Nephrology
Kiel, , Germany
Countries
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Other Identifiers
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001
Identifier Type: -
Identifier Source: org_study_id
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