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Clinical Trials/NCT00223041
NCT00223041
Terminated
Phase 2

Cardiovascular Events in Renal Transplant Recipients With Low LDL-cholesterol Receiving Tacrolimus in Combination With the Statin Fluvastatin

University Hospital Schleswig-Holstein1 site in 1 country200 target enrollmentApril 2003
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ConditionsRenal Transplantation
InterventionsFluvastatin
DrugsFluvastatin

Overview

Phase
Phase 2
Intervention
Fluvastatin
Conditions
Renal Transplantation
Sponsor
University Hospital Schleswig-Holstein
Enrollment
200
Locations
1
Primary Endpoint
cardivasculary events (cardiovaskulary, cerebrovaskulary, peripher vaskulary)
Status
Terminated
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
April 2003
End Date
December 2010
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital Schleswig-Holstein

Eligibility Criteria

Inclusion Criteria

  • •patients (18 - 65, inclusive)
  • •cadaver and living kidney transplantation (
  • •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

Arms & Interventions

B

no therapy with fluvastatin

Intervention: Fluvastatin

Outcomes

Primary Outcomes

cardivasculary events (cardiovaskulary, cerebrovaskulary, peripher vaskulary)

Time Frame: during the study

Secondary Outcomes

  • patients and kidney survival(during the study)
  • amount and typ of rejection (Banff-classifikation)(during the study)
  • change in lipids(during the study)
  • adverse events of the statin fluvastatin(during the study)

Study Sites (1)

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