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Cranoc Lipid Study in Renal Transplantation

This study has been terminated.
(No possibilty to receive all plened patients for this study)
Sponsor:
Information provided by:
University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT00223041
First received: September 14, 2005
Last updated: August 4, 2011
Last verified: May 2006
History of Changes
  Purpose

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 Intervention Phase
Renal Transplantation
 Drug: Fluvastatin
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:
  • cardivasculary events (cardiovaskulary, cerebrovaskulary, peripher vaskulary) [ Time Frame: during the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • patients and kidney survival [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
  • amount and typ of rejection (Banff-classifikation) [ Time Frame: during the study ] [ Designated as safety issue: No ]
  • change in lipids [ Time Frame: during the study ] [ Designated as safety issue: No ]
  • adverse events of the statin fluvastatin [ Time Frame: during the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: April 2003
Study Completion Date: December 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: L. Renders, University of Kiel, department of Nephrology
ClinicalTrials.gov Identifier: NCT00223041     History of Changes
Other Study ID Numbers: 001
Study First Received: September 14, 2005
Last Updated: August 4, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on May 23, 2013