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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014