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

September 14, 2005
August 4, 2011
April 2003
November 2009   (final data collection date for primary outcome measure)
cardivasculary events (cardiovaskulary, cerebrovaskulary, peripher vaskulary) [ Time Frame: during the study ] [ Designated as safety issue: No ]
cardivasculary events (cardiovaskulary, cerebrovaskulary, peripher vaskulary)
Complete list of historical versions of study NCT00223041 on ClinicalTrials.gov Archive Site
  • 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 ]
  • patients and kidney survival
  • amount and typ of rejection (Banff-classifikation)
  • change in lipids
  • adverse events of the statin fluvastatin
Not Provided
Not Provided
 
Cranoc Lipid Study in Renal Transplantation
Cardiovascular Events in Renal Transplant Recipients With Low LDL-cholesterol Receiving Tacrolimus in Combination With the Statin Fluvastatin

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Renal Transplantation
Drug: Fluvastatin
Arm A receives fluvastatin Arm b receives no fluvastatin
  • 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
    Intervention: Drug: Fluvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
200
December 2010
November 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00223041
001
Yes
L. Renders, University of Kiel, department of Nephrology
University of Schleswig-Holstein
Not Provided
Principal Investigator: Lutz Renders, MD University of Scghleswig-Holstein, Campus Kiel, Department of Nephrology
University of Schleswig-Holstein
May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP