Cranoc Lipid Study in Renal Transplantation

Official Title: “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.

Intervention(s) in this Clinical Trial

• Drug: Fluvastatin
  • Arm A receives fluvastatin Arm b receives no fluvastatin

Arms, Groups and Cohorts in this Clinical Trial

• 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

Primary Measures

• cardivasculary events (cardiovaskulary, cerebrovaskulary, peripher vaskulary)
  • Time Frame: during the study
    Safety Issue?: No

Secondary Measures

• patients and kidney survival
  • Time Frame: during the study
    Safety Issue?: Yes
• amount and typ of rejection (Banff-classifikation)
  • Time Frame: during the study
    Safety Issue?: No
• change in lipids
  • Time Frame: during the study
    Safety Issue?: No
• adverse events of the statin fluvastatin
  • Time Frame: during the study
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of Schleswig-Holstein Other

Overall Clinical Trial Officials and Contacts

Lutz Renders, MD Principal Investigator University of Scghleswig-Holstein, Campus Kiel, Department of Nephrology  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00223041

Study ID Number: 001

ClinicalTrials.gov Identifier: NCT00223041

Health Authority: Germany: Federal Institute for Drugs and Medical Devices