Cranoc Lipid Study in Renal Transplantation

• Status: Terminated
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Schleswig-Holstein; University of Schleswig-Holstein
• Treatments: Fluvastatin

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