Status:
TERMINATED
Cranoc Lipid Study in Renal Transplantation
Lead Sponsor:
University Hospital Schleswig-Holstein
Conditions:
Renal Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief 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 loo...
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 loo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00223041
Start Date
April 1 2003
End Date
December 1 2010
Last Update
August 8 2011
Active Locations (1)
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1
University of Schleswig-Holstein, Campus Kiel, Department of Nephrology
Kiel, Germany, 24251