Cranoc Lipid Study in Renal Transplantation

Phase 2

Terminated

• Conditions: Renal Transplantation
• Interventions: Drug: Fluvastatin

• Registration Number: NCT00223041
• Lead Sponsor: University Hospital Schleswig-Holstein

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 look for the cardiovascular outcome with and without statins.

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.

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-22
• Status Verified: 2006-05
• Primary Completion: 2009-11
• Study Completion: 2010-12
• Last Update Submitted: 2011-08-04
• Last Update Posted: 2011-08-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Fluvastatin	no therapy with fluvastatin

Primary Outcome Measures

Name	Time	Method
cardivasculary events (cardiovaskulary, cerebrovaskulary, peripher vaskulary)	during the study

Secondary Outcome Measures

Name	Time	Method
patients and kidney survival	during the study
amount and typ of rejection (Banff-classifikation)	during the study
change in lipids	during the study
adverse events of the statin fluvastatin	during the study

Trial Locations

Locations (1)

University of Schleswig-Holstein, Campus Kiel, Department of Nephrology; 🇩🇪 Kiel, Germany