Cranoc Lipid Study in Renal Transplantation

Phase 3TerminatedNCT00223041

University Hospital Schleswig-Holstein200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

200

Conditions

Renal Transplantation

Interventions

FluvastatinDRUG

Arm A receives fluvastatin Arm b receives no fluvastatin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Schleswig-Holstein, Campus Kiel, Department of Nephrology

Kiel, Germany

Outcomes

Primary Outcomes

cardivasculary events (cardiovaskulary, cerebrovaskulary, peripher vaskulary)

Time frame: during the study

Secondary Outcomes

patients and kidney survival

Time frame: during the study

amount and typ of rejection (Banff-classifikation)

Time frame: during the study

change in lipids

Time frame: during the study

adverse events of the statin fluvastatin

Time frame: during the study

Data from ClinicalTrials.gov

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