Colchicine and Inflammation in Hemodialysis Patients

Chronic, low-grade inflammation is regarded as a common comorbid condition in chronic dialysis patients.Increased inflammatory markers in chronic dialysis patients are associated with adverse clinical outcomes .Considering the association of low-grade inflammation with high rate of morbidity and mortality we decided to evaluate the anti inflammatory effect of colchicine on inflammatory markers in hemodialysis patients

Inclusion Criteria:Male or female, age 18-90 years, on MHD hemodialysis treatment at least 3 monthsStable and adequate hemodialysis treatment three months prior to participation in study as defined by Kt/V > 1.2 and/or hemodialysis performed 4 hours 3 times weeklyPatients with serum CRP ≥ 10 mg/LInformed consent obtained before any trial-related activitiesExclusion Criteria:PermCath use as vascular accessAny intake of colchicine for the last three months before recruitmentCritical illness as defined by the need of respiratory or circulatory supportKnown or suspected allergy to colchicineFemales of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using contraceptive methodsPatients with active malignant disease or liver cirrhosis or Severe hepatic disease( defined as ALT or AST levels >3 times upper normal range)Actively symptomatic gastrointestinal bleeding and inflammatory bowel diseaseCRP level above 100 mg/LPatients on chronic treatment with steroids on doses > 10 mg/day Prednisone (or equivalent)Patients treated with immunosuppressive agentsPatients receiving any of the following medications: Astemizole, Cisapride, Pimozide or Terfenadine.Patients suffering from -Acute vasculitis, Severe systemic infections, Severe Heart failure (NYHA class IV), or Mental incapacityAny condition judged by the investigator to interfere with trial participation or evaluation of results or to be potentially hazardous to the patientA significant history of alcohol, drug or solvent abuseHistory of schizophrenia, history of psychiatric hospitalizationunwillingness or language barrierThe receipt of any investigational drug within 1 month prior to initiating of this studyScheduled renal transplantation (fixed date)