Colchicine and Inflammation in Hemodialysis Patients (CICI-HP)
End Stage Renal Disease on Dialysis
About this trial
This is an interventional treatment trial for End Stage Renal Disease on Dialysis
Eligibility Criteria
Inclusion Criteria: Male or female, age 18-90 years, on MHD hemodialysis treatment at least 3 months Stable 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 weekly Patients with serum CRP ≥ 10 mg/L Informed consent obtained before any trial-related activities Exclusion Criteria: PermCath use as vascular access Any intake of colchicine for the last three months before recruitment Critical illness as defined by the need of respiratory or circulatory support Known or suspected allergy to colchicine Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using contraceptive methods Patients 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 disease CRP level above 100 mg/L Patients on chronic treatment with steroids on doses > 10 mg/day Prednisone (or equivalent) Patients treated with immunosuppressive agents Patients 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 incapacity Any condition judged by the investigator to interfere with trial participation or evaluation of results or to be potentially hazardous to the patient A significant history of alcohol, drug or solvent abuse History of schizophrenia, history of psychiatric hospitalization unwillingness or language barrier The receipt of any investigational drug within 1 month prior to initiating of this study Scheduled renal transplantation (fixed date)
Sites / Locations
- Asaf ha Rofeh, MCRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
colchicine group
placebo group
Treatment with colchicine 0.5 mg
Treatment with matched placebo