Colchicine and Inflammation in Hemodialysis Patients

• Status: Recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assaf-Harofeh Medical Center
• Treatments: Colchicine

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)