Colchicine and Inflammation in Hemodialysis Patients

NCT05677555 | Unknown Phase 2

• 1 other identifier: 9922
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

End Stage Renal Disease on Dialysis

Outcome Measures

Primary Outcomes (2)

• Inflammation assessed by measuring blood levels of inflammatory biomarkers

  Investigate the effect of colchicine on the level inflammation blood biomarkers (C- reactive protein -CRP, IL-6, TNF-a) of adult patients on maintenance hemodialysis (MHD)

  3 months

• Incidence of treatment emergent adverse events as assessed by routine clinical and blood tests monitoring

  In each visit (every month) participants will be interview for every change in their clinical status including specific known adverse events of colchicine (such as diarrhea , neuropathy, fever, muscle weakness). moreover, blood tests will be drawn for complete blood count and chemistry. physical examination will be carried out at ehch visit.

  3 months

Secondary Outcomes (11)

• Nutritional score- VAS - visual analog scale

  3 months

• Quality of life score-SF-36- "36 item short form survey"

  3 months

• Body composition by bioimpedance-lean body mass

  3 months

• NUTRITIONAL SCORE- ADAT- appetite and diet assessment tool

  3 MONTHS

• NUTRITIONAL SCORE- OSND- objective score of nutrition on dialysis

  3 MONTHS

Study Arms (2)

colchicine group

EXPERIMENTAL

Treatment with colchicine 0.5 mg

Drug: Colchicine 0.5 MG

placebo group

PLACEBO COMPARATOR

Treatment with matched placebo

Drug: Placebo

Interventions

Colchicine 0.5 MG DRUG

A total of 25 subjects will be randomized to treatment with COLCHICINE 0.5 mg, three times a week (at the end of each hemodialysis session) over the 3 month study period.

colchicine group

Placebo DRUG

A total of 25 subjects will be randomized to treatment with matched placebo, three times a week (at the end of each hemodialysis session) over the 3 month study period.

placebo group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Asaf ha Rofeh, MC

Zrifin, 70300, Israel

RECRUITING

MeSH Terms

Interventions

Colchicine

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• ILIA beberashvili, Professor

  Assaf-Harofeh Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ILIA beberashvili, Professor

CONTACT

972-53-7346133; iliab@shamir.gov.il

ELAD nizri, Dr.

CONTACT

972-50-2932222; nizrielad@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of dialysis department

Study Record Dates

• First Submitted: September 10, 2022
• First Posted: January 10, 2023
• Study Start: November 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: January 10, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available at the end of study period (after the last follow up visit - about 3 months period), and for one year thereafter.

Locations

IL (1)