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Colchicine and Inflammation in Hemodialysis Patients

NCT05677555 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-01-10

No results posted yet for this study

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

Interventions

DRUG

Colchicine 0.5 MG

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.

DRUG

Placebo

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.

Sponsors & Collaborators

  • Assaf-Harofeh Medical Center

    lead OTHER_GOV

Principal Investigators

  • ILIA beberashvili, Professor · Assaf-Harofeh Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2023-02-28
Completion
2023-02-28

Countries

  • Israel

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05677555 on ClinicalTrials.gov