RecruitingPhase 2ACTRN12617000922370

Inflammation and Colchicine use in patients with ESRF undergoing Dialysis

Understanding the Inflammatory mechanisms and effect of Colchicine in patients with End stage renal failure undergoing Dialysis


Sponsor

A/Prof Sanjay Patel

Enrollment

100 participants

Start Date

Aug 1, 2017

Study Type

Interventional

Conditions

Summary

This study aims to look at the inflammatory processes in patients with kidney disease who require haemodialysis. It has been shown that there is a pro-inflammatory process in this cohort of patients and this study intends to look at the specific mechanisms, immune cellular function and inflammatory molecules involved in this process. It also intends to look at the effect of Colchicine, an anti-inflammatory agent on the level of inflammatory molecules


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at how inflammation works in people with severe kidney disease who are on dialysis, and whether a medicine called colchicine — normally used to treat gout — can reduce that inflammation. People on dialysis often have high levels of inflammation in their blood, which can damage the heart and blood vessels. This study will look at what specific immune cells and molecules are involved, and whether colchicine can lower those levels. You may be eligible if: - You are 18 years old or older - You have end-stage kidney failure and are receiving haemodialysis You may NOT be eligible if: - You are allergic to colchicine - You have moderate or severe liver disease - You have low blood cell counts (thrombocytopenia or leukopenia) - You are pregnant, breastfeeding, or at risk of becoming pregnant - You are taking certain strong medicines that interact with colchicine (CYP3A4 inhibitors) - You are already taking colchicine - You have an active infection or are taking other anti-inflammatory medicines Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Oral Administration of 1mg Colchicine as an initial dose followed by another 0.5mg second dose one hour later. Tablet administration will be performed by healthcare personnel to confirm adherence

Oral Administration of 1mg Colchicine as an initial dose followed by another 0.5mg second dose one hour later. Tablet administration will be performed by healthcare personnel to confirm adherence


Locations(1)

Royal Prince Alfred Hospital - Camperdown

NSW, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12617000922370


Related Trials