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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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000922370
Acronym
ICED
Enrollment
3
Registered
2017-06-26
Start date
2017-08-01
Completion date
Unknown
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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

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

Sponsors

A/Prof Sanjay Patel
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients with end stage renal failure on haemodialysis

Exclusion criteria

Known hypersensitivity to colchicine Moderate hepatic dysfunction (Alanine Aminotransferase 1.5x upper limit of normal range) Thrombocytopaenia or leukopaenia Pregnant or lactating women and women at risk of pregnancy Patients taking moderate-strong CYP3A4 inhibitors Patients already taking Colchicine Those with evidence of active infection of inflammatory conditions that might be associated with markedly elevated CRP levels in the blood and those taking other anti-inflammatory therapies

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026