Inflammation and Colchicine use in patients with ESRF undergoing Dialysis

Phase 1

Recruiting

• Conditions: Chronic Kidney Disease; Haemodialysis; Inflammation; Renal and Urogenital - Kidney disease; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12617000922370
• Lead Sponsor: A/Prof Sanjay Patel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-26
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Monocyte function which will be assessed by cell culture, ELISA, western blot and PCR results[1 month post randomisation];Neutrophil function - cell culture, ELISA, western blot and PCR results[1 month post randomisation]

Secondary Outcome Measures

Name	Time	Method
Change in total microRNA levels using PCR[1 month post randomisation];Change in inflammatory cytokine levels (IL-1B, IL-6, IL-12, TNF) and CRP by ELISA assays[1 month post randomisation]