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

Inclusion Criteria1

  • Patients with end stage renal failure on haemodialysis

Exclusion Criteria7

  • 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

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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

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