Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000922370
Ethics application status
Approved
Date submitted
28/02/2017
Date registered
26/06/2017
Date last updated
11/06/2019
Date data sharing statement initially provided
11/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Inflammation and Colchicine use in patients with ESRF undergoing Dialysis
Scientific title
Understanding the Inflammatory mechanisms and effect of Colchicine in patients with End stage renal failure undergoing Dialysis
Secondary ID [1] 291300 0
X17-0008
Universal Trial Number (UTN)
U1111-1193-5813
Trial acronym
ICED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 302267 0
Haemodialysis 302268 0
Inflammation 302269 0
Condition category
Condition code
Renal and Urogenital 301861 301861 0 0
Kidney disease
Inflammatory and Immune System 301862 301862 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 297328 0
Treatment: Drugs
Comparator / control treatment
The control arm will be patients on haemodialysis who have not treated with Colchicine
Control group
Active

Outcomes
Primary outcome [1] 301287 0
Monocyte function which will be assessed by cell culture, ELISA, western blot and PCR results
Timepoint [1] 301287 0
1 month post randomisation
Primary outcome [2] 302513 0
Neutrophil function - cell culture, ELISA, western blot and PCR results
Timepoint [2] 302513 0
1 month post randomisation
Secondary outcome [1] 332214 0
Change in total microRNA levels using PCR
Timepoint [1] 332214 0
1 month post randomisation
Secondary outcome [2] 336162 0
Change in inflammatory cytokine levels (IL-1B, IL-6, IL-12, TNF) and CRP by ELISA assays
Timepoint [2] 336162 0
1 month post randomisation

Eligibility
Key inclusion criteria
Patients with end stage renal failure on haemodialysis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be done at a central administration site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed using a computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/07/2017
Actual
1/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7580 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 15474 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 295766 0
Other
Name [1] 295766 0
Heart Research Institute
Country [1] 295766 0
Australia
Primary sponsor type
Individual
Name
A/Prof Sanjay Patel
Address
Department of Cardiology
Royal Prince Alfred Hospital
Missenden Road, Camperdown 2050
New South Wales
Country
Australia
Secondary sponsor category [1] 295766 0
None
Name [1] 295766 0
Address [1] 295766 0
Country [1] 295766 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297064 0
Sydney Local Health District
Ethics committee address [1] 297064 0
Research Ethics and Governance Office
Royal Prince Alfred Hospital
Suite 210A, 100 Carillon Ave. Newtown NSW 2042
Ethics committee country [1] 297064 0
Australia
Date submitted for ethics approval [1] 297064 0
15/03/2017
Approval date [1] 297064 0
18/05/2017
Ethics approval number [1] 297064 0
X17-0008

Summary
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72854 0
A/Prof Sanjay Patel
Address 72854 0
Department of Cardiology
Royal Prince Alfred Hospital
Missenden Road
Camperdown 2050
New South Wales
Country 72854 0
Australia
Phone 72854 0
+612 9515 6111
Fax 72854 0
Email 72854 0
[email protected]
Contact person for public queries
Name 72855 0
Dr Rahul Kurup
Address 72855 0
Department of Cardiology
Royal Prince Alfred Hospital
Missenden Road
Camperdown 2050
New South Wales
Country 72855 0
Australia
Phone 72855 0
+612 9515 6111
Fax 72855 0
Email 72855 0
[email protected]
Contact person for scientific queries
Name 72856 0
Dr Rahul Kurup
Address 72856 0
Department of Cardiology
Royal Prince Alfred Hospital
Missenden Road
Camperdown 2050
New South Wales
Country 72856 0
Australia
Phone 72856 0
+612 9515 6111
Fax 72856 0
Email 72856 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There will be no individual participant


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.