Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000760875
Ethics application status
Approved
Date submitted
3/07/2012
Date registered
17/07/2012
Date last updated
17/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
UREMIC TOXIN: Utility in REnal disease of Measuring Indoxyl sulphate and p-Cresyl sulphate To predict OXidative stress, Inflammation and cliNical outcomes
Scientific title
A retrospective cross-sectional/longitudinal observational study looking at the concentration of uremic toxins with poor outcomes in patients with Chronic Kidney Disease Stage 1-5
Secondary ID [1] 280774 0
Nil
Universal Trial Number (UTN)
U1111-1132-3596
Trial acronym
Uremic Toxin
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 286833 0
Cardiovascular disease 286932 0
Condition category
Condition code
Renal and Urogenital 287142 287142 0 0
Kidney disease
Cardiovascular 287263 287263 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Chronic Kidney Disease level of uremic toxins (serum analysis), CVD biomarkers (arterial stiffness by aortic pulse-wave velocity (PWV); atheroma burden by carotid intima-media thickness (cIMT) and endothelial function by flow-mediated dilation (FMD) of the brachial artery), and inflammation (serum markers) for two years.

All of the above will be performed at three time points baselines, 1 year and 2 year.
Intervention code [1] 285200 0
Not applicable
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287455 0
Indoxyl sulphate concentration (mg/L) (serum analysis)
Timepoint [1] 287455 0
baseline, year 1, year 2
Primary outcome [2] 287542 0
P-cresyl sulphate concentration (mg/L) (serum analysis)
Timepoint [2] 287542 0
baseline, year 1, year 2
Secondary outcome [1] 298188 0
Cardiovascular risk factors- arterial stiffness by aortic pulse-wave velocity (PWV); atheroma burden by carotid intima-media thickness (cIMT) and endothelial function by flow-mediated dilation (FMD) of the brachial artery.
Timepoint [1] 298188 0
baseline, year 1, year 2
Secondary outcome [2] 298356 0
Mortality- all cause and cardiovascular (death registry)
Timepoint [2] 298356 0
study duration ie. 0-2 years
Secondary outcome [3] 298357 0
Kidney Function- serum creatinine (serum analysis), urinary protein (mid stream urinary analysis)
Timepoint [3] 298357 0
baseline, year 1, year 2
Secondary outcome [4] 298358 0
Inflammation- C-Reactive Protein, Interleukin-6 (serum analysis)
Timepoint [4] 298358 0
baseline, year 1, year 2

Eligibility
Key inclusion criteria
Chronic Kidney Disease (CKD) (stage1-5D)
>/= 18 years
Able to provide informed consent
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non CKD
Unable/unwilling to give informed consent
Unable/unwilling to comply with frequent follow-up
Life expectancy was severely limited due to pre-existing malignancy or other disease (<6 months)
Pregnancy

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285560 0
Hospital
Name [1] 285560 0
Princess Alexandra Hospital
Country [1] 285560 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
199 Ipswich Rd Woolloongabba, Brisbane, Queensland 4102
Country
Australia
Secondary sponsor category [1] 284397 0
None
Name [1] 284397 0
Address [1] 284397 0
Country [1] 284397 0
Other collaborator category [1] 276901 0
University
Name [1] 276901 0
University of Queensland
Address [1] 276901 0
Mansfield Place St Lucia, Brisbane, Queensland 4072
Country [1] 276901 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287576 0
Metro South Hospital and Health Service
Ethics committee address [1] 287576 0
Ethics committee country [1] 287576 0
Australia
Date submitted for ethics approval [1] 287576 0
Approval date [1] 287576 0
04/05/2012
Ethics approval number [1] 287576 0
HREC/12/QPAH/216

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34390 0
Address 34390 0
Country 34390 0
Phone 34390 0
Fax 34390 0
Email 34390 0
Contact person for public queries
Name 17637 0
Megan Rossi
Address 17637 0
ARTs Building 31, 2nd Floor Nephrology Building.
199 Ipswich Rd, Brisbane, Queensland 4102
Country 17637 0
Australia
Phone 17637 0
+614 02931441
Fax 17637 0
+61 7 3176 5480
Email 17637 0
[email protected]
Contact person for scientific queries
Name 8565 0
Megan Rossi
Address 8565 0
ARTs Building 31, 2nd Floor Nephrology Building.
199 Ipswich Rd, Brisbane, Queensland 4102
Country 8565 0
Australia
Phone 8565 0
+614 02931441
Fax 8565 0
+61 7 3176 5480
Email 8565 0
[email protected]

No information has been provided regarding IPD availability


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.