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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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Address [1] 285560 0
199 Ipswich Rd Woolloongabba, Brisbane, Queensland 4102
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
199 Ipswich Rd, Woolloongabba, Brisbane, Queensland 4102
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
The roles of indoxyl sulphate and p-cresyl sulphate as nephro- and cardiovascular toxins has recently gained recognition, although their true association and mechanisms behind their putative deleterious actions are yet to be investigated in human studies.
The aim of this observational study is to gain a better understanding of the associations between these two protein-bound uremic toxins, IS and PCS, and Cardio Vascular Disease (CVD) and CKD progression, along with other poor outcomes seen in CKD. A secondary
aim is to determine whether live kidney donors post nephrectomy have an increase concentration of these toxins and any association with morbidity in this population.
Trial website
Trial related presentations / publications
Rossi M, Klein K, Johnson DW, and Campbell KL. (2012).Pre-, Pro- & Synbiotics: Do they have a role in reducing uremic toxins? A systematic review and Meta analysis. British Journal of Nutrition (under review)
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
megan_rossi@msn.com
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
megan_rossi@msn.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary