Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000538044
Ethics application status
Approved
Date submitted
5/07/2010
Date registered
5/07/2010
Date last updated
25/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Australian study of the effects of strict potassium restriction on nerve function in patients with chronic kidney disease
Scientific title
Australian study of the effects of strict potassium restriction on neuropathy in chronic kidney disease
Secondary ID [1] 252029 0
none
Universal Trial Number (UTN)
U1111-1115-5119
Trial acronym
AUSSPRINT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stage 3-4 Chronic kidney disease 257574 0
Neuropathy 257700 0
Condition category
Condition code
Neurological 257744 257744 0 0
Other neurological disorders
Renal and Urogenital 257753 257753 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Strict dietary potassium (K+) restriction with Dietitian support - including an initial consultation, 2 week follow-up consultation with fortnightly phone calls for the first 3 months after which the patient will receive a phone call one month and a face to face consultation the next for the remaining months of the total 24 month trial. If serum K+ levels exceed the target of 3.5-4.5mmol/L for more than 2 months dietary advice will be supplemented by an oral solution of resonium (15-30mg per night as prescribed by the treating physician based on the clinical variables) until K+ falls back within normal range.
Intervention code [1] 256668 0
Prevention
Intervention code [2] 256755 0
Treatment: Other
Comparator / control treatment
Routine clinical care involving standard monthly review by renal physician with monthly electrolyte levels, treatment with resonium only if K+ levels exceed 6.0mmol/L.
Control group
Active

Outcomes
Primary outcome [1] 258625 0
The development of neuropathy assessed by the total neuropathy score (0-28 with a higher score indicating worse neuropathy) and the neuropathy symptom score (0-no neuropathy to 3-disabling neuropathy)
Timepoint [1] 258625 0
Every 6 months after randomisation for 2 years
Secondary outcome [1] 264578 0
Peripheral nerve excitability parameters (threshold electrotonus, superexcitability)
Timepoint [1] 264578 0
Every 6 months after randomisation for 2 years
Secondary outcome [2] 264579 0
Sural nerve sensory amplitude (uV) as measured by routine nerve conduction equipment
Timepoint [2] 264579 0
Every 6 months after randomisation for 2 years
Secondary outcome [3] 264580 0
Health related quality of life using the physical function subscale of SF36
Timepoint [3] 264580 0
Every 6 months after randomisation for 2 years
Secondary outcome [4] 264581 0
Handgrip strength by dynamometry
Timepoint [4] 264581 0
Every 6 months after randomisation for 2 years
Secondary outcome [5] 264592 0
Timed 6m walk
Timepoint [5] 264592 0
Every 6 months after randomisation for 2 years

Eligibility
Key inclusion criteria
History of Chronic Kidney Disease (stage 3 or 4), as defined by the estimated glomerular filtration rate.

Monthly attendance for clinical care at Kidney Care Centre, Prince of Wales Hospital.

Able to provide informed consent
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current or past history of dialysis therapy or previous renal transplantation.

Cognitively impaired

Unable to speak and/or understand English

Pregnant

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be performed by the National Health and Medical Research Council (NHMRC) Clinical Trials Centre 24-hour Randomisation Service, based at the University of Sydney.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be stratified according to the severeity of renal failure (stage 3 or 4) and presence or absence of diabetes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/07/2010
Actual
26/08/2010
Date of last participant enrolment
Anticipated
1/12/2012
Actual
23/11/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
47
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257146 0
Government body
Name [1] 257146 0
National Health and Medical Research Council
Country [1] 257146 0
Australia
Primary sponsor type
Individual
Name
Dr Arun Krishnan
Address
University of New South Wales and Institute of Neurological Sciences, Prince of Wales Hospital, Barker Street, Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 256407 0
Individual
Name [1] 256407 0
Prof Matthew Kiernan
Address [1] 256407 0
University of New South Wales and Institute of Neurological Sciences, Prince of Wales Hospital, Barker Street, Randwick NSW 2031
Country [1] 256407 0
Australia
Other collaborator category [1] 1321 0
Individual
Name [1] 1321 0
Prof Bruce Pussell
Address [1] 1321 0
Department of Nephrology
Prince of Wales Hospital
Barker Street, Randwick NSW 2031
Country [1] 1321 0
Australia
Other collaborator category [2] 1323 0
Individual
Name [2] 1323 0
Ms Adrienne Kirby
Address [2] 1323 0
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country [2] 1323 0
Australia
Other collaborator category [3] 1324 0
Individual
Name [3] 1324 0
Ms Margaret Holyday
Address [3] 1324 0
Department of Nutrition and Dietetics
Prince of Wales Hospital
Barker Street Randwick NSW 2031
Country [3] 1324 0
Australia
Other collaborator category [4] 1325 0
Individual
Name [4] 1325 0
Ms Maria Chan
Address [4] 1325 0
Department of Nutrition and Dietetics
St George Hospital
Kogarah NSW 2217
Country [4] 1325 0
Australia
Other collaborator category [5] 1326 0
Individual
Name [5] 1326 0
Dr Cindy Lin
Address [5] 1326 0
University of New South Wales and Institute of Neurological Sciences
Prince of Wales Hospital
Barker Street, Randwick NSW 2031
Country [5] 1326 0
Australia
Other collaborator category [6] 1327 0
Individual
Name [6] 1327 0
Ms Karen Rounsley
Address [6] 1327 0
Department of Nutrition and Dietetics
Prince of Wales Hospital
Barker Street, Randwick NSW 2031
Country [6] 1327 0
Australia
Other collaborator category [7] 1328 0
Individual
Name [7] 1328 0
Ms Ria Arnold
Address [7] 1328 0
Address: University of New South Wales and Institute of Neurological Sciences
Prince of Wales Hospital,
Barker Street, Randwick NSW 2031
Country [7] 1328 0
Australia
Other collaborator category [8] 1329 0
Individual
Name [8] 1329 0
Dr Tim Pianta
Address [8] 1329 0
Department of Nephrology
Prince of Wales Hospital
Barker Street, Randwick NSW 2031
Country [8] 1329 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259190 0
South Eastern Sydney Illawarra Area Health Service
Ethics committee address [1] 259190 0
Ethics committee country [1] 259190 0
Australia
Date submitted for ethics approval [1] 259190 0
Approval date [1] 259190 0
10/05/2010
Ethics approval number [1] 259190 0
1/10/0006

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

Contacts
Principal investigator
Name 31295 0
A/Prof Arun Krishnan
Address 31295 0
Translational Neuroscience Facility
Room 313
Wallace Wurth Building, High St, Randwick
School of Medical Sciences
University of New South Wales 2052
Country 31295 0
Australia
Phone 31295 0
+61 2 93822413
Fax 31295 0
Email 31295 0
[email protected]
Contact person for public queries
Name 14542 0
Arun Krishnan
Address 14542 0
Room 313 Wallace Wurth Building
University of New South Wales Randwick NSW 2052
Country 14542 0
Australia
Phone 14542 0
+61 2 9385 2756
Fax 14542 0
+61 2 9385 3484
Email 14542 0
arun.krishnan.unsw.edu.au
Contact person for scientific queries
Name 5470 0
Arun Krishnan
Address 5470 0
Room 313 Wallace Wurth Building
University of New South Wales Randwick NSW 2052
Country 5470 0
Australia
Phone 5470 0
+61 2 9385 2756
Fax 5470 0
+61 2 9385 3484
Email 5470 0
arun.krishnan.unsw.edu.au

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
SourceTitleYear of PublicationDOI
EmbaseNeurological complications in chronic kidney disease.2016https://dx.doi.org/10.1177/2048004016677687
EmbaseRandomized, controlled trial of the effect of dietary potassium restriction on nerve function in CKD.2017https://dx.doi.org/10.2215/CJN.00670117
N.B. These documents automatically identified may not have been verified by the study sponsor.