Trial from ANZCTR


Trial ID ACTRN12609000266268
Trial Status: Registered
Date Submitted: 17/02/2009
Date Registered: 14/05/2009
Retrospectively registered

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Public title The IDEAL Study: a clinical trial of the timing of kidney dialysis initiation on survival in subjects with chronic kidney disease.
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format Initiating Dialysis Early and Late (IDEAL) Study. A study reviewing the effect of the timing of dialysis initiation on survival in subjects with chronic kidney disease.
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Secondary ID [1] 251670 0
Trial first registered as a publication of the trial protocol in March 2004: Peritoneal Dialysis International, 2004; 24: 176-181.
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UTN
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Trial acronym IDEAL Study
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Health condition(s) or problem(s) studied:
Chronic Kidney disease 4344 0
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Cardiac disease 4345 0
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Nutrition 4346 0
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Condition category: Condition code:
Renal and Urogenital Kidney disease
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4587 4587 0 0

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Descriptions of intervention(s) / exposure Subjects randomized to the Early dialysis initiation: commence dialysis as soon as possible with a target glomerular filtration rate (GFR) of 10-14 ml/min/1.73m^2.
Dialysis type and regimen used (haemodialysis or peritoneal dialysis) is determined by the caring renal physician.
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Intervention Code:
Treatment: Devices 4077 0
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Comparator / control treatment Subjects randomized to the Late dialysis initiation: delay the commencement of dialysis until their GFR is between 5-7 ml/min/1.73m^2.
Dialysis type and regimen used (haemodialysis or peritoneal dialysis) is determined by the caring renal physician.
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Control group Active
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Primary Outcome: All cause mortality 5463 0
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Timepoint: At the end of the trial. 800 patients will be followed every 3 months for a minimum of 3 years post randomization. 5463 0
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Secondary Outcome: Quality of life as measured by using the following research tools:
Health Utilities Index III (HUI III), a multi-attribute generic instrument for measuring quality of life;
Assessment of Quality of Life (AQoL), another multi-attribute generic instrument for measuring quality of life;
Kidney Disease Quality of Life (KDQOL), a disease-specific instrument for measuring quality of life.
9202 0
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Timepoint: Health Utilities Index III (HUI III) is completed by each patient at baseline and every three months thereafter;
Assessment of Quality of Life (AQoL) is also completed by each patient at baseline and every three months thereafter;
Kidney Disease Quality of Life (KDQOL) is completed by each patient at baseline and every 12 months thereafter.
9202 0
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Secondary Outcome: Cost of treatment:
Health Services Utilisation (HSU), an instrument used to collect data on use of hospital resources; and
Patient Diary, an instrument used to collect data on use of community resources.
A separate review of the cost of dialysis in Australia and New Zealand has also been performed and comparisons will also be made with other already published data.
9203 0
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Timepoint: Health Services Utilisation (HSU) is completed for each patient every 3 months after baseline (but not at baseline). This form is completed by the study nurse from the patient's hospital records; and
Patient Diary is completed by each patient each month.
9203 0
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Secondary Outcome: Cardiac echo changes that will be studied include:
a) left ventricular mass;
b) systolic function;
c) diastolic function; and
d) myocardial fibrosis.
9204 0
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Timepoint: Cardiac echo changes will be reviewed in each subject at 0, 6 and 12 months and also just prior to the commencement of dialysis in patients randomized to the late start group. 9204 0
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Secondary Outcome: Nutrition will be assessed using the following measures:
a) Total body nitrogen assessment using prompt neutron activation analysis;
b) Subjective global assessment: a clinical nutrition score;
c) Bioelectrical impedance monitoring; and
c) Serum albumin measurement.
9205 0
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Timepoint: At baseline and then every 12 months for 3 years. 9205 0
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Key inclusion criteria Age greater than 18 years. Progressive chronic kidney disease. GFR between 10-20ml/min/1.73m^2.
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Minimum age 18 Years
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Maximum age No limit
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Gender Both males and females
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Healthy volunteers? No
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Key exclusion criteria Significant cancer. Planned live renal transplant in the next 12 months.
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) Eligible patients are consented and have baseline data collected to confirm inclusion criteria. Central computerized randomization with allocation concealment.
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) Permuted block randomization with stratification for Diabetes, Center and Planned Dialysis Modality.
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Masking / blinding Open (masking not used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Safety/efficacy
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Statistical Methods/Analysis
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Phase Not Applicable
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Anticipated date of first participant enrolment 1/07/2000
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 800
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Recruitment status Closed: follow-up complete
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Recruitment in Australia

Recruitment state(s)
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Recruitment outside Australia

Country: New Zealand 1575 0
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State/Province: 1575 0
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Funding Source: Government body 4516 0
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Name: National health and medical research council (NHMRC) 4516 0
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Address: National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
4516 0
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Country: Australia 4516 0
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Funding Source: Government body 4517 0
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Name: Australian Health Ministers' Advisory Council (AHMAC) 4517 0
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Address: Secretary
The Health, Community and Disability Services Ministerial Council
Post Office Box 344
RUNDLE MALL SA 5000
4517 0
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Country: Australia 4517 0
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Funding Source: Commercial sector/Industry 4518 0
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Name: Baxter Australia 4518 0
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Address: One Baxter Drive
Old Toongabbie
NSW, 2146
4518 0
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Country: Australia 4518 0
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Funding Source: Other Collaborative groups 4519 0
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Name: Don and Lorraine Jacquot Fellowship Australian and New Zealand Society of Nephrology 4519 0
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Address: c/o Royal Australian College of Physicians
Macquarie St
Sydney NSW 2000
4519 0
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Country: Australia 4519 0
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Funding Source: Commercial sector/Industry 4520 0
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Name: Amgen Australia 4520 0
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Address: Amgen Australia Pty Ltd
Sydney (Head Office)
Level 7, 123 Epping Road
North Ryde, New South Wales, 2113
4520 0
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Country: Australia 4520 0
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Funding Source: Government body 4521 0
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Name: Health Funding Authority New Zealand (Te Mana Putea Hauora O Aotearoa) 4521 0
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Address: Health Funding Authority New Zealand.
This no longer exists.
Ministry of Health
PO Box 5013
WELLINGTON 5016
4521 0
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Country: New Zealand 4521 0
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Funding Source: Charities/Societies/Foundations 4522 0
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Name: National Heart Foundation - Australia 4522 0
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Address: Level 3, 80 William Street
Sydney NSW 2011
4522 0
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Country: Australia 4522 0
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Funding Source: Charities/Societies/Foundations 4523 0
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Name: National Heart Foundation - New Zealand 4523 0
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Address: The National Heart Foundation of New Zealand
P O Box 17-160, Greenlane
9 Kalmia Street, Ellerslie
AUCKLAND 1546
4523 0
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Country: New Zealand 4523 0
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Primary Sponsor Other Collaborative groups
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Name: Steering Committee of the IDEAL Study
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Address: C/O Dr Bruce Cooper
Department of Renal Medicine
Royal North Shore Hospital
St Leonards NSW 2065
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Country: Australia
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Secondary Sponsor: None 4084 0
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Name: 4084 0
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Address: 4084 0
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Country: 4084 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Northern Sydney and Central Coast Area Health Service 6576 0
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Address: Royal North Shore Hospital
St Leonards NSW 2065
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Country: Australia 6576 0
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Approval Date: 6576 0
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Submitted Date: 6576 0
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HREC: 0407-156M 6576 0
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Brief summary It has been suggested that dialysis should be commenced early, in subjects with progressive chronic kidney disease, in order to prevent illness and complications however this had never been proven. The IDEAL study was designed to determine when is the best time to commence kidney dialysis for the very first time.
8 Centers are participating in New Zealand.
24 Centers are participating in Australia.
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Trial website https://www.ctru.auckland.ac.nz/ideal/
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Trial related presentations / publications Cooper BA. Branley P. Bulfone L. Collins JF. Craig JC. Dempster J. Fraenkel MB. Harris A. Harris DC. Johnson DW. Kesselhut J. Luxton G. Pilmore A. Pollock CA. Tiller DJ. IDEAL Study Steering Committee. The Initiating Dialysis Early and Late (IDEAL) study: study rationale and design. Peritoneal Dialysis International. 24(2):176-81, 2004 Mar-Apr.
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Dr Bruce A Cooper
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Address: Department of Renal Medicine Royal North Shore Hospital St Leonards NSW 2065
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Country: Australia
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Tel: +61 2 9926 8257
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Fax: +61 2 9926 5484
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Email: bcooper@med.usyd.edu.au
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Contact person for scientific queries
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Name: Dr Bruce A Cooper
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Address: Department of Renal Medicine Royal North Shore Hospital St Leonards NSW 2065
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Country: Australia
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Tel: +61 2 9926 8257
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Fax: +61 2 9926 5484
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Email: bcooper@med.usyd.edu.au
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Contact person responsible for updating information
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Name: Dr Bruce A Cooper
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Address: Department of Renal Medicine Royal North Shore Hospital St Leonards NSW 2065
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Country: Australia
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Tel: +61 2 9926 8257
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Fax: +61 2 9926 5484
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Email: bcooper@med.usyd.edu.au
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Addition Cancer fields
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