Trial registered on ANZCTR


Trial ID
ACTRN12609000266268
Ethics application status
Approved
Date submitted
17/02/2009
Date registered
14/05/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
The IDEAL Study: a clinical trial of the timing of kidney dialysis initiation on survival in subjects with chronic kidney disease.
Scientific title
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.
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.
Universal Trial Number (UTN)
Trial acronym
IDEAL Study

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney disease 4344 0
Cardiac disease 4345 0
Nutrition 4346 0
Condition category
Condition code
Renal and Urogenital 4587 4587 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description 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.
Intervention code [1] 4077 0
Treatment: Devices
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.
Control group
Active

Outcomes
Primary outcome [1] 5463 0
All cause mortality
Timepoint [1] 5463 0
At the end of the trial. 800 patients will be followed every 3 months for a minimum of 3 years post randomization.
Secondary outcome [1] 9202 0
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.
Timepoint [1] 9202 0
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.
Secondary outcome [2] 9203 0
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.
Timepoint [2] 9203 0
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.
Secondary outcome [3] 9204 0
Cardiac echo changes that will be studied include:
a) left ventricular mass;
b) systolic function;
c) diastolic function; and
d) myocardial fibrosis.
Timepoint [3] 9204 0
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.
Secondary outcome [4] 9205 0
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.
Timepoint [4] 9205 0
At baseline and then every 12 months for 3 years.

Eligibility
Key inclusion criteria
Age greater than 18 years. Progressive chronic kidney disease. GFR between 10-20ml/min/1.73m^2.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant cancer. Planned live renal transplant in the next 12 months.

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)
Eligible patients are consented and have baseline data collected to confirm inclusion criteria. Central computerized randomization with allocation concealment.
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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy

Recruitment
Anticipated date of first participant enrolment
1/07/2000
Actual date of first participant enrolment
Anticipated date last participant enrolled
Actual date last participant enrolled
Target sample size
800
Actual sample size
Recruitment status
Closed: follow-up complete
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 1575 0
New Zealand
State/province [1] 1575 0

Funding & Sponsors
Funding source category [1] 4516 0
Government body
Name [1] 4516 0
National health and medical research council (NHMRC)
Address [1] 4516 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 4516 0
Australia
Funding source category [2] 4517 0
Government body
Name [2] 4517 0
Australian Health Ministers' Advisory Council (AHMAC)
Address [2] 4517 0
Secretary
The Health, Community and Disability Services Ministerial Council
Post Office Box 344
RUNDLE MALL SA 5000
Country [2] 4517 0
Australia
Funding source category [3] 4518 0
Commercial sector/Industry
Name [3] 4518 0
Baxter Australia
Address [3] 4518 0
One Baxter Drive
Old Toongabbie
NSW, 2146
Country [3] 4518 0
Australia
Funding source category [4] 4519 0
Other Collaborative groups
Name [4] 4519 0
Don and Lorraine Jacquot Fellowship
Australian and New Zealand Society of Nephrology
Address [4] 4519 0
c/o Royal Australian College of Physicians
Macquarie St
Sydney NSW 2000
Country [4] 4519 0
Australia
Funding source category [5] 4520 0
Commercial sector/Industry
Name [5] 4520 0
Amgen Australia
Address [5] 4520 0
Amgen Australia Pty Ltd
Sydney (Head Office)
Level 7, 123 Epping Road
North Ryde, New South Wales, 2113
Country [5] 4520 0
Australia
Funding source category [6] 4521 0
Government body
Name [6] 4521 0
Health Funding Authority New Zealand (Te Mana Putea Hauora O Aotearoa)
Address [6] 4521 0
Health Funding Authority New Zealand.
This no longer exists.
Ministry of Health
PO Box 5013
WELLINGTON 5016
Country [6] 4521 0
New Zealand
Funding source category [7] 4522 0
Charities/Societies/Foundations
Name [7] 4522 0
National Heart Foundation - Australia
Address [7] 4522 0
Level 3, 80 William Street
Sydney NSW 2011
Country [7] 4522 0
Australia
Funding source category [8] 4523 0
Charities/Societies/Foundations
Name [8] 4523 0
National Heart Foundation - New Zealand
Address [8] 4523 0
The National Heart Foundation of New Zealand
P O Box 17-160, Greenlane
9 Kalmia Street, Ellerslie
AUCKLAND 1546
Country [8] 4523 0
New Zealand
Primary sponsor type
Other Collaborative groups
Name
Steering Committee of the IDEAL Study
Address
C/O Dr Bruce Cooper
Department of Renal Medicine
Royal North Shore Hospital
St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 4084 0
None
Name [1] 4084 0
Address [1] 4084 0
Country [1] 4084 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6576 0
Northern Sydney and Central Coast Area Health Service
Ethics committee address [1] 6576 0
Royal North Shore Hospital
St Leonards NSW 2065
Ethics committee country [1] 6576 0
Australia
Date submitted for ethics approval [1] 6576 0
Approval date [1] 6576 0
Ethics approval number [1] 6576 0
0407-156M

Summary
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.
Trial website
https://www.ctru.auckland.ac.nz/ideal/
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.
Public notes

Contacts
Principal investigator
Name 29301 0
Address 29301 0
Country 29301 0
Phone 29301 0
Fax 29301 0
Email 29301 0
Contact person for public queries
Name 12548 0
Dr Bruce A Cooper
Address 12548 0
Department of Renal Medicine
Royal North Shore Hospital
St Leonards NSW 2065
Country 12548 0
Australia
Phone 12548 0
+61 2 9926 8257
Fax 12548 0
+61 2 9926 5484
Email 12548 0
bcooper@med.usyd.edu.au
Contact person for scientific queries
Name 3476 0
Dr Bruce A Cooper
Address 3476 0
Department of Renal Medicine
Royal North Shore Hospital
St Leonards NSW 2065
Country 3476 0
Australia
Phone 3476 0
+61 2 9926 8257
Fax 3476 0
+61 2 9926 5484
Email 3476 0
bcooper@med.usyd.edu.au