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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03573089




Registration number
NCT03573089
Ethics application status
Date submitted
20/05/2018
Date registered
29/06/2018

Titles & IDs
Public title
Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE)
Scientific title
An Investigator-initiated, International, Multi-centre, Prospective, Randomized, Open-label, Parallel-group, Superiority, and Pragmatic Large Simple Trial (LST) to Determine Whether the Currently Recommended Strategy of Intensive Reduction of Serum Phosphate Concentration Towards the Normal Level Results in Significant Patient-centred Benefits in End-stage Kidney Disease (ESKD) Patients Receiving Dialysis.
Secondary ID [1] 0 0
17.02
Universal Trial Number (UTN)
Trial acronym
PHOSPHATE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Failure, Chronic 0 0
Hyperphosphatemia 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Liberal phosphate target
Treatment: Drugs - Intensive phosphate target

Active comparator: Liberal phosphate target - Liberal serum phosphate target of 2.0 to 2.5 mmol/L.

Experimental: Intensive phosphate target - Intensive serum phosphate target of =1.50 mmol/L.


Treatment: Drugs: Liberal phosphate target
All phosphate-lowering medications in use at baseline will be discontinued. Phosphate-lowering medications will be prescribed only if serum phosphate concentration exceeds 2.50 mmol/L. The choice and dosages of phosphate-lowering medications will be at the discretion of treating physicians and/or participants.

Treatment: Drugs: Intensive phosphate target
This will be achieved by prescribing phosphate-lowering medications aimed to intensively lower serum phosphate concentration towards normal level (=1.50 mmol/L). The choice and dosages of phosphate-lowering medications will be at the discretion of treating physicians and/or participants.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to a composite endpoint of cardiovascular death or non-fatal major cardiovascular event
Timepoint [1] 0 0
5 years
Secondary outcome [1] 0 0
Time to individual components of the primary composite endpoint,
Timepoint [1] 0 0
5 years
Secondary outcome [2] 0 0
Time to all-cause death
Timepoint [2] 0 0
5 years
Secondary outcome [3] 0 0
Utility-based quality of life EQ5D-5L
Timepoint [3] 0 0
5 years

Eligibility
Key inclusion criteria
1. Age =45 years, or Age =18 years with diabetes,
2. ESKD on haemodialysis or peritoneal dialysis, for at least 3 months,
3. Currently prescribed at least one phosphate-lowering medication at any dose
4. Able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Elective kidney transplantation scheduled,
2. Concomitant major illness / comorbidity that may result in death in the next 6 months in the view of the treating physician,
3. Participation in an interventional study that is likely to affect serum phosphate concentration.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2028
Actual
Sample size
Target
3600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hosptial - Camperdown
Recruitment hospital [2] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [3] 0 0
St George Hospital - Kogarah
Recruitment hospital [4] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment hospital [5] 0 0
Western Sydney Renal Service - Westmead
Recruitment hospital [6] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [7] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [8] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [9] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [10] 0 0
Bundaberg Hospital - Bundaberg
Recruitment hospital [11] 0 0
Cairns Hospital - Cairns
Recruitment hospital [12] 0 0
Fraser Coast Renal Service - Hervey Bay
Recruitment hospital [13] 0 0
Mackay Hospital - Mackay
Recruitment hospital [14] 0 0
Logan Hospital - Meadowbrook
Recruitment hospital [15] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [16] 0 0
Central and Northern Adelaide Renal and Transplant Service - Adelaide
Recruitment hospital [17] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [18] 0 0
Austin Health - Heidelberg
Recruitment hospital [19] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [20] 0 0
St Vincent's Hospital Melbourne - Melbourne
Recruitment hospital [21] 0 0
Latrobe Regional Hospital - Traralgon
Recruitment hospital [22] 0 0
Armadale Hospital - Armadale
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2750 - Kingswood
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
2500 - Wollongong
Recruitment postcode(s) [7] 0 0
4575 - Birtinya
Recruitment postcode(s) [8] 0 0
4006 - Brisbane
Recruitment postcode(s) [9] 0 0
4110 - Brisbane
Recruitment postcode(s) [10] 0 0
4670 - Bundaberg
Recruitment postcode(s) [11] 0 0
4870 - Cairns
Recruitment postcode(s) [12] 0 0
4655 - Hervey Bay
Recruitment postcode(s) [13] 0 0
4740 - Mackay
Recruitment postcode(s) [14] 0 0
4131 - Meadowbrook
Recruitment postcode(s) [15] 0 0
4215 - Southport
Recruitment postcode(s) [16] 0 0
5000 - Adelaide
Recruitment postcode(s) [17] 0 0
5042 - Bedford Park
Recruitment postcode(s) [18] 0 0
3084 - Heidelberg
Recruitment postcode(s) [19] 0 0
3050 - Melbourne
Recruitment postcode(s) [20] 0 0
3065 - Melbourne
Recruitment postcode(s) [21] 0 0
3844 - Traralgon
Recruitment postcode(s) [22] 0 0
6112 - Armadale
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Paraíba
Country [2] 0 0
Brazil
State/province [2] 0 0
Rio Grande Do Sul
Country [3] 0 0
Canada
State/province [3] 0 0
Alberta
Country [4] 0 0
Canada
State/province [4] 0 0
British Columbia
Country [5] 0 0
Canada
State/province [5] 0 0
Nova Scotia
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec
Country [8] 0 0
New Zealand
State/province [8] 0 0
Auckland
Country [9] 0 0
New Zealand
State/province [9] 0 0
Christchurch
Country [10] 0 0
New Zealand
State/province [10] 0 0
Dunedin
Country [11] 0 0
New Zealand
State/province [11] 0 0
Hamilton
Country [12] 0 0
New Zealand
State/province [12] 0 0
Hastings
Country [13] 0 0
New Zealand
State/province [13] 0 0
Otahuhu
Country [14] 0 0
New Zealand
State/province [14] 0 0
Takapuna
Country [15] 0 0
New Zealand
State/province [15] 0 0
Whangarei
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Cambridgeshire
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Devon
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Dorset
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Durham
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Hertfordshire
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Kent
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Norfolk
Country [23] 0 0
United Kingdom
State/province [23] 0 0
North Lanarkshire
Country [24] 0 0
United Kingdom
State/province [24] 0 0
North Yorkshire
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Nottinghamshire
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Scotland
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Shropshire
Country [28] 0 0
United Kingdom
State/province [28] 0 0
South Yorkshire
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Staffordshire
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Suffolk
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Sussex
Country [32] 0 0
United Kingdom
State/province [32] 0 0
West Yorkshire
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Wirral
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Cheltenham
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Exeter
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Leicester
Country [37] 0 0
United Kingdom
State/province [37] 0 0
London
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Manchester
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Newcastle Upon Tyne
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Reading
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Southend-on-Sea

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Applied Health Research Centre
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Cambridge University Hospitals NHS Foundation Trust
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University of Otago
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Sunil Badve
Address 0 0
The University of Queensland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ron Wald
Address 0 0
Country 0 0
Phone 0 0
+1 416-867-3703
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data that underlie the results reported in the primary publication, after deidentification (text, tables, figures and appendices) will be available for individual participant data meta-analysis.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
Beginning 2 years and ending 5 years following main publication. Proposals may be submitted up to 5 years following article publication. After 5 years, the data will be available in our University's data warehouse but without investigator support other than deposited metadata.
Available to whom?
An independent review board will assess proposals based on the following criteria: sound science, benefit-risk balancing and research team expertise.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03573089