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Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE)
Sponsor: The University of Queensland
Summary
During end-stage kidney disease, clinical guidelines suggest reducing elevated phosphate levels in the blood. However, the effect of lowering blood phosphate levels on important patient-centred outcomes has never been tested. This trial will evaluate whether compared to high levels, lowering blood phosphate levels would reduce death or major events due to heart disease, improve physical health, and be cost-effective.
Official 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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
3600
Start Date
2019-12-10
Completion Date
2028-12-31
Last Updated
2025-07-01
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (115)
Royal Prince Alfred Hosptial
Camperdown, New South Wales, Australia
Nepean Hospital
Kingswood, New South Wales, Australia
St George Hospital
Kogarah, New South Wales, Australia
Royal North Shore Hospital
Saint Leonards, New South Wales, Australia
Western Sydney Renal Service
Westmead, New South Wales, Australia
Wollongong Hospital
Wollongong, New South Wales, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Bundaberg Hospital
Bundaberg, Queensland, Australia
Cairns Hospital
Cairns, Queensland, Australia
Fraser Coast Renal Service
Hervey Bay, Queensland, Australia
Mackay Hospital
Mackay, Queensland, Australia
Logan Hospital
Meadowbrook, Queensland, Australia
Gold Coast University Hospital
Southport, Queensland, Australia
Townsville University Hospital
Townsville, Queensland, Australia
Central and Northern Adelaide Renal and Transplant Service
Adelaide, South Australia, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Austin Health
Heidelberg, Victoria, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
St Vincent's Hospital Melbourne
Melbourne, Victoria, Australia
Latrobe Regional Hospital
Traralgon, Victoria, Australia
Armadale Hospital
Armadale, Washington, Australia
BRA Santa Casa de Misericórdia de Ponta Grossa
Ponta Grossa, Paraná, Brazil
Sociedade Hospitalar Angelina Caron
Campina Grande, Paraíba, Brazil
Hospital de Clinicas Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Fundacao Felice Rosso - Hospital Felicio Rocho
Barro Preto, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, Brazil
Foothills Hospital/ U of Calgary
Calgary, Alberta, Canada
Alberta Health Services
Edmonton, Alberta, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Dalhousie University
Halifax, Nova Scotia, Canada
Queen's University
Kingston, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Oakville Trafalgar Memorial Hospital
Oakville, Ontario, Canada
Orillia Soldier's Memorial Hospital
Orillia, Ontario, Canada
Lakeridge Health
Oshawa, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Mackenzie Health
Richmond Hill, Ontario, Canada
Scarborough Hospital Network
Scarborough Village, Ontario, Canada
St Michael's Hospital
Toronto, Ontario, Canada
University Health Network - University of Toronto
Toronto, Ontario, Canada
St. Joseph's Healthcare Hamilton
Toronto, Ontario, Canada
St. Joseph's Healthcare Toronto
Toronto, Ontario, Canada
The Charles Lemoyne Hospital
Longueuil, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Hopital Maisonneuve Rosemont
Montreal, Quebec, Canada
CHUM
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Sacre Coeur Hospital
Montreal, Quebec, Canada
CHU de Quebec Universite Laval
Québec, Quebec, Canada
Centre hospitalier universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Red Deer Hospital;
Red Deer, Canada
Humber River Hospital
Toronto, Canada
Michael Garron Hospital
Toronto, Canada
Trillium Health Partners
Toronto, Canada
AURA Paris Plaisance
Paris, France
Hadassah University
Jerusalem, Israel
Shaare Zedek Medical Centre
Jerusalem, Israel
Meir Hospital
Kfar Saba, Israel
Sheba Hospital
Ramat Gan, Israel
Auckland City Hospital
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Dunedin Hospital
Dunedin, New Zealand
Waikato DHB
Hamilton, New Zealand
Hawkes Bay Hospital
Hastings, New Zealand
Middlemore Hospital
Otahuhu, New Zealand
Waitematā Hospital
Takapuna, New Zealand
Northland DHB
Whangarei, New Zealand
Ramathibodi Hospital
Bangkok, Khet Ratchathewi, Thailand
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, Devon, United Kingdom
Dorset County Hospital NHS Foundation Trust
Dorchester, Dorset, United Kingdom
South Tyneside And Sunderland NHS Foundation Trust
Sunderland, Durham, United Kingdom
East and North Hertfordshire NHS Trust
Stevenage, Hertfordshire, United Kingdom
East Kent Hospitals University NHS Foundation Trust
Canterbury, Kent, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, Kent, United Kingdom
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, Norfolk, United Kingdom
NHS Lanarkshire
Airdrie, North Lanarkshire, United Kingdom
South Tees Hospitals NHS Foundation Trust
Middlesbrough, North Yorkshire, United Kingdom
York and Scarborough Teaching Hospitals NHS Foundation Trust
York, North Yorkshire, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, United Kingdom
NHS Highland
Inverness, Scotland, United Kingdom
Shrewsbury and Telford Hospital NHS Trust
Shrewsbury, Shropshire, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, United Kingdom
University Hospital of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, United Kingdom
West Suffolk Hospital
Bury St Edmunds, Suffolk, United Kingdom
University Hospitals Sussex NHS Foundation Trust
Brighton, Sussex, United Kingdom
Bradford Teaching Hospital NHS Foundation Trust
Bradford, West Yorkshire, United Kingdom
Wirral University Teaching Hospital NHS Foundation Trust
Birkenhead, Wirral, United Kingdom
University Hospital Birmingham NHS foundation Trust
Birmingham, United Kingdom
Cardiff and Wales University Local Health Board
Cardiff, United Kingdom
North Cumbria Integrated Care NHS Foundation Trust
Carlisle, United Kingdom
Epsom and St Helier University Hospitals NHS Trust
Carshalton, United Kingdom
Gloucestershire Hospital NHS Foundation Trust
Cheltenham, United Kingdom
University Hospitals Coventry & Warwickshire
Coventry, United Kingdom
University Hospitals of Derby and Burton
Derby, United Kingdom
Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
Doncaster, United Kingdom
The Dudley Group NHS Foundation Trust
Dudley, United Kingdom
Royal Devon and Exeter NHS Foundation Trust
Exeter, United Kingdom
Hull University Teaching Hospital NHS Trust
Hull, United Kingdom
Ipswich Hospital (East Suffolk & North Essex Foundation Trust)
Ipswich, United Kingdom
University Hospitals Of Leicester NHS Trust
Leicester, United Kingdom
Royal Liverpool University Hospitals
Liverpool, United Kingdom
University Hospital Aintree
Liverpool, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom
St George's University Hospitals NHS Foundation Trust
London, United Kingdom
Manchester University NHS Foundation Trust
Manchester, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom
Royal Berkshire NHS Foundation Trust
Reading, United Kingdom
Mid and South Essex NHS Foundation Trust
Southend-on-Sea, United Kingdom
The Royal Wolverhampton NHS Trust
Wolverhampton, United Kingdom