Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE)
PHOSPHATE
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.
1 other identifier
interventional
3,600
8 countries
115
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2019
Longer than P75 for not_applicable
115 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2018
CompletedFirst Posted
Study publicly available on registry
June 29, 2018
CompletedStudy Start
First participant enrolled
December 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
July 1, 2025
September 1, 2024
8.1 years
May 20, 2018
June 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to a composite endpoint of cardiovascular death or non-fatal major cardiovascular event
Time to a composite endpoint of cardiovascular death, non-fatal myocardial infarction or coronary revascularization, stroke, or peripheral arterial event.
5 years
Secondary Outcomes (3)
Time to individual components of the primary composite endpoint,
5 years
Time to all-cause death
5 years
Utility-based quality of life EQ5D-5L
5 years
Other Outcomes (8)
Differences in the serum concentrations of phosphate, PTH, calcium, alkaline phosphatase and albumin
Time Frame: 5 years
Phosphate-lowering medication usage
5 years
Phosphate-lowering medication self-reported adherence
5 years
- +5 more other outcomes
Study Arms (2)
Liberal phosphate target
ACTIVE COMPARATORLiberal serum phosphate target of 2.0 to 2.5 mmol/L.
Intensive phosphate target
EXPERIMENTALIntensive serum phosphate target of ≤1.50 mmol/L.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Age ≥45 years, or Age ≥18 years with diabetes,
- ESKD on haemodialysis or peritoneal dialysis, for at least 3 months,
- Currently prescribed at least one phosphate-lowering medication at any dose
- Able to provide informed consent
You may not qualify if:
- Elective kidney transplantation scheduled,
- Concomitant major illness / comorbidity that may result in death in the next 6 months in the view of the treating physician,
- Participation in an interventional study that is likely to affect serum phosphate concentration.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Queenslandlead
- National Health and Medical Research Council, Australiacollaborator
- Applied Health Research Centrecollaborator
- Cambridge University Hospitals NHS Foundation Trustcollaborator
- University of Otagocollaborator
Study Sites (115)
Royal Prince Alfred Hosptial
Camperdown, New South Wales, 2050, Australia
Nepean Hospital
Kingswood, New South Wales, 2750, Australia
St George Hospital
Kogarah, New South Wales, 2217, Australia
Royal North Shore Hospital
Saint Leonards, New South Wales, 2065, Australia
Western Sydney Renal Service
Westmead, New South Wales, 2145, Australia
Wollongong Hospital
Wollongong, New South Wales, 2500, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, 4575, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4006, Australia
Princess Alexandra Hospital
Brisbane, Queensland, 4110, Australia
Bundaberg Hospital
Bundaberg, Queensland, 4670, Australia
Cairns Hospital
Cairns, Queensland, 4870, Australia
Fraser Coast Renal Service
Hervey Bay, Queensland, 4655, Australia
Mackay Hospital
Mackay, Queensland, 4740, Australia
Logan Hospital
Meadowbrook, Queensland, 4131, Australia
Gold Coast University Hospital
Southport, Queensland, 4215, Australia
Townsville University Hospital
Townsville, Queensland, 4817, Australia
Central and Northern Adelaide Renal and Transplant Service
Adelaide, South Australia, 5000, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
Royal Melbourne Hospital
Melbourne, Victoria, 3050, Australia
St Vincent's Hospital Melbourne
Melbourne, Victoria, 3065, Australia
Latrobe Regional Hospital
Traralgon, Victoria, 3844, Australia
Armadale Hospital
Armadale, Washington, 6112, Australia
BRA Santa Casa de Misericórdia de Ponta Grossa
Ponta Grossa, Paraná, 84010-200, Brazil
Sociedade Hospitalar Angelina Caron
Campina Grande, Paraíba, 58407-350, 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, T2N 4Z6, Canada
Alberta Health Services
Edmonton, Alberta, Canada
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Dalhousie University
Halifax, Nova Scotia, B3H 4R2, Canada
Queen's University
Kingston, Ontario, K7L 3N6, Canada
London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
Oakville Trafalgar Memorial Hospital
Oakville, Ontario, L6M 0L8, Canada
Orillia Soldier's Memorial Hospital
Orillia, Ontario, Canada
Lakeridge Health
Oshawa, Ontario, L1G 2B9, Canada
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
Mackenzie Health
Richmond Hill, Ontario, Canada
Scarborough Hospital Network
Scarborough Village, Ontario, M1P 2V5, Canada
St Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
University Health Network - University of Toronto
Toronto, Ontario, M5G 1L7, Canada
St. Joseph's Healthcare Hamilton
Toronto, Ontario, M6R 1B5, Canada
St. Joseph's Healthcare Toronto
Toronto, Ontario, M6R 1B5, Canada
The Charles Lemoyne Hospital
Longueuil, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, 4A 3J1, Canada
Hopital Maisonneuve Rosemont
Montreal, Quebec, H1T 2M4, Canada
CHUM
Montreal, Quebec, H2W 1T8, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Sacre Coeur Hospital
Montreal, Quebec, H4J 1C5, Canada
CHU de Quebec Universite Laval
Québec, Quebec, G1V 4G2, Canada
Centre hospitalier universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec, J1H 5N4, 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, 10400, 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
Related Publications (5)
Edmonston D, Isakova T, Dember LM, Waymyers S, Andersen D, Chan KE, Chakraborty H, Wolf M. Higher versus Lower Phosphate Targets for Patients Undergoing In-Center Hemodialysis: A Randomized Controlled Trial. J Am Soc Nephrol. 2025 Dec 1;36(12):2445-2455. doi: 10.1681/ASN.0000000765. Epub 2025 Jul 10.
PMID: 40638247DERIVEDNatale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
PMID: 40576086DERIVEDFajol A, Faul C. The Pathologic Actions of Phosphate in CKD. Kidney360. 2025 Apr 17;6(6):1040-1049. doi: 10.34067/KID.0000000820.
PMID: 40241437DERIVEDFernandez L, Klein J. Vascular Calcification and CKD: Challenges, Emerging Targets, and Future Perspectives. Clin J Am Soc Nephrol. 2025 Nov 1;20(11):1630-1633. doi: 10.2215/CJN.0000000733. Epub 2025 Apr 16. No abstract available.
PMID: 40238244DERIVEDEdmonston D. Tight Phosphate Control in ESKD Patients Is Warranted: CON. Kidney360. 2024 Dec 13;6(6):895-897. doi: 10.34067/KID.0000000000000401. No abstract available.
PMID: 39671553DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sunil Badve
The University of Queensland
- PRINCIPAL INVESTIGATOR
Ron Wald
St Michael's Hospital
- PRINCIPAL INVESTIGATOR
Rona Smith
University of Cambridge
- PRINCIPAL INVESTIGATOR
Suetonia Green
University of Otago
- PRINCIPAL INVESTIGATOR
Patrick Mark
University of Glasgow
- PRINCIPAL INVESTIGATOR
Rathika Krishnasamy
The University of Queensland
- PRINCIPAL INVESTIGATOR
Michael Walsh
Hamilton Centre for Kidney Research
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2018
First Posted
June 29, 2018
Study Start
December 10, 2019
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2028
Last Updated
July 1, 2025
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 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.
- Access Criteria
- An independent review board will assess proposals based on the following criteria: sound science, benefit-risk balancing and research team expertise.
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.