Kidney Failure, ChronicPHOSPHATENCT03573089
Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE)
A study testing Liberal phosphate target and Intensive phosphate target in people with Kidney Failure, Chronic and Hyperphosphatemia, run by The University of Queensland at 126 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic, Hyperphosphatemia
- What is being tested?
- Liberal phosphate target and Intensive phosphate target
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,600 participants
- Where
- 126 sitesin 9 countries
- Study dates
- 10 Dec 2019to 31 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
126 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
126 sites in 9 countries
United Kingdom46 sites, 46 recruiting
- Recruiting
NHS Lanarkshire
Airdrie, North Lanarkshire
Zoe Cousland, Dr
- Recruiting
Wirral University Teaching Hospital NHS Foundation Trust
Birkenhead, Wirral
Tom Ledson, Dr
- Recruiting
University Hospital Birmingham NHS foundation Trust
Birmingham
Kolitha Basnayake, Dr
- Recruiting
Bradford Teaching Hospital NHS Foundation Trust
Bradford, West Yorkshire
Tarun Bansai, Dr
- Recruiting
University Hospitals Sussex NHS Foundation Trust
Brighton, Sussex
Farid Ghalli, Dr
- Recruiting
West Suffolk Hospital
Bury St Edmunds, Suffolk
Nicholas Pritchard, Dr
- Recruiting
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire
Nicholas Pritchard, Dr
- Recruiting
East Kent Hospitals University NHS Foundation Trust
Canterbury, Kent
Mike Delaney, Dr
- Recruiting
Cardiff and Wales University Local Health Board
Cardiff
Rhodri Pyart, Dr
- Recruiting
North Cumbria Integrated Care NHS Foundation Trust
Carlisle
Amer Hayat, Dr
- Recruiting
Epsom and St Helier University Hospitals NHS Trust
Carshalton
Pauline Swift, Dr
- Recruiting
Gloucestershire Hospital NHS Foundation Trust
Cheltenham
Madhu Potluri, Dr
- Recruiting
Portsmouth Hospitals University NHS Trust
Cosham
Katey Flowers, Dr
- Recruiting
University Hospitals Coventry & Warwickshire
Coventry
Waqar Ayub, Dr
- Recruiting
University Hospitals of Derby and Burton
Derby
Nitin Kolhe, Dr
- Recruiting
Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
Doncaster
Ian Stott, Dr
- Recruiting
Dorset County Hospital NHS Foundation Trust
Dorchester, Dorset
Joanne Taylor, Dr
- Recruiting
The Dudley Group NHS Foundation Trust
Dudley
Kunigal Shivakumar, Dr
- Recruiting
Royal Devon and Exeter NHS Foundation Trust
Exeter
Coralie Bingham, Dr
- Recruiting
NHS Greater Glasgow and Clyde
Glasgow, Kent
Sokratis Stoumpos, Dr
- Recruiting
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, Norfolk
Jean Patrick, Dr
- Recruiting
Hull University Teaching Hospital NHS Trust
Hull
Sunil Bhandari, Dr
- Recruiting
NHS Highland
Inverness, Scotland
Stewart Lambie, Dr
- Recruiting
Ipswich Hospital (East Suffolk & North Essex Foundation Trust)
Ipswich
Richard Smith, Dr
- Recruiting
NHS Ayrshire and Arran
Kilmarnock, Scotland
Vishal Dey, vishal.dey@nhs.net
- Recruiting
University Hospitals Of Leicester NHS Trust
Leicester
James Burton, Dr
- Recruiting
Royal Liverpool University Hospitals
Liverpool
Anirudh Rao, Dr
- Recruiting
University Hospital Aintree
Liverpool
Christopher Glodsmith, Dr
- Recruiting
Guy's and St Thomas' NHS Foundation Trust
London
Mike Robson, Dr
- Recruiting
King's College Hospital NHS Foundation Trust
London
Helen Alston, Dr
- Recruiting
St George's University Hospitals NHS Foundation Trust
London
Vasantha Muthuppalaniappan, Dr
- Recruiting
Manchester University NHS Foundation Trust
Manchester
Sandip Mitra, Prof
- Recruiting
South Tees Hospitals NHS Foundation Trust
Middlesbrough, North Yorkshire
Neil Hoye, Dr
- Recruiting
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne
Suren Kanagasundaram, Dr
- Recruiting
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire
Charlotte Bebb, Dr
- Recruiting
University Hospitals Plymouth NHS Trust
Plymouth, Devon
Hilary Cramp, Dr
- Recruiting
Royal Berkshire NHS Foundation Trust
Reading
Bassam Alchi, Dr
- Recruiting
Salford Royal NHS Foundation Trust
Salford
Maharajan Raman
- Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire
Simon Curran, Dr
- Recruiting
Shrewsbury and Telford Hospital NHS Trust
Shrewsbury, Shropshire
Kevin Eardley, Dr
- Recruiting
Mid and South Essex NHS Foundation Trust
Southend-on-Sea
Anthony Yin Keet Chan, Dr
- Recruiting
East and North Hertfordshire NHS Trust
Stevenage, Hertfordshire
Enric Vilar, Dr
- Recruiting
University Hospital of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire
Madhavan Menon, Dr
- Recruiting
South Tyneside And Sunderland NHS Foundation Trust
Sunderland, Durham
Rachel Davison, Dr
- Recruiting
The Royal Wolverhampton NHS Trust
Wolverhampton
Kay Tan, Dr
- Recruiting
York and Scarborough Teaching Hospitals NHS Foundation Trust
York, North Yorkshire
Santhanakrishnan Balasubramanian, Dr
Canada33 sites, 32 recruiting
- Recruiting
Foothills Hospital/ U of Calgary
Calgary, Alberta, T2N 4Z6
Louis Girard, Louis.girard@albertahealthservices.ca
- Recruiting
Alberta Health Services
Edmonton, Alberta
David Collister
- Recruiting
Dalhousie University
Halifax, Nova Scotia, B3H 4R2
Karthik Tennankore, KarthikK.tennankore@nshealth.ca
- Recruiting
Queen's University
Kingston, Ontario, K7L 3N6
Samuel Silver, Samuel.silver@queensu.ca
- Recruiting
London Health Sciences Centre
London, Ontario, N6A 5W9
Matthew Weir, Matthew.weir@lhsc.on.ca
- Recruiting
The Charles Lemoyne Hospital
Longueuil, Quebec
Dominic Poirier, Dr
- Recruiting
McGill University Health Centre
Montreal, Quebec, 4A 3J1
Rita Suri, Rsuri.kidney@gmail.com
- Recruiting
Hopital Maisonneuve Rosemont
Montreal, Quebec, H1T 2M4
Annie-Claire Nadeau-Fredette, acnadeau-fredette.hmr@ssss.gouv.qc.ca
- Recruiting
CHUM
Montreal, Quebec, H2W 1T8
William Beaubien, william.beaubien@gmail.com
Marie-Line Caron, marie-line.caron.chum@ssss.gouv.qc.ca
- Recruiting
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Daniel Blum, Daniel.blum@mail.mcgill.ca
- Recruiting
Sacre Coeur Hospital
Montreal, Quebec, H4J 1C5
Remi Goupil, remi.goupil@umontreal.ca
- Recruiting
Sunnybrook Health Sciences Centre
North York, Ontario, M4N 3M5
Ayodele Odutayo, Dr, ayodele.odutayo@mail.utoronto.ca
- Recruiting
Oakville Trafalgar Memorial Hospital
Oakville, Ontario, L6M 0L8
Danny Sapir, dsapir@haltonhealthcare.com
- Recruiting
Orillia Soldier's Memorial Hospital
Orillia, Ontario
Daniel Tascona, Dr
- Recruiting
Lakeridge Health
Oshawa, Ontario, L1G 2B9
Andrew Steele, asteele@lh.ca
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Swapnil Hiremath, shiremath@toh.ca
- Recruiting
CHU de Quebec Universite Laval
Québec, Quebec, G1V 4G2
Fabrice Mac-Way, Fabrice.mac-way@chudequebec.ca
- Recruiting
Red Deer Hospital;
Red Deer
Sandeep Brar
- Recruiting
Prairie Vascular Research Inc
Regina, Saskatchewan, S4P 0W5
Bhanu Prasad, Dr, secy.drprasad@sasktel.net
- Recruiting
Mackenzie Health
Richmond Hill, Ontario
- Recruiting
Scarborough Hospital Network
Scarborough Village, Ontario, M1P 2V5
Paul Tam, pywtam@gmail.com
- Recruiting
Centre hospitalier universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec, J1H 5N4
Martin Plaisance
- Recruiting
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec
Martin Plaisance, Dr
- Recruiting
St Michael's Hospital
Toronto, Ontario, M5B 1W8
Ron Wald, Dr, 416-867-3703, Ron Wald <Ron.Wald@unityhealth.to>
- Recruiting
University Health Network - University of Toronto
Toronto, Ontario, M5G 1L7
Charmaine Lok, charmaine.lok@uhn.ca
- Recruiting
St. Joseph's Healthcare Hamilton
Toronto, Ontario, M6R 1B5
Michael Walsh, Dr, 905-522-1155 ext. 34055, lastwalsh1975@gmail.com
- Recruiting
St. Joseph's Healthcare Toronto
Toronto, Ontario, M6R 1B5
Joanna Sasal, Joanna.sasal@unityhealth.to
- Recruiting
Humber River Hospital
Toronto
Gihad Nesrallah
- Recruiting
Michael Garron Hospital
Toronto
Nausheen Siddiqui
- Recruiting
Trillium Health Partners
Toronto
Vincent Ki
- Recruiting
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Mercedech Kiaii, mkiaii@providencehealth.bc.ca
- Completed
Vancouver General Hospital
Vancouver, British Columbia
- Recruiting
St. Boniface General Hospital
Winnipeg, Manitoba
Alex Meraz-Munoz, Dr, amerazmunoz@sbgh.mb.ca
Australia23 sites
- Completed
Central and Northern Adelaide Renal and Transplant Service
Adelaide, South Australia, 5000
- Completed
Armadale Hospital
Armadale, Washington, 6112
- Completed
Flinders Medical Centre
Bedford Park, South Australia, 5042
- Completed
Sunshine Coast University Hospital
Birtinya, Queensland, 4575
- Completed
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4006
- Completed
Princess Alexandra Hospital
Brisbane, Queensland, 4110
- Completed
Bundaberg Hospital
Bundaberg, Queensland, 4670
- Completed
Cairns Hospital
Cairns, Queensland, 4870
- Completed
Royal Prince Alfred Hosptial
Camperdown, New South Wales, 2050
- Completed
Austin Health
Heidelberg, Victoria, 3084
- Completed
Fraser Coast Renal Service
Hervey Bay, Queensland, 4655
- Completed
Nepean Hospital
Kingswood, New South Wales, 2750
- Completed
St George Hospital
Kogarah, New South Wales, 2217
- Completed
Mackay Hospital
Mackay, Queensland, 4740
- Completed
Logan Hospital
Meadowbrook, Queensland, 4131
- Completed
Royal Melbourne Hospital
Melbourne, Victoria, 3050
- Completed
St Vincent's Hospital Melbourne
Melbourne, Victoria, 3065
- Completed
Royal North Shore Hospital
Saint Leonards, New South Wales, 2065
- Completed
Gold Coast University Hospital
Southport, Queensland, 4215
- Completed
Townsville University Hospital
Townsville, Queensland, 4817
- Completed
Latrobe Regional Hospital
Traralgon, Victoria, 3844
- Completed
Western Sydney Renal Service
Westmead, New South Wales, 2145
- Completed
Wollongong Hospital
Wollongong, New South Wales, 2500
New Zealand8 sites
- Completed
Auckland City Hospital
Auckland
- Completed
Christchurch Hospital
Christchurch
- Completed
Dunedin Hospital
Dunedin
- Completed
Waikato DHB
Hamilton
- Completed
Hawkes Bay Hospital
Hastings
- Completed
Middlemore Hospital
Otahuhu
- Completed
Waitematā Hospital
Takapuna
- Completed
Northland DHB
Whangarei
Brazil6 sites, 6 recruiting
- Recruiting
Fundacao Felice Rosso - Hospital Felicio Rocho
Barro Preto
Lucas Filogonio
- Recruiting
Sociedade Hospitalar Angelina Caron
Campina Grande, Paraíba, 58407-350
Dalton Bertolin Precoma
- Recruiting
BRA Santa Casa de Misericórdia de Ponta Grossa
Ponta Grossa, Paraná, 84010-200
- Recruiting
Hospital de Clinicas Porto Alegre
Porto Alegre, Rio Grande do Sul
Fernando Saldanha Thome, Dr, fthome@hcpa.edu.br
- Recruiting
Hospital Alemao Oswaldo Cruz
São Paulo
Precil Diego M. de M. Neves
- Recruiting
Serviço Ubaense de Nefrologia Ltda
Ubá, Minas Gerais
Ricardo Furtado, Dr, r.furtado@nefrosun.com.br
Israel5 sites, 5 recruiting
- Recruiting
Hadassah University
Jerusalem
Eyal Ophir
- Recruiting
Shaare Zedek Medical Centre
Jerusalem
Linda Shavit
- Recruiting
Meir Hospital
Kfar Saba
Keren Cohen
- Recruiting
Sheba Hospital
Ramat Gan
Pazit Beckerman
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv
Singapore3 sites, 3 recruiting
- Recruiting
Khoo Teck Puat Hospital
Singapore
Allen Liu Yan Lun, liu.allen.yl@nhghealth.com.sg
- Recruiting
Tan Tock Seng Hospital Pte. Ltd.
Singapore
Benjamin Khoo Zhi En, benjamin.za.khoo@nhghealth.com.sg
- Recruiting
Woodlands Health
Singapore
Ibakkanavar Rajiva Guddappa, rajiva.guddappa.ibakkanavar@nhghealth.com.sg
Thailand1 site, 1 recruiting
- Recruiting
Ramathibodi Hospital
Bangkok, Khet Ratchathewi, 10400
Sinee Disthabanchong, Professor, sinee.dis@mahidol.edu
About this study
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.
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.
Read the detailed description
Hyperphosphataemia is highly prevalent in patients with end-stage kidney disease (ESKD) and associated with increased mortality risk. The Clinical Practice Guidelines suggest lowering elevated phosphate levels towards the normal range (level 2C suggestion). However, trial data demonstrating that treatments that lower serum phosphate will improve patient-centred outcomes are lacking.
The primary objective is to test the hypothesis that compared to a liberal serum phosphate concentration target of 2.0 to 2.5 mmol/L, intensive lowering of serum phosphate towards the normal level (≤1.50 mmol/L) with phosphate binders reduces the risk of fatal or non-fatal major cardiovascular events in ESKD patients receiving dialysis. The secondary objectives are to test the hypothesis that intensive lowering of serum phosphate towards the normal level with phosphate binders would improve physical health, fatigue, health-related quality of life, patient satisfaction, and pruritus; and be cost-effective.
In this pragmatic, multinational, randomised controlled large simple trial, a total of 3600 adult ESKD patients receiving dialysis will be randomised either to intensive (≤1.50 mmol/L) or liberalized (2.0-2.5 mmol/L) serum phosphate target. The choice and dose of phosphate binders will be at the treating physician's discretion and local practice to achieve and maintain serum phosphate concentration within the required target range according to randomisation. The primary endpoint is the composite endpoint of cardiovascular death, non-fatal major cardiovascular or peripheral arterial events. The secondary outcome measures will be individual components of the primary composite endpoint, all-cause death, and utility-based quality of life EQ5D-5L.
- Conditions
- Kidney Failure, Chronic, Hyperphosphatemia
- Being tested
- Liberal phosphate target, Intensive phosphate target
- Keywords
- Renal dialysis, Randomised controlled trial, Bone markers, Cardiovascular risk factors, Phosphate lowering agent, End stage kidney disease, Hyperphosphatemia
- Medical subject headings
- Kidney Failure, Chronic, Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liberal phosphate targetDrug
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 targetDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Liberal phosphate target | Active comparator | Liberal serum phosphate target of 2.0 to 2.5 mmol/L. Receives: Drug: Liberal phosphate target |
| Intensive phosphate target | Experimental | Intensive serum phosphate target of ≤1.50 mmol/L. Receives: Drug: Intensive phosphate target |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (3)
Time to individual components of the primary composite endpoint,
Measured: 5 years
Time to all-cause death
Measured: 5 years
Utility-based quality of life EQ5D-5L
EQ5D-5L will be used to assess patient self-reported quality of life measures.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start10 Dec 2019
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Applied Health Research Centre, Cambridge University Hospitals NHS Foundation Trust, University of Otago
- Responsible party
- Sponsor
- Investigators
- Sunil Badve, Principal investigator, University of New South WalesRon Wald, Principal investigator, Unity Health TorontoRona Smith, Principal investigator, University of CambridgeSuetonia Green, Principal investigator, University of OtagoPatrick Mark, Principal investigator, University of GlasgowRathika Krishnasamy, Principal investigator, The University of QueenslandMichael Walsh, Principal investigator, Hamilton Centre for Kidney Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573089
- Sponsor's protocol ID
- AKTN 17.02
- Acronym
- PHOSPHATE
- Status last verified
- Jun 2026
- First submitted
- 20 May 2018
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 40638247Natale 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.
PubMed 40576086Fajol A, Faul C. The Pathologic Actions of Phosphate in CKD. Kidney360. 2025 Apr 17;6(6):1040-1049. doi: 10.34067/KID.0000000820.
PubMed 40241437Fernandez 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.
PubMed 40238244Edmonston 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.
PubMed 39671553