At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Liberal phosphate target (drug), Intensive phosphate target (drug)
- How long the study runs
- Study runs about 108 months (dates as stated)
- About the drug or intervention
- Liberal phosphate target — drug: All phosphate-lowering medications in use at baseline will be discontinued. · Intensive phosphate target — drug: This will be achieved by prescribing phosphate-lowering medications aimed to intensively lower serum phosphate concentration towards normal level (≤1.50 mmol/L).
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, called PHOSPHATE, is looking at people with long-term (chronic) kidney failure whose blood contains too much phosphate (a mineral). It is comparing a higher phosphate target with a standard phosphate target to see which works better. The study is funded by The University of Queensland.
Who can take part
- Aged 45 or over, or aged 18 or over if you have diabetes
- Have kidney failure and have been on haemodialysis (a blood-filtering treatment) or peritoneal dialysis (a dialysis treatment through the tummy) for at least 3 months
- Currently take at least one medicine that lowers phosphate, at any dose
- Able to give informed consent to take part
Who may not be able to
- You have a kidney transplant already planned
- Your doctor believes you have another serious illness that may cause death within the next 6 months
- You are taking part in another study that could affect your blood phosphate level
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team about how many visits are needed, how long the study lasts, and what taking part would involve.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 3,600
- Started
- 2019-12-10
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for kidney failure, chronic
- • NA - 3,600 participants
- • During end-stage kidney disease, clinical guidelines suggest reducing elevated phosphate levels in the blood
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with kidney failure, chronic
Where?
- • Cambridge - Cambridge University Hospitals NHS Foundation Trust
- • Plymouth - University Hospitals Plymouth NHS Trust
- • Dorchester - Dorset County Hospital NHS Foundation Trust
- • Sunderland - South Tyneside And Sunderland NHS Foundation Trust
- • +42 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓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 agreement to take part
Who cannot take part
- ✗Elective kidney transplantation scheduled,
- ✗Concomitant major illness / other health condition that may result in death in the next 6 months in the view of the treating...
- ✗Participation in an interventional study that is likely to affect serum phosphate concentration.
See the full criteria
Where Is This Study? (46 UK sites)
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, United Kingdom
Dorset County Hospital NHS Foundation Trust
Dorchester, United Kingdom
Anthony Homer. Research Governance Manager
Research@dchft.nhs.uk01305 253 127South Tyneside And Sunderland NHS Foundation Trust
Sunderland, United Kingdom
Research and Development stsft.research@nhs.net
stsft.research@nhs.net0191 565 6256 ext 42143East and North Hertfordshire NHS Trust
Stevenage, United Kingdom
Rishma Bhatti, Head of Research (Mount Vernon Cancer Centre)
mvccresearch.enh-tr@nhs.net0203 826 2068 / 2069East Kent Hospitals University NHS Foundation Trust
Canterbury, United Kingdom
Caroline Cowley, Research & Innovation/Clinical Trials Unit Manager
ekhuft.researchandinnovation@nhs.net01227 783169NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, United Kingdom
NHS Lanarkshire
Airdrie, United Kingdom
South Tees Hospitals NHS Foundation Trust
Middlesbrough, United Kingdom
York and Scarborough Teaching Hospitals NHS Foundation Trust
York, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
NHS Highland
Inverness, United Kingdom
NHS Ayrshire and Arran
Kilmarnock, United Kingdom
Shrewsbury and Telford Hospital NHS Trust
Shrewsbury, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom
University Hospital of North Midlands NHS Trust
Stoke-on-Trent, United Kingdom
West Suffolk Hospital
Bury St Edmunds, United Kingdom
University Hospitals Sussex NHS Foundation Trust
Brighton, United Kingdom
Bradford Teaching Hospital NHS Foundation Trust
Bradford, United Kingdom
Wirral University Teaching Hospital NHS Foundation Trust
Birkenhead, 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
Research and Development Team research@ncic.nhs.uk
nencadmin@nihr.ac.uk01228 523444Epsom and St Helier University Hospitals NHS Trust
Carshalton, United Kingdom
Gloucestershire Hospital NHS Foundation Trust
Cheltenham, United Kingdom
R&I Professional Services
ghn-tr.glos.riprofessionalservices@nhs.net033 422 5467Portsmouth Hospitals University NHS Trust
Cosham, 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
Dr Jane Fearnside - Head of Research
dbth.clinicalresearch@nhs.net01302 644069The 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
James Illingworth
hyp-tr.development.research@nhs.net01482 461883 or 461903Ipswich Hospital (East Suffolk & North Essex Foundation Trust)
Ipswich, United Kingdom
University Hospitals Of Leicester NHS Trust
Leicester, United Kingdom
Carolyn Maloney
uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351Royal 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
Leslie Frederick-Mokogwu
researchanddevelopment@royalberkshire.nhs.uk0118 322 7449Salford Royal NHS Foundation Trust
Salford, United Kingdom
Mid and South Essex NHS Foundation Trust
Southend-on-Sea, United Kingdom
The Royal Wolverhampton NHS Trust
Wolverhampton, United Kingdom
How to Get in Touch
Ron Wald
Sponsor contactCONTACT
Rona Smith
Sponsor contactCONTACT