Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE)
Recruiting · NCT03573089 · Interventional (participants receive a specific treatment) · Lead sponsor: The University of Queensland
View the official record on ClinicalTrials.gov →Interventions studied
Intensive phosphate targetLiberal phosphate target
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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.
Where it is running
60 locations listed.
- Auckland City Hospital - Auckland, New Zealand
- Fundacao Felice Rosso - Hospital Felicio Rocho - Barro Preto, Brazil
- 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
- Christchurch Hospital - Christchurch, New Zealand
- Portsmouth 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
- The Dudley Group NHS Foundation Trust - Dudley, United Kingdom
- Dunedin Hospital - Dunedin, New Zealand
- Royal Devon and Exeter NHS Foundation Trust - Exeter, United Kingdom
- Waikato DHB - Hamilton, New Zealand
- Hawkes Bay Hospital - Hastings, New Zealand
- Hull University Teaching Hospital NHS Trust - Hull, United Kingdom
- Ipswich Hospital (East Suffolk & North Essex Foundation Trust) - Ipswich, United Kingdom
- Hadassah University - Jerusalem, Israel
- Shaare Zedek Medical Centre - Jerusalem, Israel
- Meir Hospital - Kfar Saba, Israel
- 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
- Middlemore Hospital - Otahuhu, New Zealand
- AURA Paris Plaisance - Paris, France
- Sheba Hospital - Ramat Gan, Israel
- Royal Berkshire NHS Foundation Trust - Reading, United Kingdom
- Red Deer Hospital; - Red Deer, Canada
- Salford Royal NHS Foundation Trust - Salford, United Kingdom
- Khoo Teck Puat Hospital - Singapore, Singapore
- Tan Tock Seng Hospital Pte. Ltd. - Singapore, Singapore
- Woodlands Health - Singapore, Singapore
- Mid and South Essex NHS Foundation Trust - Southend-on-Sea, United Kingdom
- Hospital Alemao Oswaldo Cruz - São Paulo, Brazil
- Waitematā Hospital - Takapuna, New Zealand
- Tel Aviv Sourasky Medical Center - Tel Aviv, Israel
- Humber River Hospital - Toronto, Canada
- Michael Garron Hospital - Toronto, Canada
- Trillium Health Partners - Toronto, Canada
- Northland DHB - Whangarei, New Zealand
- The Royal Wolverhampton NHS Trust - Wolverhampton, United Kingdom
- 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
- 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
- Ramathibodi Hospital - Bangkok, Khet Ratchathewi, Thailand
Showing 60 of 126 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →