Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE)
- Conditions
- HyperphosphatemiaKidney Failure, Chronic
- Interventions
- Registration Number
- NCT03573089
- Lead Sponsor
- The University of Queensland
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3600
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intensive phosphate target Intensive phosphate target Intensive serum phosphate target of ≤1.50 mmol/L. Liberal phosphate target Liberal phosphate target Liberal serum phosphate target of 2.0 to 2.5 mmol/L.
- Primary Outcome Measures
Name Time Method Time to a composite endpoint of cardiovascular death or non-fatal major cardiovascular event 5 years Time to a composite endpoint of cardiovascular death, non-fatal myocardial infarction or coronary revascularization, stroke, or peripheral arterial event.
- Secondary Outcome Measures
Name Time Method Utility-based quality of life EQ5D-5L 5 years EQ5D-5L will be used to assess patient self-reported quality of life measures.
Time to individual components of the primary composite endpoint, 5 years Time to all-cause death 5 years
Related Research Topics
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Trial Locations
- Locations (99)
Royal Brisbane and Women's Hospital
🇦🇺Brisbane, Queensland, Australia
Townsville University Hospital
🇦🇺Townsville, Queensland, Australia
St Vincent's Hospital Melbourne
🇦🇺Melbourne, Victoria, Australia
Fundacao Felice Rosso - Hospital Felicio Rocho
🇧🇷Barro Preto, Brazil
Hospital Alemao Oswaldo Cruz
🇧🇷São Paulo, Brazil
Red Deer Hospital;
🇨🇦Red Deer, Canada
Humber River Hospital
🇨🇦Toronto, Canada
Michael Garron Hospital
🇨🇦Toronto, Canada
Trillium Health Partners
🇨🇦Toronto, Canada
Aura Paris
🇫🇷Paris, France
Hadassah University
🇮🇱Jerusalem, Israel
Shaare Zedek Medical Centre
🇮🇱Jerusalem, Israel
Meir Hospital
🇮🇱Kfar Saba, Israel
Sheba Hospital
🇮🇱Ramat Gan, Israel
Ramathibodi Hospital
🇹🇭Bangkok, Khet Ratchathewi, Thailand
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
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
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
Latrobe Regional Hospital
🇦🇺Traralgon, Victoria, Australia
Armadale Hospital
🇦🇺Armadale, Washington, Australia
Sociedade Hospitalar Angelina Caron
🇧🇷Campina Grande, Paraíba, Brazil
Hospital de Clinicas Porto Alegre
🇧🇷Porto Alegre, Rio Grande Do Sul, 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
Scarborough Hospital Network
🇨🇦Scarborough, 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
🇨🇦Montréal, Quebec, Canada
CHUM
🇨🇦Montréal, Quebec, Canada
Jewish General Hospital
🇨🇦Montréal, Quebec, Canada
Sacre Coeur Hospital
🇨🇦Montréal, Quebec, Canada
CHU de Quebec Universite Laval
🇨🇦Quebec City, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada
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
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
Gloucestershire Hospital NHS Foundation Trust
🇬🇧Cheltenham, United Kingdom
Royal Devon and Exeter NHS Foundation Trust
🇬🇧Exeter, United Kingdom
University Hospitals Of Leicester NHS Trust
🇬🇧Leicester, 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