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.
Status: Recruiting
Location: See all (126) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Australia
Central and Northern Adelaide Renal and Transplant Service
COMPLETED
Adelaide
Armadale Hospital
COMPLETED
Armadale
Flinders Medical Centre
COMPLETED
Bedford Park
Sunshine Coast University Hospital
COMPLETED
Birtinya
Princess Alexandra Hospital
COMPLETED
Brisbane
Royal Brisbane and Women's Hospital
COMPLETED
Brisbane
Bundaberg Hospital
COMPLETED
Bundaberg
Cairns Hospital
COMPLETED
Cairns
Royal Prince Alfred Hosptial
COMPLETED
Camperdown
Austin Health
COMPLETED
Heidelberg
Fraser Coast Renal Service
COMPLETED
Hervey Bay
Nepean Hospital
COMPLETED
Kingswood
St George Hospital
COMPLETED
Kogarah
Mackay Hospital
COMPLETED
Mackay
Logan Hospital
COMPLETED
Meadowbrook
Royal Melbourne Hospital
COMPLETED
Melbourne
St Vincent's Hospital Melbourne
COMPLETED
Melbourne
Royal North Shore Hospital
COMPLETED
Saint Leonards
Gold Coast University Hospital
COMPLETED
Southport
Townsville University Hospital
COMPLETED
Townsville
Latrobe Regional Hospital
COMPLETED
Traralgon
Western Sydney Renal Service
COMPLETED
Westmead
Wollongong Hospital
COMPLETED
Wollongong
Brazil
Fundacao Felice Rosso - Hospital Felicio Rocho
RECRUITING
Barro Preto
Sociedade Hospitalar Angelina Caron
RECRUITING
Campina Grande
BRA Santa Casa de Misericórdia de Ponta Grossa
RECRUITING
Ponta Grossa
Hospital de Clinicas Porto Alegre
RECRUITING
Porto Alegre
Hospital Alemao Oswaldo Cruz
RECRUITING
São Paulo
Serviço Ubaense de Nefrologia Ltda
RECRUITING
Ubá
Canada
Foothills Hospital/ U of Calgary
RECRUITING
Calgary
Alberta Health Services
RECRUITING
Edmonton
Dalhousie University
RECRUITING
Halifax
Queen's University
RECRUITING
Kingston
London Health Sciences Centre
RECRUITING
London
The Charles Lemoyne Hospital
RECRUITING
Longueuil
CHUM
RECRUITING
Montreal
Hopital Maisonneuve Rosemont
RECRUITING
Montreal
Jewish General Hospital
RECRUITING
Montreal
McGill University Health Centre
RECRUITING
Montreal
Sacre Coeur Hospital
RECRUITING
Montreal
Sunnybrook Health Sciences Centre
RECRUITING
North York
Oakville Trafalgar Memorial Hospital
RECRUITING
Oakville
Orillia Soldier's Memorial Hospital
RECRUITING
Orillia
Lakeridge Health
RECRUITING
Oshawa
The Ottawa Hospital
RECRUITING
Ottawa
CHU de Quebec Universite Laval
RECRUITING
Québec
Red Deer Hospital;
RECRUITING
Red Deer
Prairie Vascular Research Inc
RECRUITING
Regina
Mackenzie Health
RECRUITING
Richmond Hill
Scarborough Hospital Network
RECRUITING
Scarborough Village
Centre Hospitalier Universitaire de Sherbrooke
RECRUITING
Sherbrooke
Centre hospitalier universitaire de Sherbrooke (CHUS)
RECRUITING
Sherbrooke
Humber River Hospital
RECRUITING
Toronto
Michael Garron Hospital
RECRUITING
Toronto
St Michael's Hospital
RECRUITING
Toronto
St. Joseph's Healthcare Hamilton
RECRUITING
Toronto
St. Joseph's Healthcare Toronto
RECRUITING
Toronto
Trillium Health Partners
RECRUITING
Toronto
University Health Network - University of Toronto
RECRUITING
Toronto
St. Paul's Hospital
RECRUITING
Vancouver
Vancouver General Hospital
COMPLETED
Vancouver
St. Boniface General Hospital
RECRUITING
Winnipeg
France
AURA Paris Plaisance
RECRUITING
Paris
Israel
Hadassah University
RECRUITING
Jerusalem
Shaare Zedek Medical Centre
RECRUITING
Jerusalem
Meir Hospital
RECRUITING
Kfar Saba
Sheba Hospital
RECRUITING
Ramat Gan
Tel Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
New Zealand
Auckland City Hospital
COMPLETED
Auckland
Christchurch Hospital
COMPLETED
Christchurch
Dunedin Hospital
COMPLETED
Dunedin
Waikato DHB
COMPLETED
Hamilton
Hawkes Bay Hospital
COMPLETED
Hastings
Middlemore Hospital
COMPLETED
Otahuhu
Waitematā Hospital
COMPLETED
Takapuna
Northland DHB
COMPLETED
Whangarei
Singapore
Khoo Teck Puat Hospital
RECRUITING
Singapore
Tan Tock Seng Hospital Pte. Ltd.
RECRUITING
Singapore
Woodlands Health
RECRUITING
Singapore
Thailand
Ramathibodi Hospital
RECRUITING
Bangkok
United Kingdom
NHS Lanarkshire
RECRUITING
Airdrie
Wirral University Teaching Hospital NHS Foundation Trust
RECRUITING
Birkenhead
University Hospital Birmingham NHS foundation Trust
RECRUITING
Birmingham
Bradford Teaching Hospital NHS Foundation Trust
RECRUITING
Bradford
University Hospitals Sussex NHS Foundation Trust
RECRUITING
Brighton
West Suffolk Hospital
RECRUITING
Bury St Edmunds
Cambridge University Hospitals NHS Foundation Trust
RECRUITING
Cambridge
East Kent Hospitals University NHS Foundation Trust
RECRUITING
Canterbury
Cardiff and Wales University Local Health Board
RECRUITING
Cardiff
North Cumbria Integrated Care NHS Foundation Trust
RECRUITING
Carlisle
Epsom and St Helier University Hospitals NHS Trust
RECRUITING
Carshalton
Gloucestershire Hospital NHS Foundation Trust
RECRUITING
Cheltenham
Portsmouth Hospitals University NHS Trust
RECRUITING
Cosham
University Hospitals Coventry & Warwickshire
RECRUITING
Coventry
University Hospitals of Derby and Burton
RECRUITING
Derby
Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
RECRUITING
Doncaster
Dorset County Hospital NHS Foundation Trust
RECRUITING
Dorchester
The Dudley Group NHS Foundation Trust
RECRUITING
Dudley
Royal Devon and Exeter NHS Foundation Trust
RECRUITING
Exeter
NHS Greater Glasgow and Clyde
RECRUITING
Glasgow
James Paget University Hospitals NHS Foundation Trust
RECRUITING
Great Yarmouth
Hull University Teaching Hospital NHS Trust
RECRUITING
Hull
NHS Highland
RECRUITING
Inverness
Ipswich Hospital (East Suffolk & North Essex Foundation Trust)
RECRUITING
Ipswich
NHS Ayrshire and Arran
RECRUITING
Kilmarnock
University Hospitals Of Leicester NHS Trust
RECRUITING
Leicester
Royal Liverpool University Hospitals
RECRUITING
Liverpool
University Hospital Aintree
RECRUITING
Liverpool
Guy's and St Thomas' NHS Foundation Trust
RECRUITING
London
King's College Hospital NHS Foundation Trust
RECRUITING
London
St George's University Hospitals NHS Foundation Trust
RECRUITING
London
Manchester University NHS Foundation Trust
RECRUITING
Manchester
South Tees Hospitals NHS Foundation Trust
RECRUITING
Middlesbrough
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
RECRUITING
Newcastle Upon Tyne
Nottingham University Hospitals NHS Trust
RECRUITING
Nottingham
University Hospitals Plymouth NHS Trust
RECRUITING
Plymouth
Royal Berkshire NHS Foundation Trust
RECRUITING
Reading
Salford Royal NHS Foundation Trust
RECRUITING
Salford
Sheffield Teaching Hospitals NHS Foundation Trust
RECRUITING
Sheffield
Shrewsbury and Telford Hospital NHS Trust
RECRUITING
Shrewsbury
Mid and South Essex NHS Foundation Trust
RECRUITING
Southend-on-sea
East and North Hertfordshire NHS Trust
RECRUITING
Stevenage
University Hospital of North Midlands NHS Trust
RECRUITING
Stoke-on-trent
South Tyneside And Sunderland NHS Foundation Trust
RECRUITING
Sunderland
The Royal Wolverhampton NHS Trust
RECRUITING
Wolverhampton
York and Scarborough Teaching Hospitals NHS Foundation Trust
RECRUITING
York
Contact Information
Primary
Ron Wald
WaldR@smh.ca
416 867 3703
Backup
Rona Smith
rms50@cam.ac.uk
+44 07929642380
Time Frame
Start Date: 2019-12-10
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 3600
Treatments
Active_comparator: Liberal phosphate target
Liberal serum phosphate target of 2.0 to 2.5 mmol/L.
Experimental: Intensive phosphate target
Intensive serum phosphate target of ≤1.50 mmol/L.
Authors
Related Therapeutic Areas
Sponsors
Leads: The University of Queensland
Collaborators: Cambridge University Hospitals NHS Foundation Trust, Applied Health Research Centre, National Health and Medical Research Council, Australia, University of Otago