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Clinical Trial Details

Trial ID: L0668
Source ID: NCT03573089
Associated Drug: Liberal Phosphate Target
Title: Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE)
Acronym: PHOSPHATE
Status: RECRUITING
Study Results: NO
Results:
Conditions: Kidney Failure, Chronic|Hyperphosphatemia
Interventions: DRUG: Liberal phosphate target|DRUG: Intensive phosphate target
Outcome Measures: Primary: 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., 5 years | Secondary: Time to individual components of the primary composite endpoint,, 5 years|Time to all-cause death, 5 years|Utility-based quality of life EQ5D-5L, EQ5D-5L will be used to assess patient self-reported quality of life measures., 5 years | Other: Differences in the serum concentrations of phosphate, PTH, calcium, alkaline phosphatase and albumin, Time Frame: 5 years|Phosphate-lowering medication usage, 5 years|Phosphate-lowering medication self-reported adherence, 5 years|Proportion of patients requiring parathyroidectomy, 5 years|Proportion of patients developing calciphylaxis, 5 years|Gastrointestinal Symptom Rating Scale, The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item instrument designed to assess the symptoms associated with common GI disorders. It has five subscales (reflux, diarrhea, constipation, abdominal pain and indigestion). Subscale scores range from 1-7 and higher scores represent higher symptom burden i.e. more discomfort., 5 years|Itch/pruritus visual analog scale, The Pruritis 5-D scale contains five domains: duration, degree, direction, disability and distribution. The scores of each of the five domains are achieved separately and then summed together to obtain a total 5-D score. 5-D scores can potentially range between 5 (no pruritus) and 25 (most severe pruritus)., 5 years|Cost-effectiveness analysis:, Difference in the incremental cost per Quality Adjusted Life Years gained, 5 years
Sponsor/Collaborators: Sponsor: The University of Queensland | Collaborators: National Health and Medical Research Council, Australia|Applied Health Research Centre|Cambridge University Hospitals NHS Foundation Trust|University of Otago
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 3600
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-12-10
Completion Date: 2028-12-31
Results First Posted:
Last Update Posted: 2024-10-16
Locations: Royal Prince Alfred Hosptial, Camperdown, New South Wales, 2050, Australia|Nepean Hospital, Kingswood, New South Wales, 2750, Australia|St George Hospital, Kogarah, New South Wales, 2217, Australia|Royal North Shore Hospital, Saint Leonards, New South Wales, 2065, Australia|Western Sydney Renal Service, Westmead, New South Wales, 2145, Australia|Wollongong Hospital, Wollongong, New South Wales, 2500, Australia|Sunshine Coast University Hospital, Birtinya, Queensland, 4575, Australia|Royal Brisbane and Women's Hospital, Brisbane, Queensland, 4006, Australia|Princess Alexandra Hospital, Brisbane, Queensland, 4110, Australia|Bundaberg Hospital, Bundaberg, Queensland, 4670, Australia|Cairns Hospital, Cairns, Queensland, 4870, Australia|Fraser Coast Renal Service, Hervey Bay, Queensland, 4655, Australia|Mackay Hospital, Mackay, Queensland, 4740, Australia|Logan Hospital, Meadowbrook, Queensland, 4131, Australia|Gold Coast University Hospital, Southport, Queensland, 4215, Australia|Townsville University Hospital, Townsville, Queensland, 4817, Australia|Central and Northern Adelaide Renal and Transplant Service, Adelaide, South Australia, 5000, Australia|Flinders Medical Centre, Bedford Park, South Australia, 5042, Australia|Austin Health, Heidelberg, Victoria, 3084, Australia|Royal Melbourne Hospital, Melbourne, Victoria, 3050, Australia|St Vincent's Hospital Melbourne, Melbourne, Victoria, 3065, Australia|Latrobe Regional Hospital, Traralgon, Victoria, 3844, Australia|Armadale Hospital, Armadale, Washington, 6112, Australia|Sociedade Hospitalar Angelina Caron, Campina Grande, Paraíba, 58407-350, Brazil|Hospital de Clinicas Porto Alegre, Porto Alegre, Rio Grande Do Sul, Brazil|Fundacao Felice Rosso - Hospital Felicio Rocho, Barro Preto, Brazil|Hospital Alemao Oswaldo Cruz, São Paulo, Brazil|Foothills Hospital/ U of Calgary, Calgary, Alberta, T2N 4Z6, Canada|Alberta Health Services, Edmonton, Alberta, Canada|St. Paul's Hospital, Vancouver, British Columbia, V6Z 1Y6, Canada|Vancouver General Hospital, Vancouver, British Columbia, Canada|Dalhousie University, Halifax, Nova Scotia, B3H 4R2, Canada|Queen's University, Kingston, Ontario, K7L 3N6, Canada|London Health Sciences Centre, London, Ontario, N6A 5W9, Canada|Oakville Trafalgar Memorial Hospital, Oakville, Ontario, L6M 0L8, Canada|Orillia Soldier's Memorial Hospital, Orillia, Ontario, Canada|Lakeridge Health, Oshawa, Ontario, L1G 2B9, Canada|The Ottawa Hospital, Ottawa, Ontario, K1H 8L6, Canada|Scarborough Hospital Network, Scarborough, Ontario, M1P 2V5, Canada|St Michael's Hospital, Toronto, Ontario, M5B 1W8, Canada|University Health Network - University of Toronto, Toronto, Ontario, M5G 1L7, Canada|St. Joseph's Healthcare Hamilton, Toronto, Ontario, M6R 1B5, Canada|St. Joseph's Healthcare Toronto, Toronto, Ontario, M6R 1B5, Canada|The Charles Lemoyne Hospital, Longueuil, Quebec, Canada|McGill University Health Centre, Montreal, Quebec, 4A 3J1, Canada|Hopital Maisonneuve Rosemont, Montréal, Quebec, H1T 2M4, Canada|CHUM, Montréal, Quebec, H2W 1T8, Canada|Jewish General Hospital, Montréal, Quebec, H3T 1E2, Canada|Sacre Coeur Hospital, Montréal, Quebec, H4J 1C5, Canada|CHU de Quebec Universite Laval, Quebec City, Quebec, G1V 4G2, Canada|Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada|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|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|Ramathibodi Hospital, Bangkok, Khet Ratchathewi, 10400, Thailand|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
URL: https://clinicaltrials.gov/show/NCT03573089

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress