Comparing Liberal phosphate target with Intensive phosphate target for chronic kidney failure
Official title: Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE)
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.
- 2 groups
- Sites in Red Deer, Toronto and 18 more cities
- Recruiting
Interventions
- Medication
Liberal phosphate target
All phosphate-lowering medications in use at baseline will be discontinued. Phosphate-lowering medications will be prescribed only if serum phosphate concentration exceeds 2.50 mmol/L. The choice and dosages of phosphate-lowering medications will be at the discretion of treating physicians and/or participants.
- Medication
Intensive phosphate target
This will be achieved by prescribing phosphate-lowering medications aimed to intensively lower serum phosphate concentration towards normal level (≤1.50 mmol/L). The choice and dosages of phosphate-lowering medications will be at the discretion of treating physicians and/or participants.
Canadian Sites (33)
32 of 33 recruiting
- Recruiting
Foothills Hospital/ U of Calgary
Calgary, Alberta
- Recruiting
Alberta Health Services
Edmonton, Alberta
- Recruiting
St. Paul's Hospital
Vancouver, British Columbia
- Recruiting
St. Boniface General Hospital
Winnipeg, Manitoba
- Recruiting
Dalhousie University
Halifax, Nova Scotia
- Recruiting
Queen's University
Kingston, Ontario
- Recruiting
London Health Sciences Centre
London, Ontario
- Recruiting
Sunnybrook Health Sciences Centre
North York, Ontario
- Recruiting
Oakville Trafalgar Memorial Hospital
Oakville, Ontario
- Recruiting
Orillia Soldier's Memorial Hospital
Orillia, Ontario
- Recruiting
Lakeridge Health
Oshawa, Ontario
- Recruiting
The Ottawa Hospital
Ottawa, Ontario
- Recruiting
Mackenzie Health
Richmond Hill, Ontario
- Recruiting
Scarborough Hospital Network
Scarborough Village, Ontario
- Recruiting
St Michael's Hospital
Toronto, Ontario
- Recruiting
University Health Network - University of Toronto
Toronto, Ontario
- Recruiting
St. Joseph's Healthcare Hamilton
Toronto, Ontario
- Recruiting
St. Joseph's Healthcare Toronto
Toronto, Ontario
- Recruiting
The Charles Lemoyne Hospital
Longueuil, Quebec
- Recruiting
McGill University Health Centre
Montreal, Quebec
- Recruiting
Hopital Maisonneuve Rosemont
Montreal, Quebec
- Recruiting
CHUM
Montreal, Quebec
- Recruiting
Jewish General Hospital
Montreal, Quebec
- Recruiting
Sacre Coeur Hospital
Montreal, Quebec
- Recruiting
CHU de Quebec Universite Laval
Québec, Quebec
- Recruiting
Centre hospitalier universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec
- Recruiting
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec
- Recruiting
Red Deer Hospital;
Red Deer
- Recruiting
Prairie Vascular Research Inc
Regina, Saskatchewan
- Recruiting
Humber River Hospital
Toronto
- Recruiting
Michael Garron Hospital
Toronto
- Recruiting
Trillium Health Partners
Toronto
- Completed
Vancouver General Hospital
Vancouver, British Columbia
Eligibility Criteria
See who this study is looking for7 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
Exclusion
- −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 studyInterventional studyA study where participants are given something to see what happens.Read more → that is likely to affect serum phosphate concentration.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the comparison group, receives Liberal phosphate target.
Registry label: A: Liberal phosphate target
Group B receives Intensive phosphate target.
Registry label: B: Intensive phosphate target
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 3,600 people.
The study is currently expected to finish around December 2028.
The main measurement is taken over: 5 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Time to a composite endpointEndpointThe specific thing a study measures to answer its question.Read more → of cardiovascular death or non-fatal major cardiovascular event — measured over 5 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT03573089 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Liberal phosphate targetDrug
All phosphate-lowering medications in use at baseline will be discontinued. Phosphate-lowering medications will be prescribed only if serum phosphate concentration exceeds 2.50 mmol/L. The choice and dosages of phosphate-lowering medications will be at the discretion of treating physicians and/or participants.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Intensive phosphate targetDrug
This will be achieved by prescribing phosphate-lowering medications aimed to intensively lower serum phosphate concentration towards normal level (≤1.50 mmol/L). The choice and dosages of phosphate-lowering medications will be at the discretion of treating physicians and/or participants.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 5 years.
The study as a whole is currently expected to finish around 2028-12-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 3,600 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 22 locations, including: Red Deer, Canada; Toronto, Canada; Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; Winnipeg, Manitoba, Canada, and 16 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.