Recruiting

Phosphate Targets

Sponsor:

The University of Queensland

Code:

NCT03573089

Conditions

Kidney Failure, Chronic

Hyperphosphatemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Liberal phosphate target

Intensive phosphate target

Study Details

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.

Conditions

Kidney Failure, Chronic

Hyperphosphatemia

Study ID

NCT03573089

Start date

Dec 10, 2019

Status verified date

Jun, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥45 years, or Age ≥18 years with diabetes,
2. ESKD on haemodialysis or peritoneal dialysis, for at least 3 months,
3. Currently prescribed at least one phosphate-lowering medication at any dose
4. Able to provide informed consent

Exclusion Criteria:

1. Elective kidney transplantation scheduled,
2. Concomitant major illness / comorbidity that may result in death in the next 6 months in the view of the treating physician,
3. Participation in an interventional study that is likely to affect serum phosphate concentration.

Study Design

Enrollment

3600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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.

Primary outcome measure

  • Time to a composite endpoint of cardiovascular death or non-fatal major cardiovascular event [ Time Frame: 5 years ]

Central Contacts and Locations

Locations

Foothills Hospital/ U of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 4Z6

Contacts

Alberta Health Services

Recruiting

Edmonton, Alberta, Canada

St. Paul's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

St. Boniface General Hospital

Recruiting

Winnipeg, Manitoba, Canada

Contacts

Alex Meraz-Munoz, Dr

amerazmunoz@sbgh.mb.ca

Dalhousie University

Recruiting

Halifax, Nova Scotia, Canada, B3H 4R2

Contacts

Queen's University

Recruiting

Kingston, Ontario, Canada, K7L 3N6

Contacts

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Sunnybrook Health Sciences Centre

Recruiting

North York, Ontario, Canada, M4N 3M5

Contacts

Oakville Trafalgar Memorial Hospital

Recruiting

Oakville, Ontario, Canada, L6M 0L8

Contacts

Orillia Soldier's Memorial Hospital

Recruiting

Orillia, Ontario, Canada

Lakeridge Health

Recruiting

Oshawa, Ontario, Canada, L1G 2B9

Contacts

Andrew Steele

asteele@lh.ca

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Swapnil Hiremath

shiremath@toh.ca

Mackenzie Health

Recruiting

Richmond Hill, Ontario, Canada

Scarborough Hospital Network

Recruiting

Scarborough Village, Ontario, Canada, M1P 2V5

Contacts

St Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

University Health Network - University of Toronto

Recruiting

Toronto, Ontario, Canada, M5G 1L7

Contacts

St. Joseph's Healthcare Hamilton

Recruiting

Toronto, Ontario, Canada, M6R 1B5

Contacts

St. Joseph's Healthcare Toronto

Recruiting

Toronto, Ontario, Canada, M6R 1B5

Contacts

The Charles Lemoyne Hospital

Recruiting

Longueuil, Quebec, Canada

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, 4A 3J1

Contacts

Hopital Maisonneuve Rosemont

Recruiting

Montreal, Quebec, Canada, H1T 2M4

Contacts

Annie-Claire Nadeau-Fredette

acnadeau-fredette.hmr@ssss.gouv.qc.ca

CHUM

Recruiting

Montreal, Quebec, Canada, H2W 1T8

Contacts

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Sacre Coeur Hospital

Recruiting

Montreal, Quebec, Canada, H4J 1C5

Contacts

CHU de Quebec Universite Laval

Recruiting

Québec, Quebec, Canada, G1V 4G2

Contacts

Centre hospitalier universitaire de Sherbrooke (CHUS)

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Centre Hospitalier Universitaire de Sherbrooke

Recruiting

Sherbrooke, Quebec, Canada

Prairie Vascular Research Inc

Recruiting

Regina, Saskatchewan, Canada, S4P 0W5

Contacts

Red Deer Hospital;

Recruiting

Red Deer, Canada

Humber River Hospital

Recruiting

Toronto, Canada

Michael Garron Hospital

Recruiting

Toronto, Canada

Trillium Health Partners

Recruiting

Toronto, Canada

More Information

Sponsor

The University of Queensland

Last update posted

Aug 26, 2026

Last verified

Jun, 2026

Keywords

  • Renal dialysis
  • Randomised controlled trial
  • Bone markers
  • Cardiovascular risk factors
  • Phosphate lowering agent
  • End stage kidney disease
  • Hyperphosphatemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Queensland on 2026-08-26.