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Evaluating phosphate level targets in patients with end-stage kidney disease

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.

Not applicable Interventional The University of Queensland · NCT03573089

This study tests if lowering blood phosphate levels more strictly helps adults with end-stage kidney disease feel better and reduces their risk of heart problems.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment3600 (estimated)
Ages18 Years and up
SexAll
SponsorThe University of Queensland Academic / other
Locations115 sites (Camperdown, New South Wales and 114 other locations)
Trial IDNCT03573089 on ClinicalTrials.gov

What this trial studies

This trial investigates the impact of lowering blood phosphate levels in patients with end-stage kidney disease (ESKD) on critical health outcomes. It compares a liberal phosphate target of 2.0 to 2.5 mmol/L with an intensive target of ≤1.50 mmol/L to determine which approach better reduces the risk of cardiovascular events and improves overall patient health. The study involves 3600 adult patients receiving dialysis and utilizes phosphate binders as part of the treatment regimen. The primary focus is on patient-centered outcomes, including mortality and quality of life.

Who should consider this trial

Good fit: Ideal candidates are adults aged 45 and older, or those aged 18 and older with diabetes, who have been on dialysis for at least three months and are currently prescribed phosphate-lowering medications.

Not a fit: Patients scheduled for elective kidney transplantation or those with major comorbidities that may lead to death within six months may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved survival rates and quality of life for patients with end-stage kidney disease.

How similar studies have performed: While there is a lack of direct trial data on this specific approach, the study builds on existing guidelines and preliminary evidence suggesting that managing phosphate levels is crucial for ESKD patients.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Camperdown, New South Wales and 114 other locations

+65 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Kidney Failure, ChronicHyperphosphatemiaRenal dialysisRandomised controlled trialBone markersCardiovascular risk factorsPhosphate lowering agentEnd stage kidney disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.