Health TrialsbyHealthPanel

Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE)

ConditionsKidney Failure, ChronicHyperphosphatemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Queensland

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 study that is likely to affect serum phosphate concentration.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Liberal phosphate target

    Drug

    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

    Drug

    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.

Treatment groups

3,600 Participants
are divided into 2 treatment groups
Group A: Liberal phosphate targetActive comparator 1 intervention
Group B: Intensive phosphate targetExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
5 years

Secondary outcomes

1

Time to individual components of the primary composite endpoint,

Time frame
5 years
2

Time to all-cause death

Time frame
5 years
3

Utility-based quality of life EQ5D-5L

EQ5D-5L will be used to assess patient self-reported quality of life measures.

Time frame
5 years

Other outcomes

1

Differences in the serum concentrations of phosphate, PTH, calcium, alkaline phosphatase and albumin

Time frame
Time Frame: 5 years
2

Phosphate-lowering medication usage

Time frame
5 years
3

Phosphate-lowering medication self-reported adherence

Time frame
5 years
4

Proportion of patients requiring parathyroidectomy

Time frame
5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Queensland

Lead sponsor

National Health and Medical Research Council, Australia

Collaborator

Applied Health Research Centre

Collaborator

Cambridge University Hospitals NHS Foundation Trust

Collaborator

University of Otago

Collaborator

Source ClinicalTrials.gov
Apply now