Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE)
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
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
Treatments tested in this trial
- Liberal phosphate target
- Intensive phosphate target
Treatment groups
3,600 Participants
are divided into 2 treatment groupsLocations
115Australia
Royal Prince Alfred Hosptial2050, CamperdownNew South Wales, Australia
Nepean Hospital2750, KingswoodNew South Wales, Australia
St George Hospital2217, KogarahNew South Wales, Australia
Royal North Shore Hospital2065, Saint LeonardsNew South Wales, Australia
Sponsors and collaborators
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