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.
The University of Queensland
3,600 participants
Dec 10, 2019
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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
Exclusion Criteria3
- 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.
Interventions
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.
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.
Locations(115)
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NCT03573089