Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE)
Actively Recruiting
About This Study
This pragmatic, international, randomized trial evaluates whether intensive serum phosphate lowering improves cardiovascular outcomes in 3,600 adult patients with ESKD receiving dialysis. Participants are randomized to either an intensive phosphate target (≤1.50 mmol/L) or a liberal target (2.0–2.5 mmol/L) using physician-discretionary phosphate binders. The primary endpoint is a composite of cardiovascular death and non-fatal major cardiovascular or peripheral arterial events. Secondary outcomes include all-cause mortality, health-related quality of life, and cost-effectiveness. The study aims to provide high-level evidence for current clinical guidelines that suggest targeting normal phosphate levels despite a lack of definitive prospective data.
Who Can Participate?
✓ Inclusion Criteria
- •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 Criteria
- •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.