International Trial Comparing Intensive Versus Standard Phosphate Level Targets in Adults with End-stage Kidney Disease on Dialysis to Improve Heart Outcomes and Quality of Life

What this Trial Is About

This research aims to evaluate the effects of lowering blood phosphate levels in adults with end-stage kidney disease ESKD who are receiving dialysis. Elevated phosphate levels are common in ESKD and linked to higher risk of death and heart problems, but it is unclear if reducing phosphate improves important patient outcomes. The study will compare intensive lowering of phosphate to a more liberal phosphate target to see if this reduces heart-related deaths and events, improves physical health, and is cost-effective. Participants will be randomly assigned to one of two groups one aiming for a liberal serum phosphate target of 2.0 to 2.5 mmolL, and the other aiming for an intensive target of 1.50 mmolL or lower. Doctors will decide the type and dose of phosphate-lowering medications to help participants reach their assigned phosphate levels, following usual local practices. The study will last up to five years and is conducted internationally with 3600 adults on dialysis. During the study, researchers will monitor participants for major heart-related events and deaths, physical health, fatigue, quality of life, patient satisfaction, and itching. Regular assessments will include measuring time to cardiovascular death or major cardiovascular events and evaluating overall survival and quality of life using the EQ5D-5L tool. The study will also assess cost-effectiveness and continue to observe participants for five years to collect comprehensive data on these outcomes.

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