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Recruiting NCT03573089

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

Trial Parameters

Condition Kidney Failure, Chronic
Sponsor The University of Queensland
Study Type INTERVENTIONAL
Phase N/A
Enrollment 3,600
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2019-12-10
Completion 2027-12-31
Interventions
Liberal phosphate targetIntensive phosphate target

Brief 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 Criteria

Inclusion Criteria: 1. Age ≥45 years, or Age ≥18 years with diabetes, 2. ESKD on haemodialysis or peritoneal dialysis, for at least 3 months, 3. Currently prescribed at least one phosphate-lowering medication at any dose 4. Able to provide informed consent Exclusion Criteria: 1. Elective kidney transplantation scheduled, 2. Concomitant major illness / comorbidity that may result in death in the next 6 months in the view of the treating physician, 3. Participation in an interventional study that is likely to affect serum phosphate concentration.

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