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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    3600
  • sponsor
    The University of Queensland
Updated on 23 September 2021
diabetes
heart disease
renal failure
nephropathy
dialysis
renal disease
blood phosphate

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.

Description

Hyperphosphataemia is highly prevalent in patients with end-stage kidney disease (ESKD) and associated with increased mortality risk. The Clinical Practice Guidelines suggest lowering elevated phosphate levels towards the normal range (level 2C suggestion). However, trial data demonstrating that treatments that lower serum phosphate will improve patient-centred outcomes are lacking.

The primary objective is to test the hypothesis that compared to a liberal serum phosphate concentration target of 2.0 to 2.5 mmol/L, intensive lowering of serum phosphate towards the normal level (1.50 mmol/L) with phosphate binders reduces the risk of fatal or non-fatal major cardiovascular events in ESKD patients receiving dialysis. The secondary objectives are to test the hypothesis that intensive lowering of serum phosphate towards the normal level with phosphate binders would improve physical health, fatigue, health-related quality of life, patient satisfaction, and pruritus; and be cost-effective.

In this pragmatic, multinational, randomised controlled large simple trial, a total of 3600 adult ESKD patients receiving dialysis will be randomised either to intensive (1.50 mmol/L) or liberalized (2.0-2.5 mmol/L) serum phosphate target. The choice and dose of phosphate binders will be at the treating physician's discretion and local practice to achieve and maintain serum phosphate concentration within the required target range according to randomisation. The primary endpoint is the composite endpoint of cardiovascular death, non-fatal major cardiovascular or peripheral arterial events. The secondary outcome measures will be individual components of the primary composite endpoint, all-cause death, and utility-based quality of life EQ5D-5L.

Details
Condition Chronic renal failure, Hyperphosphatemia, end stage renal disease, chronic renal disease, end-stage renal disease, esrd, end-stage renal failure, end stage kidney disease, end stage renal failure
Treatment Liberal phosphate target, Intensive phosphate target
Clinical Study IdentifierNCT03573089
SponsorThe University of Queensland
Last Modified on23 September 2021

Eligibility

Yes No Not Sure

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
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