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

Conditions

• Kidney Failure, Chronic
• Hyperphosphatemia

Interventions

DRUG

Liberal phosphate target

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.

DRUG

Intensive phosphate target

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.

Sponsors & Collaborators

• National Health and Medical Research Council, Australia

  collaborator OTHER

• Applied Health Research Centre

  collaborator OTHER

• Cambridge University Hospitals NHS Foundation Trust

  collaborator OTHER

• University of Otago

  collaborator OTHER

• The University of Queensland

  lead OTHER

Principal Investigators

• Sunil Badve · The University of Queensland

• Ron Wald · St Michael's Hospital

• Rona Smith · University of Cambridge

• Suetonia Green · University of Otago

• Patrick Mark · University of Glasgow

• Rathika Krishnasamy · The University of Queensland

• Michael Walsh · Hamilton Centre for Kidney Research

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-12-10

Primary Completion

2027-12-31

Completion

2028-12-31

Countries

• Australia
• Brazil
• Canada
• France
• Israel
• New Zealand
• Thailand
• United Kingdom

Study Locations