Phosphate Level Management for Kidney Failure
(PHOSPHATE Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you must be on at least one phosphate-lowering medication to participate.
What data supports the effectiveness of phosphate-lowering medications for managing phosphate levels in kidney failure?
Are phosphate binders safe for managing phosphate levels in kidney failure?
Phosphate binders are generally considered safe for managing phosphate levels in kidney failure, but they can have side effects, especially affecting the stomach and intestines. Some types, like calcium-based binders, may lead to high calcium levels and other complications, while others like sevelamer and lanthanum carbonate have fewer side effects but can be expensive.16789
How does the Intensive and Liberal phosphate target treatment for kidney failure differ from other treatments?
This treatment is unique because it involves setting specific phosphate level targets (intensive or liberal) to manage kidney failure, using phosphate binders that do not contain calcium, which reduces the risk of vascular calcification and mortality compared to traditional calcium-based binders.125710
What is the purpose of this trial?
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.
Research Team
Ron Wald
Principal Investigator
St Michael's Hospital
Suetonia Green
Principal Investigator
University of Otago
Patrick Mark
Principal Investigator
University of Glasgow
Rathika Krishnasamy
Principal Investigator
The University of Queensland
Michael Walsh
Principal Investigator
Hamilton Centre for Kidney Research
Rona Smith
Principal Investigator
University of Cambridge
Sunil Badve
Principal Investigator
The University of Queensland
Eligibility Criteria
This trial is for adults with end-stage kidney disease (ESKD) who have been on dialysis for at least 3 months and are taking medication to lower phosphate levels. It's open to those over 45, or over 18 with diabetes, who can consent. People expecting a kidney transplant soon, in other trials affecting phosphate levels, or with illnesses likely causing death within six months cannot join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to either intensive or liberal serum phosphate targets and receive phosphate binders as per the assigned target
Follow-up
Participants are monitored for safety and effectiveness after treatment, focusing on cardiovascular events and quality of life
Treatment Details
Interventions
- Intensive phosphate target
- Liberal phosphate target
Intensive phosphate target is already approved in European Union, United States, Canada for the following indications:
- Chronic kidney disease
- End-stage kidney disease
- Hyperphosphatemia
- Chronic kidney disease
- End-stage kidney disease
- Hyperphosphatemia
- Chronic kidney disease
- End-stage kidney disease
- Hyperphosphatemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Queensland
Lead Sponsor
National Health and Medical Research Council, Australia
Collaborator
Applied Health Research Centre
Collaborator
Cambridge University Hospitals NHS Foundation Trust
Collaborator
University of Otago
Collaborator