An interventional study of Liberal phosphate target and Intensive phosphate target in Kidney Failure, Chronic and Hyperphosphatemia, sponsored by The University of Queensland. Recruiting at 126 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by The University of Queensland · Not applicable, Interventional, and Treatment
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.
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.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's planned enrollment of 3,600 is above the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →The University of Queensland is the lead sponsor of 91 studies on the registry; 24 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Liberal serum phosphate target of 2.0 to 2.5 mmol/L.
Drug: Liberal phosphate target
Intensive serum phosphate target of ≤1.50 mmol/L.
Drug: Intensive 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.
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.
Time to a composite endpoint of cardiovascular death or non-fatal major cardiovascular event
Time to a composite endpoint of cardiovascular death, non-fatal myocardial infarction or coronary revascularization, stroke, or peripheral arterial event.
Time frame: 5 years
Time to individual components of the primary composite endpoint,
Time frame: 5 years
Time to all-cause death
Time frame: 5 years
Utility-based quality of life EQ5D-5L
EQ5D-5L will be used to assess patient self-reported quality of life measures.
Time frame: 5 years
Differences in the serum concentrations of phosphate, PTH, calcium, alkaline phosphatase and albumin
Time frame: Time Frame: 5 years
Phosphate-lowering medication usage
Time frame: 5 years
Phosphate-lowering medication self-reported adherence
Time frame: 5 years
Proportion of patients requiring parathyroidectomy
Time frame: 5 years
Proportion of patients developing calciphylaxis
Time frame: 5 years
Gastrointestinal Symptom Rating Scale
The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item instrument designed to assess the symptoms associated with common GI disorders. It has five subscales (reflux, diarrhea, constipation, abdominal pain and indigestion). Subscale scores range from 1-7 and higher scores represent higher symptom burden i.e. more discomfort.
Time frame: 5 years
Itch/pruritus visual analog scale
The Pruritis 5-D scale contains five domains: duration, degree, direction, disability and distribution. The scores of each of the five domains are achieved separately and then summed together to obtain a total 5-D score. 5-D scores can potentially range between 5 (no pruritus) and 25 (most severe pruritus).
Time frame: 5 years
Cost-effectiveness analysis:
Difference in the incremental cost per Quality Adjusted Life Years gained
Time frame: 5 years
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Showing the first 100 of 126 sites across 9 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Individual participant data that underlie the results reported in the primary publication, after deidentification (text, tables, figures and appendices) will be available for individual participant data meta-analysis.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 2 years and ending 5 years following main publication. Proposals may be submitted up to 5 years following article publication. After 5 years, the data will be available in our University's data warehouse but without investigator support other than deposited metadata.
Access criteria: An independent review board will assess proposals based on the following criteria: sound science, benefit-risk balancing and research team expertise.
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