Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE)
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- NA
Study ID
NCT03573089
Intervention or treatment
DRUG: Liberal phosphate target
DRUG: Intensive phosphate target
Conditions
- Kidney Failure, Chronic
- Hyperphosphatemia
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Research sites nearby
Closest Location:
Royal Prince Alfred Hosptial
Select from list below to view details:
Royal Prince Alfred Hosptial
Camperdown, New South Wales, Australia
Nepean Hospital
Kingswood, New South Wales, Australia
St George Hospital
Kogarah, New South Wales, Australia
Royal North Shore Hospital
Saint Leonards, New South Wales, Australia
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Who is running the clinical trial?
The University of Queensland
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ACTIVE_COMPARATOR: Liberal phosphate target
| Drug: Liberal phosphate target |
EXPERIMENTAL: Intensive phosphate target
| Drug: Intensive phosphate target |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Time to individual components of the primary composite endpoint, | Not Specified | 5 years |
| Time to all-cause death | Not Specified | 5 years |
| Utility-based quality of life EQ5D-5L | EQ5D-5L will be used to assess patient self-reported quality of life measures. | 5 years |
References
Clinical Trials Gov: Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE)Other trials to consider
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