Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE)
If you have serious kidney failure, your blood phosphate levels can get too high. Doctors usually recommend bringing these levels down, but we don't fully understand if this truly improves how people feel and live. This study, called PHOSPHATE, aims to find out. We want to see if intensely lowering phosphate levels, compared to a less strict approach, can reduce serious heart events like heart attacks, improve your physical health, and even save costs. Thousands of adults with kidney failure on dialysis across different countries will take part. We'll divide them into two groups: one aiming for very low phosphate, and another for slightly higher levels. The study will help doctors know the best way to manage phosphate for people with kidney disease.
At a glance
What is this study about?
When your kidneys aren't working properly, they can struggle to remove a substance called phosphate from your blood. This can lead to phosphate levels becoming too high, a condition called hyperphosphatemia. Current guidelines suggest trying to lower these high phosphate levels, but surprisingly, there isn't much clear evidence from big studies to show that doing so actually makes a big difference to how patients feel or live.
That's where the PHOSPHATE study comes in. We want to investigate whether lowering phosphate levels more aggressively really helps people with kidney failure. We're comparing two ways of managing phosphate: one where doctors aim for much lower levels (this is called the 'intensive' target) and another where they aim for slightly higher, but still managed, levels (the 'liberal' target). We want to see if the more intensive approach leads to fewer serious heart problems, better physical health, and is a good use of healthcare resources.
This is a very important study because over 3,000 adults with end-stage kidney disease (meaning their kidneys have largely stopped working) who are on dialysis will take part. Their doctors will decide which phosphate-lowering medicines to use and adjust the doses to meet the target for their assigned group. By comparing these two groups, we hope to gain a much clearer understanding of the best way to manage phosphate to improve the long-term health and well-being of people living with severe kidney disease.
Key takeaways
- The study investigates the best way to manage high phosphate in kidney failure.
- It compares aiming for very low vs. slightly higher phosphate levels.
- Goal is to see if lower phosphate reduces heart problems and improves health.
- Over 3,000 adults on dialysis will participate across various countries.
- Participation helps future treatment guidelines for kidney disease patients.
- You can withdraw at any time without affecting your regular care.
Who may be eligible?
To be able to join this study, you generally need to be an adult of at least 45 years old, or at least 18 years old if you also have diabetes. You must also have end-stage kidney disease and have been receiving either haemodialysis or peritoneal dialysis for at least three months.
Another key requirement is that you are currently taking at least one medicine to help lower your phosphate levels, no matter the dose. You also need to be able to understand what the study involves and agree to take part by giving your informed consent.
You wouldn't be able to join if you have an operation for a kidney transplant planned in the near future, or if your doctor thinks you have another serious illness that might lead to you passing away within the next six months. Also, if you're already in another study that could affect your phosphate levels, you wouldn't be eligible for this one.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 45 or older, or 18+ with diabetes?
- Do you have advanced kidney failure and get dialysis (haemodialysis or peritoneal dialysis) and have been for at least 3 months?
- Are you currently taking any medicine to lower your phosphate levels?
- Are you able to understand the study and agree to take part?
- Have you *not* got a kidney transplant planned soon?
- Does your doctor think you are likely to be well for at least the next 6 months (i.e. no other serious, rapidly progressing illness)?
What does participation involve?
If you decide to take part in the PHOSPHATE study, you would be randomly assigned to one of two groups. One group will aim for lower blood phosphate levels, and the other will aim for slightly higher levels. Your healthcare team will then adjust the type and dose of your phosphate-lowering medications as needed to help you reach the target for your assigned group. This would be part of your regular medical care, so you wouldn't typically have extra hospital visits beyond what you already have for your dialysis.
The study will monitor your health over time, focusing on serious heart events, your physical health, and your general well-being. This will likely involve regular checks that are already part of your usual care, such as blood tests for phosphate levels and discussions about how you're feeling. The total duration of your participation in the study would depend on how long the overall study runs and how long you remain eligible.
Potential risks and benefits
Locations (115)
- Royal Prince Alfred HosptialVerified postcodeCamperdown, Australia· Active not recruiting
- Nepean HospitalVerified postcodeKingswood, Australia· Active not recruiting
- St George HospitalVerified postcodeKogarah, Australia· Active not recruiting
- Royal North Shore HospitalUnverifiedSaint Leonards, Australia· Active not recruiting
- Western Sydney Renal ServiceVerified postcodeWestmead, Australia· Active not recruiting
- Wollongong HospitalVerified postcodeWollongong, Australia· Active not recruiting
- Sunshine Coast University HospitalVerified postcodeBirtinya, Australia· Active not recruiting
- Royal Brisbane and Women's HospitalVerified postcodeBrisbane, Australia· Active not recruiting
- Princess Alexandra HospitalVerified postcodeBrisbane, Australia· Active not recruiting
- Bundaberg HospitalVerified postcodeBundaberg, Australia· Active not recruiting
- Cairns HospitalVerified postcodeCairns, Australia· Active not recruiting
- Fraser Coast Renal ServiceVerified postcodeHervey Bay, Australia· Active not recruiting
Common questions
What exactly is phosphate and why is it important?
Phosphate is a natural mineral in your body. When your kidneys don't work well, too much can build up, which can be harmful, especially for your heart.
How will my doctors know which phosphate level to aim for?
If you join, you'll be randomly put into one of two groups. Your doctors will then adjust your medication to try and keep your phosphate levels within the target range for your group.
Will I have to take new or different medications?
Your doctors will use existing phosphate-lowering medications, deciding which ones and what doses are best to reach your target phosphate level, just as they do now.
What kind of health problems are you looking out for?
The study is mainly interested in seeing if lowering phosphate levels can reduce serious heart events, improve your physical health, and generally make you feel better.
If I join, does it mean I'm getting experimental treatment?
No, both approaches in the study involve managing phosphate levels using standard medications that are already approved. We're just trying to find out which target level is best.
How to find out more
Ron Wald
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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