Comparing High and Low Dose Iron Treatments for People on Peritoneal Dialysis: The PALaDIN Study
This study, called PALaDIN, is for people with advanced kidney disease who are receiving peritoneal dialysis and have anaemia. Anaemia is common in kidney disease because the kidneys help make red blood cells. We want to compare what happens when people receive either a high dose or a low dose of iron given directly into their veins (an intravenous drip), or iron tablets you take by mouth. For 12 months, we will be looking at how well their anaemia improves, their symptoms, how they feel day-to-day, their physical fitness, and their thinking abilities. We will also see if they need fewer blood transfusions or changes to other medicines. This early study will help us work out the best ways to measure these changes in the future.
At a glance
What is this study about?
Many people in the UK live with kidney disease. In its most serious form, called end-stage kidney disease, people need treatments like dialysis to help clean their blood. One type of dialysis is called peritoneal dialysis, where a special fluid is put into and taken out of your tummy to help remove toxins. Your kidneys also play a big part in making red blood cells, so when kidneys don't work properly, it often leads to a condition called anaemia, where you don't have enough healthy red blood cells.
This study, called PALaDIN, is looking at different ways to treat anaemia in people who are on peritoneal dialysis. Iron is very important for making red blood cells, so iron treatments are often given. We want to compare whether a high dose or a low dose of iron given through a drip, or iron tablets taken by mouth, works best. This is an important step to make sure we're using the most effective and helpful ways to manage anaemia for people with kidney disease.
Over a year, we will carefully check how these different iron treatments affect various aspects of your health. This includes how much your anaemia improves, whether your symptoms get better, your general quality of life, how well you can do physical activities (like walking for a certain time), and even your concentration and memory. We'll also be tracking if people need fewer blood transfusions and how they respond to other medicines that help produce blood cells. By doing this, we hope to find out which treatment plan is most beneficial for people like you.
Key takeaways
- This study compares different iron treatments for anaemia in people on peritoneal dialysis.
- It aims to find the best dose and way to give iron to improve health and quality of life.
- You might receive iron through a drip or as tablets.
- The study lasts for 12 months with regular health checks.
- Your symptoms, physical fitness, and general well-being will be monitored.
Who may be eligible?
To join this study, you need to be an adult (18 years or older) and currently receiving peritoneal dialysis for at least four weeks. You should also expect to continue peritoneal dialysis for the whole study period. We'll check your iron levels to make sure they're in a specific range that means you could benefit from extra iron, and you shouldn't have had iron given through a drip in the last four weeks.
There are some reasons why you might not be able to join. For example, if your doctor thinks your dialysis isn't working well enough, or if you might need a blood transfusion very soon. You also can't join if you have certain other serious health problems, such as a severe infection, or if you've recently been in another medical study involving new medicines. We also need to make sure you don't have an allergy to iron medicines.
Before you can take part, you'll have a proper chat with the study team. They will make sure the study is right for you and that you understand everything involved. If you're a woman who could become pregnant, you'd need to be using effective contraception during the study.
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 18 years old or older?
- Have you been on peritoneal dialysis for at least 4 weeks and expect to continue?
- Have you *not* had iron through a drip in the last 4 weeks?
- Do you have good overall health, without severe infections, or other specific serious conditions?
- Are you able to agree to take part and follow the study plan?
What does participation involve?
If you decide to take part, you'll be randomly assigned to one of three groups, meaning you'll receive either: a high dose of iron through a drip, a low dose of iron through a drip, or iron tablets by mouth. The study will last for 12 months. During this time, you'll have regular hospital visits for assessments. These will involve blood tests to monitor your anaemia and iron levels, and discussions about your symptoms and how you're feeling. You might also be asked to do some simple physical tests, like a walking test, and complete questionnaires about your quality of life and thinking abilities. The study team will be there to support you throughout and answer any questions. You can choose to leave the study at any time.
Potential risks and benefits
Locations (1)
- Hull University Teaching Hospitals NHS TrustVerified postcodeHull, United Kingdom· Recruiting
Common questions
What is peritoneal dialysis?
Peritoneal dialysis is a way to clean your blood when your kidneys aren't working. It uses a natural filter inside your tummy to remove waste products and extra fluid from your body.
What is anaemia?
Anaemia means you don't have enough healthy red blood cells to carry oxygen around your body. It can make you feel tired, weak, and short of breath.
What are the different iron treatments in this study?
You could receive a higher or lower dose of iron given through a drip into your vein (called intravenous iron), or iron tablets that you take by mouth.
How long will the study last?
If you join, you will be part of the study for 12 months.
Can I stop being in the study if I change my mind?
Yes, you can leave the study at any time, for any reason. Your decision will not affect your normal medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.