A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease
This study is testing a medicine called roxadustat to treat low red blood cells (anemia) in children and teenagers who have kidney disease. Currently, people with anemia often get injections to help their bodies make more red blood cells. Roxadustat is a pill, which could be an easier way to get treatment. The study will look at how well roxadustat works in these young people over about a year. Both those already on injections and those not yet treated for anemia can take part. Researchers want to find the best dose and see if it's a safe and effective option.
At a glance
What is this study about?
This study is looking at a new way to treat a common problem called anemia in children and teenagers who have long-term kidney disease. Anemia means having too few red blood cells, which can make you feel very tired and unwell. Usually, people with kidney disease who have anemia get injections to help their bodies produce more red blood cells. While these injections work, sometimes there are concerns about their safety, and getting injections regularly can be difficult.
That's where a medicine called roxadustat comes in. It's already approved for adults with kidney disease and anemia, and the good news is, it's a pill! This study wants to find out if roxadustat can be a safe and effective pill option for children and teenagers. The main goal is to understand how well roxadustat fixes anemia in these young people and to figure out the right dose for them.
In this study, everyone who takes part will receive roxadustat. Some children and teenagers who are currently getting injections for their anemia will switch to roxadustat. Others who haven't had treatment for their anemia yet will start taking roxadustat. This will help doctors learn more about this medication and whether it can become a helpful new treatment choice for young people with kidney disease and anemia.
Key takeaways
- This study tests a pill (roxadustat) for anemia in children/teenagers with kidney disease.
- It aims to find a new, potentially easier, treatment option than injections.
- Participants will take roxadustat for up to a year, with regular check-ups.
- The study doctors will carefully monitor health and blood levels.
- All participants receive roxadustat; no one gets a dummy pill.
Who may be eligible?
To join this study, people need to be between 2 and 17 years old and have a diagnosis of kidney disease causing anemia. This includes those who are on dialysis (a treatment that cleans the blood) and those who are not.
Your blood tests will also need to show specific levels of red blood cells (hemoglobin) and iron. Whether you're currently taking other medicines for anemia or not might also affect if you can join. There are also rules about liver health, and for female participants, about not being pregnant or breastfeeding and using effective birth control if needed.
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 between 2 and 17 years old?
- Do you have long-term kidney disease and anemia?
- Are your blood test results for red blood cells and iron within specific ranges?
- If you are female, are you not pregnant or breastfeeding, and using birth control if needed?
- Are your liver blood tests within an acceptable range?
What does participation involve?
If you take part, you'll be taking roxadustat pills three times a week for up to 52 weeks (about one year). For the first four weeks, everyone will start on a set dose. After that, your dose might be adjusted based on your blood test results to keep your red blood cell levels just right.
There will be many clinic visits. For the first four weeks, you'll visit every two weeks. After that, visits will be every four weeks until the end of the treatment period. There's also one final visit four weeks after you stop taking the medicine. During these visits, doctors will check your blood pressure, temperature, and heart rate. They'll take blood and urine samples and do medical check-ups to see how you're doing. You'll also have heart tests (ECGs) at certain visits.
Potential risks and benefits
Locations (47)
- Site BE32002Verified postcodeBrussels, Belgium· Recruiting
- Site BE32001Verified postcodeEdegem, Belgium· Recruiting
- Site BE32004Verified postcodeGhent, Belgium· Recruiting
- Site BE32003Verified postcodeLeuven, Belgium· Recruiting
- Site BG35901Verified postcodeSofia, Bulgaria· Recruiting
- Site HR38501Verified postcodeZagreb, Croatia· Recruiting
- Site HR38503Verified postcodeZagreb, Croatia· Recruiting
- Site CZ42002Verified postcodeBrno, Czechia· Recruiting
- Site CZ42001Verified postcodePrague, Czechia· Recruiting
- Site DK45001Verified postcodeAarhus, Denmark· Recruiting
- Site FI35801Verified postcodeHelsinki, Finland· Recruiting
- Site DE49001Verified postcodeTübingen, Germany· Recruiting
Common questions
What is anemia?
Anemia means you have too few red blood cells, which carry oxygen around your body, making you feel tired and weak.
What is roxadustat?
Roxadustat is a medicine that helps your body make more red blood cells. For this study, it's given as a pill.
Will I get a placebo (dummy pill)?
No, in this study, everyone will receive the roxadustat medicine, and everyone involved will know you are taking it.
How long will I take the medicine for?
You will take roxadustat pills three times a week for up to 52 weeks (about one year).
Are there many clinic visits?
Yes, there will be regular visits – every two weeks for the first month, then every four weeks, plus a final visit after treatment.
How to find out more
Astellas Pharma Global Development, Inc.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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