A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease
Status:
Recruiting
Trial end date:
2026-06-30
Target enrollment:
Participant gender:
Summary
Roxadustat is a licensed medicine to treat anemia in adults with chronic kidney disease
(CKD). Anemia is a low level of red blood cells. Current treatment for anemia is to have
injections of medicines called erythropoietin stimulating agents (also known as ESAs) to help
the bone marrow make more red blood cells. These are often given together with iron. This
treatment is also available to children and teenagers with CKD. However, there are some
safety concerns with ESAs. Also, as roxadustat is taken orally, this may be another option
for treating anemia in children and teenagers with CKD. In this study, children and teenagers
with CKD and anemia will take roxadustat for up to 52 weeks to treat their anemia.
The main aim of the study is to learn how roxadustat affects anemia in children and teenagers
with CKD.
This is an open-label study which means the children and teenagers in the study and the
clinic staff know they will be taking roxadustat. In this study, the children and teenagers
with CKD who need treatment for anemia can take part. Those currently being treated with an
ESA will be switched to roxadustat. Those who have not been treated with an ESA can start on
roxadustat straight away. All children and teenagers in the study will take roxadustat 3
times a week for up to 52 weeks (1 year). They will start on a fixed dose of roxadustat for 4
weeks. Blood samples will be taken regularly to check hemoglobin levels. The roxadustat dose
may be changed if the blood levels of hemoglobin are too high, too low, or change too
quickly. After 4 weeks the dose may be changed, if needed, to keep blood levels of hemoglobin
in the blood to just below the normal range.
Firstly, teenagers will take roxadustat. 10 teenagers will take their fixed dose of
roxadustat for 4 weeks. They will give blood samples to help the researchers work out the
most suitable dose for the rest of the teenagers in the study. When the rest of the teenagers
start taking roxadustat at the most suitable dose for teenagers, 10 children will take
roxadustat for 4 weeks. These 10 children will give blood samples to help the researchers
work out the most suitable dose for the rest of the children in the study. Then, the rest of
the children will take roxadustat at the most suitable dose for children.
There will be many clinic visits during the study. Overnight hospital stays are not expected.
There will be 1 visit every 2 weeks for the first 4 weeks of taking roxadustat, then every 4
weeks until the end of treatment. Finally there is 1 visit 4 weeks after treatment has
finished.
During most visits, the children and teenagers will have their vital signs checked (blood
pressure, body temperature and heart rate). Fluid status (how much water is in the body) will
also be checked for those who need dialysis. The children and teenagers will also have blood
tests and the study doctors will check for any medical problems. The children and teenagers
will have a medical examination before their first dose of roxadustat and again at about
24-week (6-month) and 52-week (13-month) visits. They will have an electrocardiogram (ECG)
before their first dose of roxadustat and again at the 12-week, 24-week, 36-week, and 52-week
visit. They will also have urine tests at the 4-week, 24-week and 52-week visits. At the
52-week visit, the children and teenagers will also have blood tests for hemoglobin and iron
levels. The study doctors will also check for any medical problems.