At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Roxadustat (drug)
- How long the study runs
- Study runs about 45 months (dates as stated)
- About the drug or intervention
- Roxadustat — drug: Oral
- Patient visit burden
- "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." (as stated by sponsor)
- Type of study
- Testing a treatment
- Ages
- 2 Years to 17 Years
- Who
- All
- Number of participants
- 100
- Started
- 2024-01-16
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for chronic kidney disease
- • Phase3 - 100 participants
- • Roxadustat is a licensed medicine to treat anemia in adults with chronic kidney disease (CKD)
Who can take part?
- • Ages 2 Years to 17 Years
- • Diagnosed with chronic kidney disease
Where?
- • Cardiff - Site GB44005
- • Glasgow - Site GB44006
- • Liverpool - Site GB44008
- • London - Site GB44007
- • +3 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 2 Years - 17 Years
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ an estimated glomerular filtration rate (Schwartz formula) of \< 60 mL/min per 1
What the study is looking for
- ✓Participants not on dialysis must have an estimated glomerular filtration rate (Schwartz formula) of \< 60 mL/min...
- ✓ESA-treated participants should have a screening Hb level, assessed via HemoCue, between 10.0 and 12.0 g/dL;...
- ✓Participant has a ferritin level \> 100 ng/mL or a transferrin saturation (TSAT) value \> 20%.
- ✓Participant has an alanine aminotransferase (liver enzymes) and aspartate aminotransferase (liver enzymes) ≤ 2 x upper limit of normal...
- ✓Participant is treated with an ESA or is ESA-naïve, where ESA status is defined as:
Who cannot take part
- ✗Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to...
- ✗Participant has a known or suspected hypersensitivity to roxadustat, related hypoxia-inducible factor-prolyl...
- ✗Participant has untreated hypothyroidism.
- ✗Participant has severe hyperparathyroidism defined as serum parathyroid hormone (PTH) levels above 1000 pg/mL intact...
- ✗Participant has a functioning kidney allograft.
See the full criteria
Where Is This Study? (7 UK sites)
Site GB44005
Cardiff, United Kingdom
Site GB44006
Glasgow, United Kingdom
Site GB44008
Liverpool, United Kingdom
Site GB44007
London, United Kingdom
Site GB44003
Newcastle upon Tyne, United Kingdom
Site GB44001
Nottingham, United Kingdom
Site GB44004
Southampton, United Kingdom
How to Get in Touch
Astellas Pharma Global Development, Inc.
Sponsor contactCONTACT
