Ongoing Clinical Trials for Nephrogenic Anaemia
There is currently 1 ongoing clinical trial investigating new treatments for nephrogenic anaemia, also known as anaemia associated with chronic kidney disease. This trial is testing roxadustat, a medication that helps the body produce more red blood cells, specifically in children and adolescents with chronic kidney disease. The study is being conducted across 20 European countries.
Clinical trial locations
- Belgium
- Bulgaria
- Croatia
- Czechia
- Denmark
- Finland
- France
- Germany
- Greece
- Ireland
- Italy
- Lithuania
- Netherlands
- Norway
- Poland
- Portugal
- Romania
- Slovakia
- Spain
- Sweden
Study on Roxadustat for Treating Anemia in Children with Chronic Kidney Disease
This clinical trial is investigating roxadustat, a medication taken as a tablet, for treating anaemia in children and adolescents with chronic kidney disease. When the kidneys do not work properly, they cannot produce enough of a hormone called erythropoietin, which is essential for making red blood cells. This leads to anaemia, causing symptoms such as tiredness, weakness, and shortness of breath.
Main focus: The study aims to evaluate how well roxadustat works and how safe it is for young patients with this condition. Roxadustat works by helping the body produce more red blood cells naturally. The treatment period lasts 24 weeks, starting with a fixed dose for 4 weeks, followed by 20 weeks where the dose may be adjusted based on how well the patient responds. The study will compare roxadustat to other commonly used treatments such as methoxy polyethylene glycol-epoetin beta, epoetin alfa, and darbepoetin alfa. Some participants may receive a placebo for comparison purposes.
Who can participate:
- Children and adolescents aged between 2 and 18 years
- Diagnosed with anaemia related to chronic kidney disease, whether or not they are on dialysis
- For those not on dialysis, kidney function test results must show less than 60 mL/min per 1.73 m²
- Haemoglobin levels between 10.0 and 12.0 g/dL if already on ESA treatment, or 11 g/dL or less if not previously treated
- Adequate iron stores, with ferritin levels greater than 100 ng/mL or TSAT values greater than 20%
- Liver enzyme levels (ALT and AST) no more than twice the normal limit
- Either currently on a stable dose of ESA for at least 4 weeks, or not treated with ESA recently
- Female participants must agree not to become pregnant and use birth control during the study and for 4 weeks after
- Written consent from the participant or their parent or legal guardian
Who cannot participate:
- Patients with other serious health conditions that could interfere with the study
- Those currently in another clinical trial
- Recent blood transfusion recipients
- Known allergy to roxadustat or its ingredients
- Pregnant or breastfeeding participants
- History of drug or alcohol abuse
- Mental health conditions affecting study participation
- History of not following medical treatments
- Need for medications that could interfere with roxadustat
- History of certain types of cancer
Throughout the study, participants will be closely monitored by healthcare professionals. Regular assessments will include checking haemoglobin levels, evaluating response to the medication, monitoring for side effects such as cardiovascular or thrombotic events, and conducting safety evaluations through laboratory tests and physical examinations. The study may continue to observe participants for up to 52 weeks to gather additional information on the long-term effects and safety of roxadustat. Quality of life and fatigue levels will also be assessed using questionnaires designed for young patients.
Summary
Currently, there is one active clinical trial focusing on nephrogenic anaemia, specifically targeting the paediatric population with chronic kidney disease. The trial is investigating roxadustat, which represents a different approach to treating anaemia compared to traditional treatments. Rather than directly replacing erythropoietin, roxadustat works by inhibiting an enzyme that regulates the body’s natural production of this hormone.
The study has a notably wide geographic reach, being conducted across 20 European countries, which suggests a substantial effort to recruit sufficient participants and gather diverse data. This broad distribution may reflect the specific challenge of conducting paediatric trials, where eligible participants may be harder to find compared to adult studies. The trial’s design includes comparison with established treatments and placebo, which will help determine roxadustat’s effectiveness and safety profile in this young patient group.
