Phase 3 Chronic Kidney Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with anemia related to chronic kidney disease (CKD) at stages 3, 4, or 5 — including those who are not on dialysis, as well as those receiving hemodialysis, peritoneal dialysis, or hemodiafiltration.
• People not on dialysis whose kidneys are filtering at a reduced rate, measured by a specific formula (called the Schwartz formula) giving a result below 60 mL/min per 1.73 m².
• People already being treated with a medication called an ESA (a drug that stimulates red blood cell production) whose hemoglobin level at screening is between 10.0 and 12.0 g/dL, or people who have never been treated with an ESA whose hemoglobin level is 11 g/dL or below.
• People whose iron storage levels (ferritin) are above 100 ng/mL, or whose transferrin saturation (a measure of iron in the blood) is above 20%.
• People whose liver enzyme levels (ALT and AST) and bilirubin levels fall within acceptable ranges at the time of enrolment (confirm with trial site for exact values).
• People who are either currently taking a stable dose of an ESA medication for at least 4 weeks before screening, or who have had little to no prior ESA treatment, as defined by specific timelines (confirm with trial site for exact definitions).
• Female participants who are not pregnant and either cannot become pregnant, or who agree to use reliable contraception from the time of consent until at least 4 weeks after the last dose of the study drug.
• Female participants who agree not to breastfeed from screening through to 4 weeks after the last dose of the study drug.
• Female participants who agree not to donate eggs from the first dose of the study drug through to 4 weeks after the last dose.
• Male participants with a female partner who could become pregnant (including breastfeeding partners) who agree to use contraception throughout treatment and for 4 weeks after the last dose of the study drug.
• Male participants who agree not to donate sperm during treatment and for 4 weeks after the last dose of the study drug.
• Male participants with a pregnant partner who agree to remain abstinent or use a condom for the duration of the pregnancy and for 4 weeks after the last dose of the study drug.
• Participants, and/or their parent or legal guardian, who agree not to join any other interventional clinical trial at the same time as this one.

Who may not be able to join:

• People who have taken part in another clinical trial or received an experimental treatment within 28 days (or longer, depending on the drug) before screening.
• People who have a medical condition — including an active or serious infection — that could make participation unsafe, affect the study results, or interfere with taking part.
• People with a known or suspected allergy or sensitivity to the study drug roxadustat, similar medications (called HIF-PHI inhibitors), or any ingredients in the study drug formulation.
• People with poorly controlled high blood pressure that has not been brought under control in the 2 weeks before screening, based on age-specific blood pressure thresholds (confirm with trial site for exact values).
• People with a known blood disorder other than anemia caused by kidney disease — for example, sickle cell disease or beta thalassemia.
• People with untreated underactive thyroid (hypothyroidism).
• People with severely overactive parathyroid glands, indicated by a parathyroid hormone (PTH) level above 1000 pg/mL within 4 weeks of screening.
• People who have a working transplanted kidney.
• People with a deficiency in folate, vitamin B12, or carnitine, unless these have been treated and corrected to normal levels within 4 weeks of screening.
• People with a known active cancer, or a cancer diagnosis within the 18 months before screening; any prior radiation or chemotherapy must have been completed at least 12 months before screening.
• People who have a scheduled living donor organ transplant planned within 12 weeks of screening.
• People who have received a whole blood or red blood cell transfusion within 8 weeks before screening.
• People who have had significant ongoing blood loss in the 4 weeks before screening.
• People diagnosed with hemolytic uremic syndrome within 12 weeks before screening, or people with a history of atypical hemolytic syndrome who have not been in stable remission for more than 12 weeks before screening.
• People with a history of chronic liver disease, including certain conditions such as autosomal recessive polycystic kidney disease, cystinosis, or primary hyperoxaluria.
• People on peritoneal dialysis who have had a peritonitis infection (infection in the abdomen) within 30 days before screening.
• People with active kidney inflammation (such as lupus nephritis or certain other types of glomerulonephritis) who have required strong anti-inflammatory or immunosuppressive treatment within 6 weeks of screening (confirm with trial site for full details).
• People with a known history of HIV infection.
• People with rare inherited conditions affecting how the body processes certain sugars (galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption), or people with a known allergy to peanut or soya.

Important: Always verify eligibility with the trial site directly before applying.