Phase 3 Chronic Kidney Disease Trial, Completed

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:

• You are between 18 and 99 years old.
• You are planning to start regular dialysis within the next 6 weeks, OR you have already been on dialysis for no more than 90 days and are not expected to stop during the study — this includes hemodialysis at least twice a week, or peritoneal dialysis (including CAPD and APD) at least 4 times a week.
• Your hemoglobin (a measure of red blood cells) falls within a specific range at both your screening and enrollment appointments — the trial team will check this with a blood test.
• You are able to understand and sign a consent form agreeing to follow the study rules.

Who may not be able to join:

• You are planning to receive a kidney transplant from a living donor during the study.
• Your iron stores (measured by a protein called ferritin) or iron levels in your blood (called transferrin saturation) are too low, even after receiving iron treatment.
• Your vitamin B12 level is below the normal range, even after vitamin B12 supplementation.
• Your folate (a type of B vitamin) level in your blood is below a certain minimum level.
• You have a history of bone marrow failure or a condition where your body stops making red blood cells (called pure red cell aplasia).
• You have certain untreated blood or bone marrow conditions, including pernicious anemia, thalassemia major, sickle cell disease, or myelodysplastic syndrome.
• You have active bleeding ulcers in your stomach, small intestine, or food pipe, or you have had significant gastrointestinal bleeding in the 10 weeks before screening.
• You have used certain medications to stimulate red blood cell production (called ESAs) within 8 weeks before screening, except for very limited use when starting dialysis (the trial team can clarify the exact limits).
• You have had a heart attack or a serious heart event in the 10 weeks before screening through to the day you would join the trial.
• You have had a stroke or a mini-stroke (transient ischemic attack) in the 10 weeks before screening through to the day you would join the trial.
• You have severe heart failure classified as the most serious level (Class IV) by your doctor.
• You have high blood pressure that is currently not under control in a way that would make a certain type of anemia medication unsafe for you (confirm with trial site).
• Your heart's electrical activity (measured by an ECG) shows a specific abnormality above a set threshold — the trial team will check this.
• You have significant liver problems, including certain abnormal liver blood test results, or active liver disease with serious symptoms such as fluid in the abdomen, yellowing of the skin, or cirrhosis. (Stable, mild liver conditions like hepatitis B or C without serious symptoms may still be acceptable — confirm with trial site.)
• You have been diagnosed with cancer in the past 2 years, are currently receiving cancer treatment, or have a complex kidney cyst of a certain size — with an exception for certain minor skin cancers treated at least 10 weeks before screening.
• You have had a severe allergic reaction to the study drug or similar medications in the past.
• You are currently taking certain medications that strongly affect how the body processes drugs (specifically strong CYP2C8 inhibitors like gemfibrozil, or strong CYP2C8 inducers like rifampin) (confirm with trial site).
• You are currently taking part in another clinical trial or have used another experimental treatment recently (within 30 days or five half-lives of the drug, whichever is longer).
• You have previously taken the study drug (daprodustat) for more than 30 days.
• If you are female: you are pregnant, breastfeeding, or able to become pregnant and are not willing to use a highly effective form of contraception as required by the study.
• You have any other health condition, abnormal test result, or circumstance that the trial doctor believes would put you at unacceptable risk or prevent you from safely taking part in the study.

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