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 have been diagnosed with moderate to severe chronic kidney disease (CKD stage 3, 4, or 5, as measured by a specific kidney function test)
• If you are not currently using ESAs (red blood cell-boosting injections), you have not used them in the past 6 weeks, and your hemoglobin (a measure of red blood cells) falls within a specific range at two check-in points
• If you are currently using ESAs, you have been using them consistently for the past 6 weeks, and your hemoglobin falls within a specific range at two check-in points
• You took a practice/placebo pill during a lead-in period and took between 80% and 120% of the doses as instructed
• You are able to give your signed agreement to take part and follow the study rules

Who may not be able to join:

• You are currently on dialysis, or your doctors expect you will need to start dialysis within 90 days
• You have a kidney transplant planned within the next 52 weeks
• Your iron storage levels (ferritin) are too low, as shown by a blood test at screening
• Your iron transport levels (transferrin saturation) are too low at screening (confirm with trial site)
• You have a history of bone marrow failure or a condition where your body stops making red blood cells
• You have an untreated condition causing anemia, such as pernicious anemia, thalassemia major, sickle cell disease, or a bone marrow disorder called myelodysplastic syndrome
• You have had active bleeding in your stomach, small intestine, or food pipe within the past 4 weeks
• You have had a heart attack or acute heart problem within the past 4 weeks
• You have had a stroke or mini-stroke (TIA) within the past 4 weeks
• You have the most severe category of heart failure (Class IV), meaning you are unable to carry out any physical activity without discomfort
• You currently have high blood pressure that is not under control, as decided by the study doctor
• A specific heart rhythm measurement (QT interval) on your heart tracing (ECG) is above a certain level (confirm with trial site)
• Your liver enzyme levels (ALT) are more than twice the normal upper limit at screening
• Your bilirubin levels (a liver marker) are more than 1.5 times the normal upper limit at screening
• You have active, unstable liver or bile duct disease, shown by symptoms such as fluid in the abdomen, confusion, jaundice, or cirrhosis
• You have been diagnosed with cancer in the past 2 years, are currently being treated for cancer, or have a complex kidney cyst above a certain size — except for certain minor skin cancers that were fully treated at least 4 weeks before screening
• You have a history of severe allergic reactions to any ingredients in the study drug or to a medicine called darbepoetin alfa
• You are currently taking certain specific medicines that strongly affect how the study drug is processed in your body (such as gemfibrozil or rifampin — confirm with trial site)
• You are taking part in, or have recently taken part in, another clinical trial involving an experimental treatment
• You have previously taken the study drug (daprodustat) for more than 30 days
• You are pregnant, breastfeeding, or are able to become pregnant and are not willing to use an approved form of contraception during the study
• You have any other medical condition, lab result, or finding that the study doctor believes would put you at unacceptable risk or prevent you from safely taking part

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