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:

• Adults between 18 and 75 years of age at the time of signing the consent form
• People with a documented diagnosis of end-stage kidney disease
• People who have been receiving dialysis for at least the 90 days before signing the consent form
• People on haemodialysis who receive treatment at least 3 times per week, totalling at least 12 hours per week
• People with documented use of a specific type of red blood cell stimulating medication (epoetin alfa, epoetin beta, or darbepoetin alfa) for at least 90 days before signing the consent form
• People whose dose of that red blood cell stimulating medication has remained stable for at least 90 days before signing the consent form and throughout the screening period
• People whose haemoglobin (a measure of red blood cells) falls within a specific target range (100–120 g/L) based on two screening measurements
• People whose dialysis is working effectively enough to meet specific efficiency thresholds measured at screening or within 14 days before signing the consent form (confirm with trial site)
• People with adequate iron levels in the blood at screening (transferrin saturation of at least 20% and ferritin above 100 ng/mL)
• People with normal vitamin B12 and folic acid levels at screening
• People willing to use contraception throughout the study and for 90 days after the last dose, and to avoid donating eggs or sperm during that period (applies to people of childbearing potential and their partners)
• People who, in the investigator's opinion, are able to follow the study requirements

Who may not be able to join:

• People with any form of anaemia other than anaemia caused by kidney disease, including those with elevated inflammation markers (C-reactive protein above 20 mg/L at screening)
• People with a diagnosis of lupus nephritis or kidney disease caused by systemic vasculitis
• People with a low platelet count (below 100×10⁹/L) at screening
• People who have a kidney transplant already planned and scheduled during the expected study period
• People with a history of severe allergic reactions, or known allergy or sensitivity to the study medications or their ingredients, including polyethylene glycol or iron sucrose
• People who received a vaccination less than 8 weeks before signing the consent form
• People with a diagnosis of liver cirrhosis
• People with HIV infection
• People with significantly elevated liver enzyme levels (ALT or AST more than 3 times the upper limit of normal) at screening
• People with severe heart failure (classified as NYHA Class IV) (confirm with trial site)
• People with resistant high blood pressure that does not respond to treatment
• People with unstable angina (chest pain that is not well controlled)
• People with a history of episodes of acute haemolysis (rapid breakdown of red blood cells)
• People with documented blood or bone marrow conditions including haemoglobin disorders, myelodysplastic syndrome, blood cancers, or pure red cell aplasia
• People with severely overactive parathyroid glands (intact PTH above 1000 pg/mL at screening) or biopsy-confirmed bone marrow scarring
• People with documented bleeding from the gut or elsewhere within the 90 days before signing the consent form
• People with a history of certain blood clot-related events (such as heart attack, stroke, deep vein thrombosis, or pulmonary embolism) within 6 months before signing the consent form, or a blockage in a dialysis access point within 30 days before signing
• People with a history of seizures or epilepsy, including during the screening period
• People who have had major surgery within 30 days before signing the consent form
• People who received a blood transfusion within 90 days before signing the consent form
• People with any active acute or chronic infection, or other chronic conditions that the investigator believes could put the person at risk during the study
• People with a history of severe depression, suicidal thoughts, or suicide attempts
• People with a current or past cancer diagnosis, except for certain fully treated skin or cervical cancers in remission for more than 5 years at the time of signing the consent form
• People with known or currently evident alcohol or drug dependency that the investigator considers a contraindication or likely to affect adherence to the study
• People who have participated in another clinical drug trial within 90 days before signing the consent form
• People who are pregnant or breastfeeding

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