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 receiving stable dialysis (including haemodialysis, hemodiafiltration, hemofiltration, or peritoneal dialysis) for kidney failure for at least 16 weeks before joining, and whose doctor considers them to be following their dialysis treatment plan.
• People who have been receiving an approved erythropoiesis-stimulating agent (ESA — a type of medication for anaemia) by injection or under the skin for at least 6 weeks before joining.
• People whose haemoglobin (a measure of red blood cells in the blood) averaged between 9.0 and 12.0 g/dL across two blood tests during the screening period.
• People whose liver enzyme levels (AST and ALT) are below three times the upper end of the normal range at screening.
• People whose iron levels meet at least one of these criteria at screening: transferrin saturation of 20% or higher, or ferritin of 100 ng/mL or higher (these are measures of iron in the body).
• People whose folate and vitamin B12 levels are within or above the normal range at screening.

Who may not be able to join:

• People who currently have abnormal blood vessel growth in the retina (back of the eye) that requires treatment.
• People who have a chronic inflammatory condition — other than a kidney disease called glomerulonephritis — that could affect red blood cell production, or who have an active autoimmune disease with inflammatory symptoms.
• People who have had part of their stomach or intestine surgically removed in a way that could affect how oral medications are absorbed, or who currently have a stomach-emptying condition (gastroparesis) with ongoing symptoms despite treatment.
• People with poorly controlled high blood pressure, defined as having more than one reading during screening with a top number above 180 mmHg or a bottom number above 110 mmHg.
• People with moderate to severe heart failure (classified as NYHA Class III or higher).
• People who have had a stroke, mini-stroke (TIA), heart attack, blood clot in a vein (DVT), pulmonary embolism, or lung infarction within 24 weeks before screening.
• People with a history of significant or currently active liver disease.
• People who have a history of seizures or epilepsy, or who have ever had a seizure.
• People whose blood albumin (a protein that reflects nutrition and liver function) is below 2.5 g/dL at screening.
• People who previously experienced significant liver-related side effects from ESA or a related class of anaemia medication called HIF-PHI (confirm with trial site).
• People who have previously had a working organ transplant, are scheduled for an organ transplant, or who have no remaining kidney tissue (anephric).

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