Phase 3 Chronic Kidney Disease Trial, Recruiting

Written by an AI model from the 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 aged 18 or older
• People who have given their written, voluntary agreement to take part after being fully informed about the study and having the chance to ask questions
• People with advanced (stage 5) chronic kidney disease, with a kidney function measurement (eGFR) of 15 or below, who have been on regular haemodialysis (kidney dialysis) for at least 12 weeks before the study starts
• People on haemodialysis whose dialysis treatment is delivering adequate results, measured by specific blood-cleaning efficiency tests (confirm with trial site for exact values)
• People who have been receiving stable doses of injections of a red blood cell–stimulating medication (called an ESA) for at least 6 weeks before the study starts, at or above a minimum dose level depending on which ESA is being used (confirm with trial site for specific doses)
• People whose haemoglobin (a measure of red blood cells in the blood) falls between 9.0 and 12.0 g/dL on average across two recent blood tests taken at least 6 days apart, with the two results being within 1.5 g/dL of each other
• People with adequate iron stores, shown by a blood ferritin level of at least 100 ng/mL at screening
• People with adequate iron availability in the blood, shown by a transferrin saturation (TSAT) level of at least 20% at screening
• People with folate (a B vitamin) levels in the blood at or above the normal lower limit at screening
• People with vitamin B12 levels in the blood at or above the normal lower limit at screening

Who may not be able to join:

• People with an active or uncontrolled infection, or an uncontrolled inflammatory condition (other than a specific kidney-related condition called glomerulonephritis) that could affect red blood cell production, or with a high level of a blood inflammation marker called C-reactive protein
• People with active hepatitis B or hepatitis C infection, or a chronic hepatitis B or C infection where liver function test results are more than three times the normal upper limit, or people known to be HIV positive
• People with a history or current signs of significant heart, blood, liver, or other physical health conditions that the study doctor considers would make participation unsafe
• People with certain abnormal liver blood test results at screening (ALT, AST, or total bilirubin above specific threshold levels)
• People with severe heart failure (classified as New York Heart Association class III or IV)
• People considered at high risk of serious events such as heart attack, severe or unstable heart disease, stroke, or severe liver disease, particularly if such events occurred within the 12 weeks before or during screening
• People with uncontrolled high blood pressure, specifically a sitting systolic reading of 170 mmHg or higher and/or a diastolic reading of 100 mmHg or higher
• People with a history of active cancer, unless the cancer has been in full remission or considered cured for 5 or more years, or unless it was a type of skin cancer that was fully removed, or an in-place (in situ) cancer
• People who have had significant gastrointestinal bleeding or any major bleeding episode that caused their haemoglobin to drop by 1 g/dL or more in the 8 weeks before screening
• People with a history of certain blood or bone marrow disorders, including myelodysplastic syndrome, multiple myeloma, thalassaemia, sickle cell anaemia, pure red cell aplasia, iron overload conditions, known clotting disorders, or any known cause of anaemia other than kidney disease
• People who have previously had a functioning organ transplant, are scheduled for an organ transplant, or who have had one or both kidneys removed
• People who are planning surgery during the study period that could result in significant blood loss
• People with low blood albumin (a protein) levels below 2.5 g/dL at screening
• People who have received certain medications — including androgens, or iron-chelating drugs such as deferoxamine, deferiprone, or deferasirox — within 12 weeks before the study starts
• People with a life expectancy of less than 12 months
• People with a cognitive or psychiatric condition that would prevent them from being able to fully participate in and complete the study
• People with a known allergy or sensitivity to any of the study medications or their ingredients
• People who have received a blood transfusion in the 12 weeks before screening, or for whom a blood transfusion is expected to be needed during the study (except in emergency situations such as an accident or surgery)
• People who have received certain immune-suppressing medications (such as tacrolimus or cyclosporine) within 12 weeks before the study starts
• People with a history of alcohol or drug misuse in the past 2 years, or who are unable or unwilling to limit alcohol consumption to no more than 3 drinks per day
• People who are currently participating in another clinical trial or have recently received an investigational treatment whose effects may still be present
• Women who are able to become pregnant, or men who are unable or unwilling to use adequate contraception as defined by the protocol during the study and for a specified period afterwards; women who are pregnant, planning to become pregnant in the next 12 months, or currently breastfeeding
• People who work at the study site or for the study sponsor and are directly involved in running this trial, as well as their family members
• People whose overall health condition means that raising haemoglobin to the target level of 12 g/dL may carry more risk than benefit (confirm with trial site)
• People weighing more than 150 kg, or anyone with a medical condition that in the study doctor's opinion could create safety concerns, affect the reliability of study results, or interfere with participation

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