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 diagnosed with chronic kidney disease (CKD) at a moderate to severe stage (stage 3, 4, or 5), confirmed by a specific kidney function blood test at the start of the trial.
• People who are not currently on dialysis and who show no signs of needing to start dialysis during the study period.
• People who have either never used certain anaemia medications (called ESAs or HIF-PHIs) in the past 12 weeks and have haemoglobin (a measure of red blood cells) levels within a specific range, OR people who have been regularly using an approved ESA medication for at least 6 weeks before joining, with haemoglobin levels within a different specified range.
• People whose liver enzyme levels (AST and ALT) are below three times the upper limit of the normal range at the screening blood test.
• People whose iron levels, measured by a test called transferrin saturation, are 20% or above, OR whose ferritin (another iron measure) is 100 ng/mL or above at screening.
• People whose folate and vitamin B12 blood levels are at or above the normal lower limit at screening.

Who may not be able to join:

• People who currently have abnormal blood vessel growth in the retina of the eye that requires treatment.
• People who have a long-term inflammatory condition (other than a specific kidney disease called glomerulonephritis) that could affect red blood cell production, or who have an active autoimmune disease causing inflammatory symptoms.
• People who have had part of their stomach or intestine surgically removed in a way that could affect how medications are absorbed, or who have poorly controlled stomach-emptying problems (gastroparesis) even while being treated for it.
• People with poorly controlled high blood pressure, specifically those who have recorded more than one reading with a top number above 180 mmHg or a bottom number above 110 mmHg during the screening period.
• People who have moderate to severe heart failure (classified as New York Heart Association 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 the 24 weeks before screening.
• People who have a history of significant liver disease or who currently have an active liver condition.
• People who have a history of seizures (epilepsy or otherwise) or who have ever experienced a seizure.
• People whose blood albumin (a protein level) is below 2.5 g/dL at screening.
• People whose previous use of ESA or HIF-PHI medications caused certain liver-related blood test results to become significantly abnormal, or who developed serious liver disease as a result of those treatments.
• People who have previously received a functioning organ transplant, who have a transplant scheduled, or who have no functioning kidneys at all.

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