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 aged between 18 and 75 years, of any gender
• People who weigh at least 45 kg and have a body mass index (BMI) of 18.5 or above
• People who have been diagnosed with chronic kidney failure and have been on a stable dialysis routine (either peritoneal dialysis or hemodialysis) for at least 12 weeks before joining, with no plans to change their dialysis type during the trial
• People whose dialysis is working well enough, as measured by a specific test called Kt/V (the trial site can confirm what the required result means for each dialysis type)
• People who are currently taking a medication called Roxadustat at a dose of no more than 360 mg per week, and whose dose has been stable in the 4 weeks before joining
• People whose hemoglobin (a measure of red blood cells) has been tested twice in the 4 weeks before joining, with both results falling between 8.0 and 12.0 g/dL, the two results being close to each other, and the tests taken at least 7 days apart
• People whose iron levels, folate, and vitamin B12 are all at or above the minimum acceptable levels at the time of screening
• People who understand what the study involves and are willing to sign a consent form

Who may not be able to join:

• People with known autoimmune conditions, blood disorders (such as thalassemia, anemia caused by bone marrow problems, or clotting disorders), or any cause of anemia other than kidney disease (such as bleeding in the gut or a parasitic infection)
• People who have been diagnosed with HIV/AIDS, syphilis, or tuberculosis and are currently receiving treatment for these conditions
• People with a known allergy to iron medications or to a substance called polyethylene glycol
• People who have used a combination of two specific types of anemia medications (ESAs and HIF-PHIs) within the 8 weeks before joining
• People who have received a red blood cell or whole blood transfusion within the 12 weeks before joining
• People with poorly controlled blood pressure, including those whose blood pressure readings have been very high on two or more occasions during screening, or where the treating doctor considers blood pressure medication needs to be adjusted
• People with active hepatitis or certain abnormal liver test results during screening, including low blood protein (albumin) levels
• People whose parathyroid hormone levels are very high (above 800 pg/mL) or whose parathyroid condition is considered uncontrolled or causing symptoms, as judged by the investigator
• People with a high level of inflammation in the body, shown by a C-reactive protein result of 30 mg/L or above during screening
• People whose heart function has been assessed as significantly reduced (classified as NYHA Class III or IV) during screening
• People who are pregnant, breastfeeding, or planning to become pregnant during the trial
• People who plan to have a kidney transplant during the trial, who have previously donated a kidney, or who plan to have any scheduled (non-emergency) surgery during the trial period
• People whom the investigator considers unsuitable for any other reason

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