Phase 4 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 18 or older, of any gender
• People who have been diagnosed with anaemia caused by chronic kidney disease (CKD), with a haemoglobin level between 7.0 and 11.0 g/dL at the start of the trial
• People who are able to understand the study information and agree to take part
• People who do not have a significant deficiency in folate or Vitamin B12
• Women who could become pregnant must agree to use an approved form of contraception from the screening stage through to the end of the study
• People on haemodialysis who have been receiving it at least twice a week for at least 12 weeks before the screening visit, and who have a suitable access point for dialysis (such as a fistula, graft, or catheter)
• People on haemodialysis who have either not received certain red blood cell-stimulating medications (called ESAs, including Epoetin, Darbepoetin, or Mircera) for a set period before screening, OR who have been on a stable dose of these medications for at least 4 weeks before joining (confirm with trial site for specific timeframes)

Who may not be able to join:

• People who have received a red blood cell transfusion within 8 weeks before joining the trial
• People who are not yet on dialysis and have used ESA medications within 6 weeks before joining
• People with diabetes whose HbA1c (a measure of long-term blood sugar control) is above 9%
• People with high blood pressure that is uncontrolled, or where the readings are above 160 (systolic) or 100 (diastolic) mmHg
• People with a history of cancer, a kidney transplant, severe allergic reactions to the study medications or their ingredients, or certain ongoing inflammatory conditions such as rheumatoid arthritis, coeliac disease, ulcerative colitis, Crohn's disease, or lupus (SLE)
• People with active Hepatitis B, Hepatitis C, or HIV infection
• People with certain uncontrolled blood or immune conditions such as autoimmune haemolytic anaemia, ITP, thalassemia, or bleeding disorders, or those receiving blood-thinning medications such as warfarin within 28 days of the first study dose
• People who have had major surgery within 90 days, or minor surgery within 30 days, before joining
• People who are unable to swallow tablets, or who have conditions that significantly affect how the gut absorbs medication (such as removal of part of the small bowel or poorly controlled inflammatory bowel disease)
• People who have had a heart attack, stroke, or bleeding in the brain within 6 months before joining
• People with significant active heart conditions, such as uncontrolled irregular heartbeat, heart failure, or moderate-to-severe heart disease (Class 3 or 4 as defined by medical classification)
• People with any other serious or life-threatening illness, medical condition, or abnormal test results that the study doctor believes could put them at risk
• People with a significant history of alcohol or drug misuse in the past year, or who smoke more than 10 cigarettes per day or use tobacco or nicotine products more than 10 times per day
• People who have had difficulty donating blood in the past
• People who have had significant abnormal heart rhythm findings (on an ECG) during screening
• People who have taken part in another clinical drug trial within the past 3 months
• Women who have been pregnant or breastfeeding in the past 3 months, are currently pregnant or breastfeeding, are not using adequate contraception, are within one year of menopause without adequate contraception, or are taking oral hormone replacement therapy, or who test positive for pregnancy at screening
• People whose blood test results at screening show abnormally low white blood cell counts or platelet counts, or elevated liver or bilirubin levels beyond the thresholds set by the trial

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