Correction of Anemia With Enarodustat in Non-dialysis Dependent Chronic Kidney Disease (NCT06725810) | Clinical Trial Compass
RecruitingPhase 4
Correction of Anemia With Enarodustat in Non-dialysis Dependent Chronic Kidney Disease
China1,670 participantsStarted 2025-03-27
Plain-language summary
The CANNON trial is a prospective, open-label, randomized, multicenter study designed to investigate rational hemoglobin target value in patients with anemia of non-dialysis chronic kidney disease treated with enarodustat. Eligible patients are randomly assigned 1:1 to the high-hemoglobin target group （hemoglobin of 13 g/dl）and low-hemoglobin target group （hemoglobin of 11 g/dl）and administered with enarodustat to achieve and maintain target hemoglobin over 96 weeks. The first primary endpoint was the difference of mean change in 36-Item Short Form Health Survey at week 24. The second primary endpoint was safety endpoints included time to major adverse cardiovascular + event (MACE+; all-cause mortality, myocardial infarction, stroke, and congestive heart failure requiring hospitalization) during 96 weeks.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Aged 18-75 years at the time of consent to participate;
✓. Body weight ranged from 45 to 100 kg;
✓. Diagnosed with CKD stages 2-5 (10 ≤ eGFR \< 90 mL/min/1.73m2) and were not dialysis dependent;
✓. Diagnosed with renal anemia:
Exclusion criteria
✕. Uncontrolled hypertension identified as systolic blood pressure \>160mmHg or diastolic blood pressure \>100mmHg after 4 weeks of regular and adequate drug therapy prior to screening;
✕. Uncontrolled proteinuria identified as UACR \>3000mg/g or 24-hour urine protein \>3.5g in non-diabetic patients and UACR of \>5000mg/g or 24-hour urine protein \>5.5g in diabetic patients;
✕. Anemia due to other reasons except CKD including systemic hematological disorders (such as myelodysplastic syndrome, aplastic anemia, etc.), hemolytic anemia, hemorrhagic anemia or cancer-related anemia;
✕. History of autoimmune diseases which could result in anemia such as systemic lupus erythematosus and ANCA vasculitis;
✕. History of active bleeding within 4 weeks prior to screening;
✕. History of serious thrombotic event such as a myocardial infarction, cerebral infarction, pulmonary embolism, unstable angina, or PCI or cardiac surgery within 6 months prior to screening;
✕. Severe heart failure (NYHA class IV) at screening;
✕. History of blood transfusion within 2 months prior to screening;