Correction of Anemia With Enarodustat in Non-dialysis Dependent Chronic Kidney Disease

Recruiting now · Phase 4

Conditions studied: Chronic Kidney Disease Associated Anemia

In brief

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.

Key facts

Study ID: NCT06725810
Run by: Shanghai Zhongshan Hospital
People needed: 1670
Starts: 2025-03-27
Expected to finish: 2029-02-01
Last updated by the study team: 2025-07-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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:
Hemoglobin level of 6 - 10 g/dL for those who have not received ESA or HIF-PHI treatment within 6 weeks at screening; 2)Hemoglobin level of 8 - 12 g/dL for those who are currently receiving ESA (ESA dosage ≤ 10,000 IU/week) or HIF-PHI (roxadustat dosage≤ 100 mg TIW) at screening; 5. Serum ferritin > 100 μg/L or transferrin saturation > 20% at screening; 6. Voluntary participation in the trial and signing of the informed consent form.

You may not qualify if…

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;
History of usage of immunosuppressants or other immune therapies within 6 months prior to screening;
Patients who are estimated to require dialysis, kidney transplantation, or major surgery within 6 months;
Severe liver and biliary system complications (AST or ALT >3 times the upper limit of normal, total bilirubin >2 times the upper limit of normal) at screening;
Receiving ESA combined with roxadustat treatment at screening;
History of proliferative retinopathy or diabetic retinopathy requiring ophthalmological treatment;
Severe hyperparathyroidism (iPTH ≥ 500 pg/mL);
Severe active infections (such as active tuberculosis, fungal infections, etc.);
Patients who are bedridden or have difficulty walking, or have a history of atrial fibrillation or deep vein thrombosis of the lower limbs;
History of active tumors;
Female patients who are pregnant or breastfeeding, or non-childbearing women who do not agree to effective contraception;
Patients with a history of severe drug allergies (such as anaphylactic shock), or known allergies to any of the active ingredients or excipients of enarodostat;
Patients who are currently participating in any other interventional clinical trial;
Other reasons determined by the investigator not suitable for participation in the study.

Where it is running

Zhongshan hospital, Fudan University — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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