RecruitingPhase 4NCT06725810

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

A Prospective, Open-label, Randomized, Multicenter Study on the Rational Hemoglobin Target Value in Patients With Anemia of Non-dialysis Chronic Kidney Disease Treated With Enarodustat

Sponsor

Shanghai Zhongshan Hospital

Enrollment

1,670 participants

Start Date

Mar 27, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Kidney Disease Associated Anemia

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial tests enarodustat, a new oral pill, to treat anemia (low red blood cell levels) in people with chronic kidney disease who are not yet on dialysis. **You may be eligible if...** - You are 18–75 years old and weigh 45–100 kg - You have been diagnosed with chronic kidney disease (stages 2–5) but are not on dialysis - You have renal anemia with hemoglobin levels within the required range - Your iron levels are adequate for the study **You may NOT be eligible if...** - You have severely uncontrolled high blood pressure - You have very high protein levels in your urine (severe proteinuria) - Your anemia is caused by something other than kidney disease (such as a blood disorder, hemolysis, or cancer) - You have had active bleeding in the past 4 weeks - You have autoimmune diseases known to cause anemia (e.g., lupus, ANCA vasculitis) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEnarodustat

Patients are administered with enarodustat with dosage adjusted according to hemoglobin levels to achieve and maintain hemoglobin target over 96 weeks.

Locations(1)

Zhongshan hospital, Fudan University

Shanghai, Shanghai Municipality, China

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NCT06725810