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.
This study is a prospective, open-label, randomized controlled, multicenter investigation conducted among adult patients with ND-CKD anemia in China, with the aim of exploring the rational hemoglobin target value for the treatment of patients with ND-CKD anemia using enarodustat. This study plans to enrol 1,670 patients with non-dialysis chronic kidney disease (ND-CKD) anemia. After screening, patients who meet the inclusion criteria and do not meet the exclusion criteria will be randomly assigned at a 1:1 ratio to: the low Hb target value group: with a Hb target value of 11 g/dL; the high Hb target value group: with a Hb target value of 13 g/dL. The initial dose of enarodustat tablets in both groups is 4 mg once daily. The dose will be adjusted in accordance with the instructions and the requirements of different Hb value groups. The follow-up period will last for 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,670
Patients are administered with enarodustat with dosage adjusted according to hemoglobin levels to achieve and maintain hemoglobin target over 96 weeks.
Zhongshan hospital, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGImprovement of quality of life
Mean change in 36-Item Short Form Health Survey
Time frame: At week 24
Effect on MACE+ events
First occurence of major adverse cardiovascular + event (MACE+; all-cause mortality, myocardial infarction, stroke, and congestive heart failure requiring hospitalization) .
Time frame: During 96 weeks
Effect on blood transfusions
Difference in the proportion of patients receiving blood transfusions between high- and low-hemoglobin target groups
Time frame: During 96 weeks
Effect on thromboembolic events
Diagnose thromboembolic events through clinical symptoms, laboratory tests, and auxiliary examinations. Compare the variance in the risk of thromboembolic events (excluding those in the cardiovascular system of the heart and brain) between high- and low-hemoglobin target groups
Time frame: During 96 weeks
Effect on MACE events
Diagnose MACE events (death from any cause, non-fatal myocardial infarction, non-fatal stroke)through clinical symptoms, laboratory tests, and auxiliary examinations. Dissimilarity in the risk of the first occurrence of MACE events between high- and low-hemoglobin target groups
Time frame: During 96 weeks
Effect on cardiovascular death
Discrepancy in the risk of cardiovascular death between high- and low-hemoglobin target groups
Time frame: During 96 weeks
Effect on renal events
Divergence in the incidence of renal events (defined as a reduction in eGFR by more than 50%, persistent dialysis for more than 3 months, or kidney transplantation) between high- and low-hemoglobin target groups
Time frame: During 96 weeks
Effect on eGFR
Difference in the mean change of eGFR from baseline between high- and low-hemoglobin target groups
Time frame: At weeks 24, 48, 72, and 96
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