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Clinical Trial Details

Trial ID: L0524
Source ID: NCT06725810
Associated Drug: Enadustat
Title: Correction of Anemia with Enarodustat in Non-dialysis Dependent Chronic Kidney Disease
Acronym: CANNON
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Chronic Kidney Disease Associated Anemia
Interventions: DRUG: enadustat
Outcome Measures: Primary: Improvement of quality of life, Mean change in 36-Item Short Form Health Survey, 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) ., During 96 weeks | Secondary: Effect on blood transfusions, Difference in the proportion of patients receiving blood transfusions between high- and low-hemoglobin target groups, During 96 weeks|Effect on thromboembolic events, 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, During 96 weeks|Effect on MACE events, Dissimilarity in the risk of the first occurrence of MACE events between high- and low-hemoglobin target groups, During 96 weeks|Effect on cardiovascular death, Discrepancy in the risk of cardiovascular death between high- and low-hemoglobin target groups, 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, During 96 weeks|Effect on eGFR, Difference in the mean change of eGFR from baseline between high- and low-hemoglobin target groups, At weeks 24, 48, 72, and 96 | Other: Effect on the usage of iron agents, Difference in the usage of iron agents between high- and low-hemoglobin target groups, During 96 weeks|Effect on the indices of iron metabolism, Difference in the mean changes of ferritin, serum iron and transferrin saturation level from baseline between high- and low-hemoglobin target groups., at weeks 12, 24, 48, 72, and 96|Difference of dosage of enarodostat, Difference of mean dosage of enarodostat between high- and low-hemoglobin target groups, During 24 weeks|Evaluation of adverse drug events, The variance of adverse drug events between high- and low-hemoglobin target groups, during 96 weeks
Sponsor/Collaborators: Sponsor: Shanghai Zhongshan Hospital | Collaborators: Shenzhen Salubris Pharmaceuticals Co., Ltd. (Salubris)
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 1670
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-01
Completion Date: 2029-02-01
Results First Posted:
Last Update Posted: 2024-12-10
Locations: Zhongshan hospital, Fudan University, Shanghai, Shanghai, 200043, China
URL: https://clinicaltrials.gov/show/NCT06725810