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

NCT06725810 | Recruiting Phase 4 DMC

• 1 other identifier: B2024-443
• Study Type: interventional
• Target: 1,670
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Disease Associated Anemia

Keywords

HIF-PH inhibitor; anemia; chronic kidney disease; quality of Life; major adverse cardiovascular events; enarodustat

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Effect on blood transfusions

  During 96 weeks

• Effect on thromboembolic events

  During 96 weeks

• Effect on MACE events

  During 96 weeks

• Effect on cardiovascular death

  During 96 weeks

• Effect on renal events

  During 96 weeks

Other Outcomes (4)

• Effect on the usage of iron agents

  During 96 weeks

• Effect on the indices of iron metabolism

  at weeks 12, 24, 48, 72, and 96

• Difference of dosage of enarodostat

  During 24 weeks

Study Arms (2)

high-hemoglobin target group

EXPERIMENTAL

Patients are managed to achieve and maintain hemoglobin target of 13 g/dl over 96 weeks.

Drug: Enarodustat

low-hemoglobin target group

EXPERIMENTAL

Patients are managed to achieve and maintain hemoglobin target of 11 g/dl over 96 weeks.

Drug: Enarodustat

Interventions

Enarodustat DRUG

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

high-hemoglobin target group; low-hemoglobin target group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.);

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan hospital, Fudan University

Shanghai, Shanghai Municipality, 200043, China

RECRUITING

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic

Interventions

enarodustat

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiaoqiang Ding

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoqiang Ding

CONTACT

008613816209067; ding.xiaoqiang@zs-hospital.sh.cn

Xiaoyan Zhang

CONTACT

008613918251317; zhang.xiaoyan@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 10, 2024
• Study Start: March 27, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: July 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)