Chronic Kidney Disease Associated AnemiaPhase 4CANNONNCT06725810
Correction of Anemia With Enarodustat in Non-dialysis Dependent Chronic Kidney Disease
A Phase 4 study testing Enarodustat in people with Chronic Kidney Disease Associated Anemia, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Disease Associated Anemia
- What is being tested?
- Enarodustat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,670 participants
- Where
- 1 siteChina
- Study dates
- 27 Mar 2025to 1 Feb 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 1)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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan hospital, Fudan University
Shanghai, Shanghai Municipality, 200043
Xiaoqiang Ding, 0086021-64041990, ding.xiaoqiang@zs-hospital.sh.cn
Xiaoqiang Ding
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Chronic Kidney Disease Associated Anemia
- Being tested
- Enarodustat
- Keywords
- HIF-PH inhibitor, anemia, chronic kidney disease, quality of Life, major adverse cardiovascular events, enarodustat
- Medical subject headings
- Anemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnarodustatDrug
Patients are administered with enarodustat with dosage adjusted according to hemoglobin levels to achieve and maintain hemoglobin target over 96 weeks.
| Study group | Role | What they receive |
|---|---|---|
| high-hemoglobin target group | Experimental | Patients are managed to achieve and maintain hemoglobin target of 13 g/dl over 96 weeks. Receives: Drug: Enarodustat |
| low-hemoglobin target group | Experimental | Patients are managed to achieve and maintain hemoglobin target of 11 g/dl over 96 weeks. Receives: Drug: Enarodustat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of quality of life
Mean change in 36-Item Short Form Health Survey
Measured: 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) .
Measured: During 96 weeks
Secondary outcomes (6)
Effect on blood transfusions
Difference in the proportion of patients receiving blood transfusions between high- and low-hemoglobin target groups
Measured: 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
Measured: 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
Measured: During 96 weeks
Effect on cardiovascular death
Discrepancy in the risk of cardiovascular death between high- and low-hemoglobin target groups
Measured: 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
Measured: During 96 weeks
Effect on eGFR
Difference in the mean change of eGFR from baseline between high- and low-hemoglobin target groups
Measured: At weeks 24, 48, 72, and 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start27 Mar 2025
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Associated AnemiaStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,670 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaoqiang Ding, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725810
- Sponsor's protocol ID
- B2024-443
- Acronym
- CANNON
- Status last verified
- Feb 2025
- First submitted
- 5 Dec 2024
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06725810
- Acronym / sponsor ID
- CANNON / B2024-443
- Conditions
- Chronic Kidney Disease Associated Anemia
- Keywords
- HIF-PH inhibitor, anemia, chronic kidney disease, quality of Life, major adverse cardiovascular events, enarodustat
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,670 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high-hemoglobin target group | Experimental | Drug: EnarodustatPatients are managed to achieve and maintain hemoglobin target of 13 g/dl over 96 weeks. |
| low-hemoglobin target group | Experimental | Drug: EnarodustatPatients are managed to achieve and maintain hemoglobin target of 11 g/dl over 96 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
- 1)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.
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnarodustatPatients are administered with enarodustat with dosage adjusted according to hemoglobin levels to achieve and maintain hemoglobin target over 96 weeks. | Drug | high-hemoglobin target group, low-hemoglobin target group |
Primary outcome
Improvement of quality of life
Time frame: At week 24
Mean change in 36-Item Short Form Health Survey
Effect on MACE+ events
Time frame: During 96 weeks
First occurence of major adverse cardiovascular + event (MACE+; all-cause mortality, myocardial infarction, stroke, and congestive heart failure requiring hospitalization) .
6 secondary outcomes
Effect on blood transfusions
Time frame: During 96 weeks
Effect on thromboembolic events
Time frame: During 96 weeks
Effect on MACE events
Time frame: During 96 weeks
Effect on cardiovascular death
Time frame: During 96 weeks
Effect on renal events
Time frame: During 96 weeks
Effect on eGFR
Time frame: At weeks 24, 48, 72, and 96
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaoqiang Ding principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enarodustat in people with Chronic Kidney Disease Associated Anemia, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoqiang Ding (008613816209067, ding.xiaoqiang@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of quality of life (time frame: At week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.