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New treatment option for Chronic Kidney Disease Associated Anemia
Official title Correction of Anemia With Enarodustat in Non-dialysis Dependent Chronic Kidney Disease
ClinicalTrials.gov ID: NCT06725810
What this study is testing
What is Enarodustat?
Enarodustat is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic kidney disease associated anemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Time commitment: about 96 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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: 1)Hemoglobin level of 6 - 10 g/dL for those who have not received ESA or HIF-PHI treatment within 6 weeks at screening...
You likely can't join if
- Uncontrolled hypertension identified as systolic blood pressure \>160mmHg or diastolic blood pressure \>100mmHg after 4 weeks of regular and adequate...
- 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...
- Anemia due to other reasons except CKD including systemic hematological disorders (such as myelodysplastic syndrome, aplastic anemia, etc.)...
- 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...
See the full eligibility criteria
- 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...
- 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.);
- 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 treatment clinical trial;
- Other reasons determined by the investigator not suitable for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 96 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.