Using enarodustat to correct anemia in adults with non-dialysis chronic kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, open-label, randomized multicenter trial in China that will enroll about 1,670 adults with non-dialysis chronic kidney disease (stages 2–5) and anemia. Participants are randomized 1:1 to an enarodustat dosing strategy targeting either hemoglobin 13 g/dL or hemoglobin 11 g/dL, with dose adjustments to maintain the assigned target over 96 weeks. The main clinical outcome is change in the 36-Item Short Form Health Survey (SF-36) at week 24, and the key safety outcome is time to major adverse cardiovascular events (MACE+) over 96 weeks. The initial enarodustat dose is 4 mg once daily for all patients, with subsequent titration per protocol and hemoglobin target group.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged 18-75 years at the time of consent to participate;
2. Body weight ranged from 45 to 100 kg;
3. Diagnosed with CKD stages 2-5 (10 ≤ eGFR \< 90 mL/min/1.73m2) and were not dialysis dependent;
4. 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.

Exclusion Criteria:

1. 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;
2. 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;
3. 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;
4. History of autoimmune diseases which could result in anemia such as systemic lupus erythematosus and ANCA vasculitis;
5. History of active bleeding within 4 weeks prior to screening;
6. 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;
7. Severe heart failure (NYHA class IV) at screening;
8. History of blood transfusion within 2 months prior to screening;
9. History of usage of immunosuppressants or other immune therapies within 6 months prior to screening;
10. Patients who are estimated to require dialysis, kidney transplantation, or major surgery within 6 months;
11. 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;
12. Receiving ESA combined with roxadustat treatment at screening;
13. History of proliferative retinopathy or diabetic retinopathy requiring ophthalmological treatment;
14. Severe hyperparathyroidism (iPTH ≥ 500 pg/mL);
15. Severe active infections (such as active tuberculosis, fungal infections, etc.);
16. Patients who are bedridden or have difficulty walking, or have a history of atrial fibrillation or deep vein thrombosis of the lower limbs;
17. History of active tumors;
18. Female patients who are pregnant or breastfeeding, or non-childbearing women who do not agree to effective contraception;
19. 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;
20. Patients who are currently participating in any other interventional clinical trial;
21. Other reasons determined by the investigator not suitable for participation in the study.

Where it's running

• Zhongshan hospital, Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Xiaoqiang Ding — Fudan University
• Study coordinator: Xiaoqiang Ding
• Email: ding.xiaoqiang@zs-hospital.sh.cn
• Phone: 008613816209067

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Evaluating the safety of Desidustat for treating anemia in chronic kidney disease patients

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• Switching dialysis patients on HIF-PHI to long‑acting pegmolesatide for renal anemia

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• Switching to pegmolesatide for anemia in people on dialysis

  This 24-week test will try whether switching dialysis patients whose anemia isn't at goal from rHuEPO to pegmolesatide alone or combined with roxadustat keeps or raises hemoglobin better than continuing rHuEPO.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.