Anemia
Conditions
Interventions
experimental group:Enarodustat
control group:Sustained-release ferrous succinate tablets
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
60 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age between 60 and 80 years (inclusive). 2.Meets the diagnostic criteria for chronic kidney disease (CKD) stage 3-4 (15 = estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m²), and is diagnosed with renal anemia. 3.Hemoglobin (Hb) level during the screening period of 90 = Hb < 110 g/L. 4. Iron-restricted erythropoiesis is defined as: serum ferritin (SF) between 100 µg/L and 500 µg/L, with transferrin saturation (TSAT) = 20%. 5.Serum folate and vitamin B12 levels within the normal range. 6.Voluntary provision of written informed consent prior to study initiation.
Exclusion criteria
Exclusion criteria: 1.Abnormal bone marrow hematopoiesis: such as myelodysplastic syndromes (MDS), aplastic anemia, leukemia, etc. 2.Inherited or acquired hemoglobin disorders: such as thalassemia, sickle cell anemia. 3.Hemolytic anemia: including autoimmune, drug-induced, mechanical, and other causes of hemolysis. 4.Acute or chronic blood loss anemia: e.g., active gastrointestinal bleeding with blood loss sufficient to explain the degree of anemia. 5.Tumor-related anemia: history of malignant tumor within the past 5 years, excluding cured malignancies such as basal cell carcinoma of the skin. 6.Uncontrolled severe hypertension: systolic blood pressure >160 mmHg or diastolic >100 mmHg despite antihypertensive therapy. 7.Recent major cardiovascular events: occurrence of myocardial infarction, unstable angina, stroke, deep vein thrombosis, or pulmonary embolism within 3 months prior to screening. 8.Severe hepatic dysfunction: Child-Pugh class C, or ALT/AST > 3× upper limit of normal (ULN). 9.Active infection: acute or chronic infection requiring systemic antimicrobial therapy (e.g., active tuberculosis). 10.Severe inflammatory conditions: anemia caused by active inflammatory diseases such as rheumatoid arthritis or systemic lupus erythematosus. 11.iPTH > 800 pg/mL. 12.Other serious diseases (excluding renal dysfunction) that may significantly affect survival or interfere with study assessments. 13.Expected need for dialysis or kidney transplantation within 2 months. 14.Use of immunosuppressive agents (e.g., high-dose steroids, cyclosporine, tacrolimus, triptolide) or chemotherapeutic drugs within 8 weeks prior to screening. 15.Intravenous iron therapy within 1 month prior to screening. 16.Use of ESA or HIF-PHI within 4 weeks prior to screening. 17.History of polycystic kidney disease. 18.Allergy or drug intolerance: known allergy to oral iron, enarodustat, or any excipient; or previous intolerance to oral iron due to gastrointestinal side effects. 19.Poor compliance: patient judged by investigator unable to follow all study procedures (e.g., taking medications on time, attending follow-up visits); history of alcoholism, substance abuse, or psychiatric disorder potentially affecting compliance. 20.Participation in other clinical trials: any interventional clinical study within 3 months prior to screening. 21.Any condition that, in the investigator’s judgment, may pose safety risks, confound efficacy or safety evaluation, or interfere with study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in hemoglobin level; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of gastrointestinal symptoms;Incidence of thromboembolic events;Change in serum hepcidin level;Incidence of hyperkalemia;Incidence of hypertension;Changes in gut microbiota composition and metabolomic profiles;Change in serum ferritin level;Change in Serum iron level;Change in serum transferrin saturation; | — |
Countries
China
Contacts
Public ContactChen Limeng
Peking Union Medical College Hospital
Outcome results
None listed