Treatment of renal anemia in non-dialysis adult patients with stage 3–4 chronic kidney disease Urological and Genital Diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 21 to 69 years old, no gender limitation 2. Diagnosed with stage 3–4 chronic kidney disease with estimated glomerular filtration rate of 15–59 mL/min/1.73 m² and not receiving dialysis 3. Meet the diagnostic criteria for renal anemia: hemoglobin level less than 120 g/L for males and less than 110 g/L for females 4. No recombinant human erythropoietin or intravenous iron agents administered within four weeks before enrollment 5. Serum ferritin higher than 100 ng/mL and transferrin saturation above 20% to rule out absolute iron deficiency 6. Voluntarily participate and sign written informed consent
Exclusion criteria
Exclusion criteria: 1. Anemia caused by gastrointestinal hemorrhage, hemolysis and hematological diseases including aplastic anemia, myelodysplastic syndrome and thalassemia 2. Patients complicated with severe infection, hepatic insufficiency with alanine transaminase/aspartate transaminase levels exceeding three times the upper limit of normal values, malignant tumors or active autoimmune diseases 3. Individuals with allergies to ingredients of investigational drugs such as ferrous succinate, erythropoietin and components of traditional Chinese herbal prescriptions 4. Pregnant or lactating women 5. Participants enrolled in other ongoing clinical trials 6. Subjects with poor treatment compliance or those deemed ineligible for enrolment by researchers for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in hemoglobin (Hb) level measured using fasting venous blood hemoglobin concentration via Sysmex XN-9000 automatic hematology analyzer, unit: g/L at baseline (week 0), week 8;Change in reticulocyte hemoglobin content (CHr) measured using reticulocyte mean fluorescence intensity by Sysmex XN flow cytometry and convert to CHr value, unit: pg at baseline (week 0), week8;Change in soluble transferrin receptor (sTfR) measured using immunoturbidimetry assay on Roche Cobas c702 analyzer with matched reagents, unit: mg/L at baseline (week 0), week 8 | — |
Countries
China