To evaluate the Effectiveness and Safety of Daprodustat Tablet in Patients with Anemia due to chronic kidney disease not requiring Dialysis

INTERVENTION: Intervention1: Daprodustat 1 mg, 2 mg, 4 mg, 6 mg: Tablets once daily for 24 weeks Control Intervention1: Epoetin Alfa 4000 IU, 10000 IU Injection: 50 Units per kg 3 times weekly subcutaneously for 24 weeks CONDITION: Health Condition 1: D631‐ Anemia in chronic kidney disease PRIMARY OUTCOME: 1 Change from baseline in hemoglobin levelTimepoint: 1 Change from baseline in hemoglobin level SECONDARY OUTCOME: 1. Average monthly IV iron requirementTimepoint: [Time frame: Weeks 4, 8, 12, 16, 20 and 24] 2. Change from baseline in hemoglobin levelTimepoint: [Time frame: Baseline, Weeks 4, 8, 12, 16 and 20] 3. Change from baseline in SBPTimepoint: [Time frame: Baseline, Weeks 4, 8, 12, 16, 20 and 24] 4. Change from baseline in DBPTimepoint: [Time frame: Baseline, Weeks 4, 8, 12, 16, 20 and 24] 5. Change from baseline in Short Form Health Survey scoreTimepoint: [Time frame: Baseline, Weeks 12 and 24] INCLUSION CRITERIA: 1 Patients of either gender with age between 18 to 75 years both inclusive and willing to provide written informed consent 2 Patients with a diagnosis of chronic kidney disease Stage 3 to Stage 5 both inclusive and not requiring dialysis prior to Screening 3 Patients with Haemoglobin level 8 gdl to 10 gdl both inclusive at Screening and Randomization Visit 2 4 Patient should not be receiving any erythrocyte stimulating agent within 8 weeks prior to Screening 5 Women of childbearing potential must have a negative urine pregnancy test prior to Screening and Randomization and agree to use highly effective methods of contraception to prevent pregnancy from study entry till end of study 6 Male patients must have had a successful vasectomy or they and their female partners must meet the criteria above not of childbearing potential or practicing highly effective contraception throughout the study period

Epistemonikos ID: 9f752f101f4e12f4ff8eb12a62ae90206e12957f
First added on: Oct 08, 2026