Clinical Trial Search

Primary: % Patients Achieving Target Hemoglobin Levels — 42.5; 35.3 percentage of participants

Primary: Percentage of Participants With a Hemoglobin (Hb) Response to Treatment at Two Consecutive Visits During the First 24 Weeks of Treatment Without Rescue Therapy Prior to…

Primary: Percentage of Participants by ESA Types at Baseline — 51.5; 17.3; 10.7; 20.4 percentage of participants

Primary: Time to First Occurrence of Adjudicated Major Adverse Cardiovascular Event (MACE) During Cardiovascular (CV) Events Follow-up Time Period (Non-inferiority Analysis)…

Primary: Mean Change in Hemoglobin Between Baseline and the Evaluation Period — 10.02; 10.03; 10.03; 11.55 g/dL

Primary: Change in Hemoglobin (Hgb) — 0.6; 0.2 g/dL

Primary: Time to First Occurrence of Adjudicated Major Adverse Cardiovascular Event (MACE) During Cardiovascular (CV) Events Follow-up Time Period: Non-inferiority Analysis…

Primary: Mean Change in Hemoglobin Between Baseline and the Evaluation Period — 10.05; 9.95; 10.05; 11.47 g/dL

Primary: Number (%) of Participants With an Hb Response by Week 17 — 19; 24; 21; 23 Participants

Primary: Percentage of Fractional Oral Iron Absorption Following Treatment With Daprodustat and rhEPO — 20.64; 20.62 Percentage (%) of iron absorbed — p=0.9971

Primary: Mean Change From Baseline in Hemoglobin (Hgb) During Evaluation Period (Week 28 to Week 52) — 1.02; 1.12 Grams per deciliter

Primary: Number of Subjects Achieving an Increase in Hemoglobin ≥1g/dL — 87; 35 participants

Primary: Mean Change From Baseline in Hemoglobin (Hgb) on Day 29 — 9.91; 0.63 Grams per decilitre (g/dL) — p=0.0020

Primary: Patients With an Increase in Hemoglobin >= 1gm/dL. — 35; 23 participants

Primary: Mean Change in Hemoglobin From Baseline and Over the Evaluation Period (Mean Over Week 24 and 28) — 0.19; 1.58 Grams per deciliter — p=<0.0001

Primary: Percentage of Participants With Both Hemoglobin Values of the Evaluation Phase in the Range of 11-12 Grams Per Deciliter (g/dL) — 10.67 percentage of participants

Primary: Baseline Hemoglobin Concentration — 10.3; 10.4 g/dL

Primary: Percentage of Participants With Hemoglobin (Hb) Response — 94.12; 93.51 percentage of participants — p=<0.0001

Primary: United States (US FDA) Submission: Mean Change From Baseline in Hb (g/dL) Over Weeks 28 to 52 Regardless of Rescue Therapy — 9.10; 9.09; 2.00; 0.16 g/dL — p=<0.0001

Primary: Hemoglobin Concentration at 6 Months — 117; 113 g/L

Primary: Mean Height of Participants at Baseline (Week 0) — 163.15 cm

Primary: Haemoglobin Increase of Greater or Equal to 5g/l Following Receipt of Treatment — 53; 61 Participants

Primary: Change in Hemoglobin (Hb) Concentration From Baseline to Week 4. — 0.57; 0.35 g/dL

Primary: Percentage of Participants With a Hb Response to Treatment at Two Consecutive Visits During the First 24 Weeks of Treatment Without Rescue Therapy — 89.5; 78.0…

Primary: Change From Baseline (BL) to the Average Hemoglobin (Hb) in Weeks 28-36 Without Rescue Therapy [EU (EMA)] — 0.428; 0.193 g/dL — p=<0.001

Primary: Mean Change in Hemoglobin Between Baseline and the Evaluation Period — 9.34; 9.20; 9.07; 11.45 g/dL

Primary: Median Time to First Cardiovascular Event — NA; NA days — p=0.2036

Primary: Percentage of Participants in Receipt of 1 or More RBC Transfusions — 24.40; 24.14 Percentage of Participants

Primary: Mean Hb Level of Week 20 and Week 24 — 11.66; 11.93 g/dL

Primary: Percentage of Participants Who Experienced Increase and Maintain Hemoglobin Levels (Two Consecutive Values) Greater Than or Equal to the Lower Limit of the Target Range…