Clinical Trial Search

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

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

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

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

Primary: Change From Pre-dose Average in Hemoglobin (Hgb) Level to The Mid-study Average — 10.43; 10.55; 10.52; 0.00 Grams per deciliter (g/dL)

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

Primary: Observed Maximum Concentration (Cmax) — 1.022; 2.40; 3.66; 3.97 ug/mL

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: Percent of Subjects Whose Hemoglobin (Hgb) Decreases by a Total of 1.0 Grams/ Deciliter (g/dL) (or More) From Baseline on Each of Two Successive Measurements. — 5; 6; 5…

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

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 in Hb Concentration g/dL Between Baseline and the Efficacy Evaluation Period — 1.75 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…

Primary: Maximum Change From Baseline in Hb During Weeks 3-13 — 8.1; 8.5; 8.4; 8.7 grams/deciliter (g/dL) — p=0.0757

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

Primary: Change in Amount of Epogen Required — -16,572 unit/ml

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

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

Primary: Mean Change in Hemoglobin Between Baseline and the Evaluation Period — 11.20; 11.21; 11.13; 11.05 g/dL

Primary: Change From Baseline in Mean Hb Concentration at Week 20 — 8.820; 1.440 Grams per deciliter (gm/dL) — p=<0.0001

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

Primary: US (FDA) Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Week 28 to Week 52), Regardless of Rescue Therapy (ITT Population)…

Primary: Percentage of Participants Maintaining Mean Hemoglobin Concentration Within +/- 1 g/dL of Their Reference Hb and Between 10.5 and 12.5 g/dL During Efficacy Evaluation…

Primary: Mean Change in Hemoglobin Between Baseline and the Evaluation Period — 11.30; 11.32; 11.06; 11.25 g/dL

Primary: Change in Leucine Disposal Rate (LDR) — -0.011; 0.005; 0.001 mg/kg/min — p=0.37

Primary: Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range…

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