Clinical Trial Search

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

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

Primary: Hemoglobin Concentrations — 11.5; 12.2 g/dL — p=0.02

Primary: Percent Hb 10-12 g/dL — 61.9; 72.5 Percent

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

Primary: Feasibility of Enrolling Patients in the Trial — 85 participants

Primary: Change in Left Ventricular End-diastolic Volume — -6; -4 mL

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

Primary: Hemoglobin Levels at 12-weeks. Marginal Means (95% CI). — 123; 116; 121; 116 g/L — p=<0.05

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

Primary: Percentage of Participants Maintaining Average Hemoglobin Concentration Within the Target Range During the Efficacy Evaluable Period (EEP) — 53.9 percentage of…

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

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: Change in Serum Hepcidin With Vitamin D Intervention for Children With Chronic Kidney Disease — 48.2; 75.4 ng/ml

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: Incidence of Treatment-emergent Serious Adverse Events (SAE's) — 11; 36 participants

Primary: Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP)…

Primary: RBC Transfusion — 47; 55 participants

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

Primary: Haemoglobin Level — 88.3; 89.2; 88.4; 89.6 g/L — p=<0.05

Primary: Percentage of Participants Who Maintained Their Mean Hemoglobin Concentration Within +/- 1.0 Gram/Deciliter of Their Reference Hemoglobin Concentration and Between 10.0…

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 Maintaining Their Mean Hb Concentration Within Plus/Minus (±) 1 Grams Per Deciliter (g/dL) of the Reference Range and Between 10.0 and 12.0…

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

Primary: Percentage of Participants Maintaining Mean Hemoglobin Levels Within the Target Range During the Last 4 Weeks of the Treatment Period (Weeks 8 to 12) — 57.89 Percentage…

Primary: Change From Baseline in Hemoglobin Concentration (gm/dl) — 0.12; 0.09 gm/dl — p=0.81

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

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