Clinical Trial Search

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

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

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

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

Primary: Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) — 96; 58; 57; 93 participants — p=<0.0001

Primary: Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36) — 1.26; 1.58 Grams per deciliter (g/dL)

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

Primary: Phosphorus Levels — 5.3; 5.6; 5.4; 6 mg/dL

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 — 11.20; 11.21; 11.13; 11.05 g/dL

Primary: Mean Change in Hemoglobin Between Baseline and the Evaluation Period — 9.34; 9.20; 9.07; 11.45 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 From Baseline to the Highest Hemoglobin up to Day 71 — 1.3; .7 g/dL

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

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

Primary: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) — 2; 2; 1; 0 Participants

Primary: Mean Hemoglobin Throughout the Trial and Mean Hemoglobin Change From Baseline Throughout the Trial. — 11.10; 11.34; 11.42; 11.19 g/dL

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

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

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

Primary: Mean Change From Baseline in Hemoglobin Levels Over the Evaluation Period (Week 28 to Week 52) — -0.04; 0.02 Grams per deciliter (g/dL)

Primary: Percentage of Participants Maintaining Average Hemoglobin (Hb) Concentration Within the Target Range — 77.1; 88.5; 90.9; 84.3 percentage of participants

Primary: Mean Change in Hb Concentration g/dL Between Baseline and the Efficacy Evaluation Period — 1.75 g/dL

Primary: To Compare the Efficacy of HX575 Hexal AG and ERYPO® Janssen-Cilag. — 0.147; 0.063 g/dL

Primary: Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period — -0.10; 0.01; -0.10 gram per deciliter (g/dL) — p=<0.0001