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

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

Primary: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration — 0; 1 Participants

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

Primary: Sit to Stand to Sit Speed: Time Taken to Sit to Stand to Sit 10 Times — 23.8; 22.9 seconds

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

Primary: Absolute Change From Baseline in Hemoglobin (Hgb) to End of Treatment (Week 6) — 9.46; 9.93; 9.86; 9.67 Grams per deciliter (g/dL) — p=<0.0001

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

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

Primary: Percentage of Participants Achieving a Successful Hemoglobin Response — 54.9; 10.3 Percentage of participants — 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: Incidence of Treatment-emergent Serious Adverse Events (SAE's) — 11; 36 participants

Primary: Mortality — 0; 0 percentage of mortality

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: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) — 2; 2; 1; 0 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: Change to Myocardial Glucose Uptake as Measured by Fluoro-deoxy-D-glucose (FDG) Positron Emission Tomography (PET) Scan From Pre-treatment Compared to 6 Months After…

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

Primary: Qualitative Survey Assessmentof Perceived Usefulness of the Med-alert Device. — 1 Likert scale

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

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

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

Primary: Phosphocreatine (PCR) Recovery Time After Knee Extension Assessed by 31 Phosphorus Magnetic Resonance Spectroscopy (31P-MRS) — 60.59; 62.66 seconds

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