Trial · NCT01887600
Outcomes53
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 53
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 Hb Response | Baseline to week 24 | The analysis population was the full analysis set (FAS), which consisted of all randomized participants who received at least one dose of study drug and had at least one post-dose Hb assessment. | Percentage of Participants | NUMBER |
| PRIMARY | Hb Change From Baseline (BL) to the Average Hb in Weeks 28-52 Regardless of Rescue Therapy | Baseline and weeks 28 to 52 | The analysis population was All Randomized, and it consisted of all randomized participants with available data at all time points. | g/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Hb Change From BL to the Average Hb in Weeks 28-36 Without Having Received Rescue Therapy Within 6 Weeks Prior to and During 8-Week Evaluation Period | Baseline and weeks 28 to 36 | The analysis population was the full analysis set (FAS), which consisted of all randomized participants who received at least one dose of study drug and had at least one post-dose Hb assessment. | g/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From BL in Low-Density Lipoprotein (LDL) Cholesterol (Regardless of Fasting Status) to the Average LDL Cholesterol of Weeks 12 to 28 | Baseline and weeks 12 to 28 | The analysis population was the FAS, which consisted of all randomized participants who received at least one dose of study drug and had at least one post-dose Hb assessment. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Time to First Use of Rescue Therapy (Composite of Red Blood Cell (RBC) Transfusions, Erythropoiesis-stimulating Agent (ESA) Use, and Intravenous (IV) Iron) | Baseline to week 104 (End of Treatment [EOT]) | The analysis population was the FAS, which consisted of all randomized participants who received at least one dose of study drug and had at least one post-dose Hb assessment. | Percentage of participants | NUMBER |
| SECONDARY | Change From BL in Short Form (SF)-36 Vitality (VT) Sub-score to the Average VT Sub-score of Weeks 12 to 28 | Baseline and weeks 12 to 28 | The analysis population was the FAS, which consisted of all randomized participants who received at least one dose of study drug and had at least one post-dose Hb assessment. | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From BL in SF-36 Physical Functioning (PF) Sub-score to the Average PF Sub-score of Weeks 12 to 28 | Baseline and weeks 12 to 28 | The analysis population was the FAS, which consisted of all randomized participants who received at least one dose of study drug and had at least one post-dose Hb assessment. | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From BL in Mean Arterial Pressure (MAP) to the Average MAP of Weeks 20 to 28 | Baseline and weeks 20 to 28 | The analysis population was the per protocol set (PPS), which consisted of all FAS participants who did not meet any reasons for exclusion from the PPS and had all available data at all time points. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Time to First Occurrence of Hypertension | Baseline and year 0.5, year 1, year 1.5 and year 2 | The analysis population was the PPS, which consisted of all FAS participants who did not meet any reasons for exclusion from the PPS and had all available data at all time points. | Percentage of participants | NUMBER |
| SECONDARY | Rate of Progression of CKD Measured by Annualized Estimated Glomerular Filtration Rate (eGFR) Slope Over Time | Baseline to week 108 | The analysis population was the FAS, which consisted of all randomized participants who received at least one dose of study drug and had at least one post-dose Hb assessment. | ml/min per 1.73 m^2 per year | LEAST_SQUARES_MEAN |
| SECONDARY | Average Level of Hb Over Weeks 28 to 36 Without Use of Rescue Therapy Within 6 Weeks Prior to and During the Evaluation Period | Weeks 28 to 36 | The analysis population was the FAS, which consisted of all randomized participants who received at least one dose of study drug and had at least one post-dose Hb assessment. | g/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Average Level of Hb Over Weeks 44 to 52 Without Use of Rescue Therapy Within 6 Weeks Prior to and During the Evaluation Period | Weeks 44 to 52 | The analysis population was the FAS, which consisted of all randomized participants who received at least one dose of study drug and had at least one post-dose Hb assessment. | g/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Average Level of Hb Over Weeks 96 to 104 Without Use of Rescue Therapy Within 6 Weeks Prior to and During the Evaluation Period | Weeks 96 to 104 | The analysis population was the FAS, which consisted of all randomized participants who received at least one dose of study drug and had at least one post-dose Hb assessment. | g/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Time to Achieve the First Hb Response Without Rescue Therapy, as Defined by Primary Endpoint | Baseline to week 24 | The analysis population was the FAS, which consisted of all randomized participants who received at least one dose of study drug and had at least one post-dose Hb assessment. | Percentage of participants | NUMBER |
| SECONDARY | Hb Change From BL to Each Post-Dosing Time Point | Baseline (day 1) and weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104 | The analysis population was the FAS, which consisted of all randomized participants who received at least one dose of study drug and had at least one post-dose Hb assessment. | g/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Hb Change From BL to the Average Hb Value of Weeks 28-36 Regardless of the Use of Rescue Therapy | Baseline and weeks 28 to 36 | The analysis population was the FAS, which consisted of all randomized participants who received at least one dose of study drug and had at least one post-dose Hb assessment. | g/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Hb Change From BL to the Average Hb Value of Weeks 44-52 Regardless of the Use of Rescue Therapy | Baseline and weeks 44 to 52 | The analysis population was the FAS, which consisted of all randomized participants who received at least one dose of study drug and had at least one post-dose Hb assessment. | g/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Hb Change From BL to the Average Hb Value of Weeks 96-104 Regardless of the Use of Rescue Therapy | Baseline and weeks 96 to 104 | The analysis population was the FAS, which consisted of all randomized participants who received at least one dose of study drug and had at least one post-dose Hb assessment. | g/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Hb Values Within 10.0-12.0 g/dL in Weeks 28-36 Without Use of Rescue Therapy | Baseline and weeks 28 to 36 | The analysis population was the FAS, which consisted of all randomized participants who received at least one dose of study drug and had at least one post-dose Hb assessment. | Percentage of Hb values | MEAN |
| SECONDARY | Percentage of Hb Values Within 10.0-12.0 g/dL in Weeks 44-52 Without Use of Rescue Therapy | Baseline and weeks 44 to 52 | The analysis population was the FAS, which consisted of all randomized participants who received at least one dose of study drug and had at least one post-dose Hb assessment. | Percentage of Hb values | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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