Trial · NCT02021318
Outcomes61
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 61
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With a Hb Response to Treatment at Two Consecutive Visits During the First 24 Weeks of Treatment Without Rescue Therapy | Baseline to week 24 | The analysis population was the Per Protocol Set (PPS) which consisted of all Full Analysis Set (FAS) participants who did not meet any of exclusion criteria from the PPS. The FAS consisted of all randomized participants who received at least one dose of study drug and had at least one post-dose valid Hb assessment. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in Hb to the Average Hb of Weeks 28 to 36 Without Rescue Therapy Within 6 Weeks Prior to and During This 8-Week Evaluation Period | Baseline and weeks 28 to 36 | The analysis population was the PPS, with participants who had available data. | g/dL | MEAN |
| SECONDARY | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) to the Average LDL-C of Weeks 12 to 28 | Baseline and weeks 12 to 28 | The analysis population was the FAS, with participants who had available data. | Millimoles per liter (mmol/L) | MEAN |
| SECONDARY | Time to First Intravenous Iron Use | Weeks 6, 12, 18, 24, 30 and 36 | The analysis population was the FAS. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Short Form-36 (SF-36) Physical Functioning (PF) Sub-Score to the Average PF Sub Score in Weeks 12 to 28 | Baseline and weeks 12 to 28 | The analysis population was the PPS, with participants who had available data. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in SF-36 Vitality (VT) Sub-Score to the Average VT Sub-Score in Weeks 12 to 28 | Baseline and weeks 12 to 28 | The analysis population was the PPS, with participants who had available data. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Mean Arterial Pressure (MAP) to the Average MAP Value in Weeks 20 to 28: Per Protocol Set | Baseline and weeks 20 to 28 | The analysis population was the PPS, with participants who had available data. | Millimeters of mercury (mmHg) | MEAN |
| SECONDARY | Time to First Occurrence of Hypertension During Weeks 1 to 36: Per Protocol Set | Weeks 1 to 36 | The analysis population was the PPS. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in MAP to the Average MAP Value in Weeks 20 to 28: Full Analysis Set | Baseline and weeks 20 to 28 | The analysis population was the FAS, with participants who had available data. | mmHg | MEAN |
| SECONDARY | Time to First Occurrence of Hypertension During Weeks 1 to 36: Full Analysis Set | Weeks 1 to 36 | The analysis population was the FAS. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in Hb to the Average Hb Value of Weeks 28 to 52 Regardless of Rescue Therapy | Baseline and weeks 28 to 52 | The analysis population was the FAS, with participants who had available data. | g/dL | MEAN |
| SECONDARY | Time to First Hb Response During First 24 Weeks of Treatment Regardless of Administration of Rescue Therapy | Weeks 1 to 24 | The analysis population was the FAS. | Percentage of Participants | NUMBER |
| SECONDARY | Time to First Hb Response During First 24 Weeks of Treatment Without Rescue Therapy | Weeks 1 to 24 | The analysis population was the FAS. | Percentage of participants | NUMBER |
| SECONDARY | Hb Level Averaged Over Weeks 28 to 36, 44 to 52, 72 to 80 and 96 to 104 Without Rescue Therapy | Weeks 28 to 36, 44 to 52, 72 to 80 and 96 to 104 | The analysis population was the FAS. | g/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Hb to Each Postdosing Time Point Regardless Use of Rescue Therapy | Baseline 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 and 104 | The analysis population was the FAS. | g/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Hb to Average Hb Value of Weeks 28 to 36, 44 to 52, 72 to 80, 96 to 104 Regardless of Use of Rescue Therapy | Baseline and weeks 28 to 36, 44 to 52, 72 to 80 and 96 to 104 | The analysis population was the FAS. | g/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Hb Values >=10 g/dL and Within 10.0 to 12.0 g/dL in Weeks 28 to 36, 44 to 52, and 96 to 104 Without Use of Rescue Therapy | Weeks 28 to 36, 44 to 52 and 96 to 104 | The analysis population was the FAS. | Percentage of Hb values | MEAN |
| SECONDARY | Time to First Hb Rate of Rise > 2 g/dL Within 4 Weeks | Year 0.5, 1, 1.5 and 2 | The analysis population was the FAS. | Percentage of participants | NUMBER |
| SECONDARY | Number of Hospitalizations | Baseline to EOT (up to week 104) | The analysis population was the FAS. | Hospitalizations | MEAN |
| SECONDARY | Number of Days of Hospitalization Per Year | Baseline to EOT (up to week 104) | The analysis population was the FAS. | Days per year | 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.
For software
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GET https://conductscience.org/api/trials/v1/NCT02021318/outcomes