Trial · NCT03029208
Outcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in Hemoglobin (Hgb) During Evaluation Period (Week 28 to Week 52) | Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52) | Intent-to-Treat (ITT) Population comprised all randomized participants (who received a treatment randomization number). | Grams per deciliter | LEAST_SQUARES_MEAN |
| SECONDARY | Average Monthly Intravenous Iron Dose (Milligrams) From Baseline to Week 52 | Baseline (Day 1) to Week 52 | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Milligram | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Blood Pressure (MAP) at Week 52 | Baseline (Day 1) and Week 52 | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Millimeter of mercury | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in SBP, DBP, MAP at End of Treatment | Baseline (Day 1) and end of treatment (last on-treatment value until Week 52) | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Millimeter of mercury | LEAST_SQUARES_MEAN |
| SECONDARY | Blood Pressure (BP) Exacerbation Events Rate Per 100 Participant Years | Up to Week 52 | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Events per 100 participant year | NUMBER |
| SECONDARY | Number of Participants With at Least One Blood Pressure Exacerbation Event During Study | Up to Week 52 | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Post-randomization Hgb at Week 52 | Baseline (Day 1) and Week 52 | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Grams per deciliter | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Hgb Responders (Hgb in the Analysis Range of 10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52) | Weeks 28 to 52 | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Time for Which Hgb Was Within the Analysis Range (10 to 11.5 g/dL) During Evaluation Period (Week 28 to Week 52): Non-inferiority Analysis | Weeks 28 to 52 | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Percentage of days | MEDIAN |
| SECONDARY | Percentage of Time for Which Hgb Was Within the Analysis Range (10 to 11.5 g/dL) During Evaluation Period (Week 28 to Week 52): Superiority Analysis | Weeks 28 to 52 | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Percentage of days | MEDIAN |
| SECONDARY | Number of Participants Permanently Stopping Randomized Treatment Due to Meeting Rescue Criteria | Up to Week 52 | ITT Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Physical Component Score (PCS) Using Short Form (SF)-36 Health-related Quality of Life (HRQoL) Questionnaire at Weeks 8, 12, 28, 52 | Baseline (Day 1), Weeks 8, 12, 28 and 52 | ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mental Component Score (MCS) Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52 | Baseline (Day 1), Weeks 8, 12, 28 and 52 | ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52 | Baseline (Day 1), Weeks 8, 12, 28 and 52 | ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Vitality Scores Using SF-36 HRQoL Questionnaire at Weeks 28, 52 | Baseline (Day 1), Weeks 28 and 52 | ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Physical Functioning Domain Scores Using SF-36 HRQoL Questionnaire at Weeks 28, 52 | Baseline (Day 1), Weeks 28 and 52 | ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Health Utility EuroQol 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire Score at Week 52 | Baseline (Day 1) and Week 52 | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in EQ Visual Analogue Scale (EQ-VAS) at Week 52 | Baseline (Day 1) and Week 52 | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Week 52 | Baseline (Day 1) and Week 52 | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Patient Global Impression of Severity (PGI-S) | Baseline (Day 1), Weeks 8, 12, 28 and 52 | ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). | Scores on a scale | LEAST_SQUARES_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/NCT03029208/outcomes