Trial · NCT03409107
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change in Hemoglobin From Baseline and Over the Evaluation Period (Mean Over Week 24 and 28) | Baseline (Day 1) and Week 24 to Week 28 | Intent-to-Treat (ITT) Population comprised all randomized participants regardless of whether they took study drug. | Grams per deciliter | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Hemoglobin Increase of >=1.0 Grams Per Deciliter From Baseline to Evaluation Period | Baseline (Day 1) and Week 24 to Week 28 | Intent-to-Treat population. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Short Form-36 (SF-36) Questionnaire Vitality Domain Score by Traditional Scoring at Week 28 | Baseline (Day 1) and Week 28 | Intent-to-Treat Population. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Hgb Response (Hgb in the 11-12 Grams/Deciliter Range) During Evaluation Period (Week 24 to Week 28 Inclusive) | Week 24 to Week 28 | Intent-to-Treat Population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Time With Hgb Within the Target Range (11-12 Grams Per Deciliter) During Evaluation Period (Week 24 to Week 28 Inclusive) (Hodges-Lehmann Estimate) | Week 24 to Week 28 | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed. | Percentage of days | MEDIAN |
| SECONDARY | Percentage of Time With Hgb Within the Target Range (11-12 Grams Per Deciliter) During Evaluation Period (Week 24 to Week 28 Inclusive) (Mann-Whitney Estimate) | Week 24 to Week 28 | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed. | Percentage of days | MEDIAN |
| SECONDARY | Change From Baseline in Post-randomization Hgb at Week 28 | Baseline (Day 1) and Week 28 | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed. | Grams per deciliter | LEAST_SQUARES_MEAN |
| SECONDARY | Rate of Participants Permanently Stopping Randomized Treatment Due to Meeting Rescue Criteria | Up to Week 28 | Intent-to-Treat Population. | Events per 100 person year | NUMBER |
| SECONDARY | Change From Baseline by Domain and Single Item Scores on the Chronic Kidney Disease -Anemia Questionnaire (CKD-AQ) Symptom Questionnaire | Baseline (Day 1) and Week 28 | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed. | Scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Patient Global Impression of Severity (PGI-S) | Baseline (Day 1) and Week 28 | Intent-to-Treat 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 the SF-36 Physical Functioning Domain | Baseline (Day 1) and Week 28 | Intent-to-Treat 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 of the SF-36 Individual Items in the Vitality Domain | Baseline (Day 1) and Week 28 | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Currently Employed as Per Work Productivity and Activity Impairment Questionnaire: Anemic Symptoms Clinical Practice Version (WPAI-ANS-CPV) | Week 8, Week 12 and Week 28 | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in category titles). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in WPAI-ANS-CPV: Percent Time Missed From Work | Baseline (Day 1), Week 8, Week 12 and Week 28 | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in category titles). | Percentage of time | MEAN |
| SECONDARY | Change From Baseline in WPAI-ANS-CPV: Mean Hours Missed From Work in the Past 7 Days | Baseline (Day 1), Week 8, Week 12 and Week 28 | Intent-to-Treat Population. Only those participants with data available at indicated time points are presented (presented by n=X in category titles). | Percentage of hours | MEAN |
| SECONDARY | Change From Baseline in WPAI: Percent Impairment at Work | Baseline (Day 1), Week 8, Week 12 and Week 28 | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in category titles). | Percentage of impairment | MEAN |
| SECONDARY | Change From Baseline in WPAI: Percent Overall Work Impairment | Baseline (Day 1), Week 8, Week 12 and Week 28 | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in category titles). | Percentage of impairment | MEAN |
| SECONDARY | Change From Baseline in WPAI: Percent Regular Daily Activity Impairment | Baseline (Day 1), Week 8, Week 12 and Week 28 | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in category titles). | Percentage of impairment | MEAN |
| SECONDARY | Change From Baseline in EuroQol 5 Dimension 5 Level Health Utility Index (EQ-5D-5L) Utility Score | Baseline (Day 1) and Week 28 | Intent-to-Treat Population. Only those participants with data available at indicated time points are presented. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in EuroQol Visual Analogue Scale (EQ-VAS) Score | Baseline (Day 1) and Week 28 | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed. | 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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03409107/outcomes