Trial · NCT01750190
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | United States (US FDA) Submission: Mean Change From Baseline in Hb (g/dL) Over Weeks 28 to 52 Regardless of Rescue Therapy | Baseline (Day 1, Week 0), Weeks 28 to 52 | ITT Population included all randomized/enrolled participants. | g/dL | MEAN |
| PRIMARY | Ex-US Submission: Number (%) of Participants Who Achieved a Hb Response During the First 24-Weeks of Treatment Censoring for Rescue Therapy | Baseline up to Week 24 | FAS Population included of all randomized/enrolled participants who received at least 1 dose of study drug and had baseline and at least 1 postdose Hb assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change From Baseline in Hb Averaged Over Weeks 28 to 36 With Censoring for Rescue Therapy | Baseline (Day 1, Week 0), Weeks 28 to 36 | FAS Population included all randomized/enrolled participants who received at least 1 dose of study drug and had baseline and at least 1 postdose Hb assessment. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint. | g/dL | MEAN |
| SECONDARY | Mean Change From Baseline in Hb Averaged Over Weeks 28 to 52 Regardless of Rescue Therapy in Participants With Baseline C-Reactive Protein (CRP) >Upper Limit of Normal (ULN) | Baseline (Day 1, Week 0), Weeks 28 to 52 | FAS Population included all randomized/enrolled participants who received at least 1 dose of study drug and had baseline and at least 1 postdose Hb assessment. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | g/dL | MEAN |
| SECONDARY | Number (%) of Participants With Hb ≥10 g/dL Averaged Over Weeks 28 to 36 With Censoring for Rescue Therapy | Weeks 28 to 36 | FAS Population consisted of all randomized/enrolled participants who received at least 1 dose of study drug and had baseline and at least 1 postdose Hb assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol Averaged Over Weeks 12 to 28 | Baseline (Day 1, Week 0), Weeks 12 to 28 | FAS Population included all randomized/enrolled participants who received at least 1 dose of study drug and had baseline and at least 1 postdose Hb assessment. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint. | mg/dL | MEAN |
| SECONDARY | Rate of Change in eGFR From Baseline up to 12 Months (Linear Random Coefficient Model With Observed Data) | Baseline, Month 12 | FAS Population included all randomized/enrolled participants who received at least 1 dose of study drug and had baseline and at least 1 postdose Hb assessment. | ml/min/1.73 m^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Who Received Blood/RBC Transfusion in the First 52 Weeks of Treatment | Baseline up to Week 52 | FAS Population included all randomized/enrolled participants who received at least 1 dose of study drug and had baseline and at least 1 postdose Hb assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number (%) of Participants Who Received Rescue Therapy in the First 24 Weeks and in the First 52 Weeks of Treatment | Baseline (Day 1, Week 0) up to Week 24 and up to Week 52 | FAS Population included all randomized/enrolled participants who received at least 1 dose of study drug and had baseline and at least 1 postdose Hb assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 12 to 28 | Baseline (Day 1, Week 0), Weeks 12 to 28 | FAS Population included all randomized/enrolled participants who received at least 1 dose of study drug and had baseline and at least 1 postdose Hb assessment. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified timepoint. | scores on a scale | MEAN |
| SECONDARY | Number (%) of Participants Who Experienced Exacerbation of Hypertension | Baseline up to Week 52 | FAS Population included all randomized/enrolled participants who received at least 1 dose of study drug and had baseline and at least 1 postdose Hb assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change From Baseline in Mean Arterial Pressure (MAP) Averaged Over Weeks 20 to 28 | Baseline, Weeks 20 to 28 | FAS Population included all randomized/enrolled participants who received at least 1 dose of study drug and had baseline and at least 1 postdose Hb assessment. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint. | mmHg | 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/NCT01750190/outcomes