Trial · NCT01587898
Outcomes43
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 43
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Modeled Hgb Change From Baseline Over 4 Weeks of Treatment | Baseline (average of Week -2, -1 and Day 1) and Week 4 | The ITT population comprised of all randomized participants who received at least one dose of study medication, and had a baseline and at least one corresponding on treatment laboratory assessment. Only those participants with data available at the indicated time points were analyzed. | gram per decilitre (g/dL) | MEAN |
| SECONDARY | Model-Adjusted Maximum Hgb Changes Over 4 Weeks | Baseline (average of Week -2 , -1 and Day 1 visits) and 4 weeks | ITT population. | g/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Up to 4 weeks | ITT Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Up to 4 weeks | ITT population. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants Who Reached Hgb Stopping Criteria | Up to Week 4 | ITT Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Hepcidin at Week 2 and Week 4 | Baseline (Pre-dose on Day 1), Week 2 and 4 | ITT Population. Only those participants available at the specified time points were analyzed. | Microgram per Litre (mcg/L) | MEAN |
| SECONDARY | Change From Baseline in Ferritin at Week 2 and Week 4 | Baseline (Day 1 Pre-dose), Week 2 and 4 | ITT Population. Only those participants available at the specified time points were analyzed. | mcg/L | MEAN |
| SECONDARY | Change From Baseline in Transferrin at Week 2 and Week 4 | Baseline (Day 1 Pre-dose), Week 2 and 4 | ITT population. Only those participants available at the specified time points were analyzed. | Grams per litre (G/L) | MEAN |
| SECONDARY | Change From Baseline in Transferrin Saturation at Week 2 and Week 4 | Baseline (Day 1 Pre-dose), Week 2 and 4 | ITT Population. Only those participants available at the specified time points were analyzed. | Percentage of transferrin saturation | MEAN |
| SECONDARY | Change From Baseline in Total Iron Binding Capacity at Week 2 and Week 4 | Baseline (Day 1 Pre-dose), Week 2 and 4 | ITT population. Only those participants available at the specified time points were analyzed. | Micromol per litre (micromol/L) | MEAN |
| SECONDARY | Change From Baseline in Total Iron at Week 2 and Week 4 | Baseline (Day 1 Pre-dose), Week 2 and 4 | ITT Population. Only those participants available at the specified time points were analyzed. | micromol/L | MEAN |
| SECONDARY | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 2 and Week 4 | Baseline (Day 1 Pre-dose), Week 2 and 4 | ITT population. Only those participants available at the specified time points were analyzed | miligram per litre (mg/L) | MEAN |
| SECONDARY | Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks | Baseline (Day 1 pre-dose), Week 1, 2, 3, and 4 | ITT Population. Only those participants available at the specified time points were analyzed. | Ratio | MEAN |
| SECONDARY | Change From Baseline in Erythropoietin at Week 2 and Week 4 | Baseline (Day 1 Pre-dose), Week 2 and 4 | ITT Population. Only those participants available at the specified time points were analyzed. | Units per litre (U/L) | MEAN |
| SECONDARY | Change From Baseline in Red Blood Cells Count Over 4 Weeks | Baseline (Day 1 pre-dose), week 1, 2, 3, 4 | ITT population. Only those participants available at the specified time points were analyzed. | 10^12 cells /L | MEAN |
| SECONDARY | Change From Baseline in Vascular Endothelial Growth Factor (VEGF) at Week 2 and Week 4 | Baseline (Pre-dose), week 2 and 4 | ITT population. Only those participants available at the specified time points were analyzed. | Nanogram per litre (ng/L) | MEAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 6 weeks | The Safety Population comprised of all participants who received at least one dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Discontinuing the Study Treatment Due to AEs | Up to 6 weeks | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | Baseline (Day 1 pre-dose), Week 2, 4, and 6 | Safety Population. Only those participants available at the specified time points were analyzed. | International Units per litre (IU/L) | MEAN |
| SECONDARY | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Baseline (Day 1 pre-dose), Week 2, 4, and 6 | Safety population. Only those participants available at the specified time points were analyzed | G/L | 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/NCT01587898/outcomes