Trial · NCT01977573
Outcomes30
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 30
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Summary of Hemoglobin (Hgb) Concentration at Week 24 | Week 24 | Intent-to-Treat (ITT): The ITT population consisted of all randomized participants who received at least one dose of study drug, had a Baseline and at least one corresponding on-treatment assessment. Only participants who were available at the indicated time point were analyzed. | grams per deciliter | MEAN |
| SECONDARY | Number of Participants With Hemoglobin (Hgb) in the Target Range at Week 24 | Week 24 | ITT population. Only participants who were available at the indicated time point were analyzed. | participants | NUMBER |
| SECONDARY | Number of Participants Reaching Pre-defined Hgb Stopping Criteria | Over a period of 24 Weeks | ITT population. | Participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Hepcidin Concentration at Week 24 | Baseline and Week 24 | Intent-to-Treat (ITT) population consisted all randomized participants who received at least one dose of study drug, had a Baseline and at least one corresponding on-treatment assessment. Only participants with available hepcidin values at Baseline and Week 24 were analyzed. | percent change in Hepcidin | GEOMETRIC_MEAN |
| SECONDARY | Maximum Observed Change From Baseline in Serum Erythropoietin (EPO) | Baseline to Week 24 | ITT population. Only participants having a Baseline EPO measurement and at least one post-baseline EPO measurement were analyzed. | International Units per liter | MEAN |
| SECONDARY | Maximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF) | Baseline and up to Week 24 | ITT population. Only participants with data available at Baseline and a maximum observed change were analyzed. | percent change in VEGF concentration | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Time Within, Below, and Above Hemoglobin (Hgb) Target Range, Between Weeks 12 and 24 | Weeks 12 to 24 | ITT population. Only participants with data available at specific time points were analyzed. | percentage of days | MEAN |
| SECONDARY | Change From Baseline in Ferritin Concentration at Week 24 | Baseline and Week 24 | ITT population. Only participants with data available at specific time point were analyzed. | micrograms per liter | MEAN |
| SECONDARY | Change From Baseline in Transferrin Concentration at Week 24 | Baseline and Week 24 | ITT population. Only participants with data available at specific time point were analyzed. | grams per liter | MEAN |
| SECONDARY | Percent Change From Baseline in Transferrin Saturation at Week 24 | Baseline and Week 24 | ITT population. Only participants with data available at specific time point were analyzed. | percent change | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Total Iron at Week 24 | Baseline and Week 24 | ITT population. Only participants with available total iron values at Baseline and Week 24 were analyzed. | micromoles per liter | MEAN |
| SECONDARY | Change From Baseline in Total Iron Binding Capacity (TIBC) at Week 24 | Baseline and Week 24 | ITT population. Only participants with data available at specific timepoint were analyzed. | micromoles per liter | MEAN |
| SECONDARY | Change From Baseline in Reticulocyte Hemoglobin (CHr) at Week 24 | Baseline and Week 24 | ITT population. Only participants with data available at specific time point were analyzed. | picogram | MEAN |
| SECONDARY | Change From Baseline in Hematocrit at Week 24 | Baseline and Week 24 | ITT population. Only participants with data available at specific timepoint were analyzed. | percentage change in Fraction of 1 | MEAN |
| SECONDARY | Change From Baseline in Red Blood Cell Count at Week 24 | Baseline and Week 24 | ITT population. Only participants with data available at specific time point were analyzed. | 10^12 cells per liter | MEAN |
| SECONDARY | Change From Baseline in Reticulocyte Cell Count at Week 24 | Baseline and Week 24 | ITT population. Only participants with data available at specific timepoint were analyzed. | percentage of reticulocytes | MEAN |
| SECONDARY | Concentration of GSK1278863 and Relevant Metabolites as a Population Pharmacokinetic Endpoint | Day 1 (pre-dose), Week (Wk) 4 (6-12 hour, 7-13 hour, 8-14 hour, 9-15 hour post-dose), and Wk 20 (pre-dose, 1 hour, 2 hour, 3 hour post-dose) | Pharmacokinetics (PK) population: All participants from whom a PK sample was obtained and analyzed. This population did not include participants from the control groups. | nanograms per milliliter | MEAN |
| SECONDARY | Mean Number of Dose Adjustments up to 24 Weeks | From Week 4 up to 24 Weeks | Intent-to-Treat population. Only those participants with at least one dose adjustment of GSK1278863 were analyzed. | number of adjustments | MEAN |
| SECONDARY | Number of Participants With Dose Adjustments up to 24 Weeks, as a Measure of Dose Adjustment Frequency | From week 4 up to 24 weeks | Intent-to-Treat population. Only those participants with at least one dose adjustment of GSK1278863 were analyzed. | participants | NUMBER |
| SECONDARY | Timing of Dose Adjustments at Weeks 4, 8, 12, 16, and 20 | From Week 4 up to Week 20 | ITT population. Only those participants with at least one dose adjustment of GSK1278863 were analyzed. | Participants | NUMBER |
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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