Trial · NCT01587924
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Modeled Hemoglobin (Hgb) Change From Baseline (Pre-dose on Day 1) at 4 Weeks of Treatment | Baseline (pre-dose on Day 1) and up to week 4 | Modeled Hgb change from Baseline over 4 weeks of treatment. Change from Baseline is the actual value of Hgb at Week 4 minus the Baseline value. For modeled change at Week 4 participants required a Baseline and two or more non missing post-baseline values. Baseline is the average of Week -2, -1 and Day 1 values. The model included fixed effects for Baseline Hgb, treatment, and treatment by day interaction. Covariate analysis for modeled Hgb change was performed. Random effects were fitted in the intercept and the slope over time. |
| Secondary | Hgb Variability Over 4 Weeks | Up to 4 weeks | Within participant standard deviation for Hgb acts as a measure of Hgb variability. Hgb of participants was recorded over 4 weeks. |
| Secondary | Evaluation of Change From Baseline in Hepcidin Over Period | Baseline (pre-dose on Day 1) and up to 4 weeks | Evaluation of change from baseline for hepcidin was performed over 4 weeks. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline was the last pre-dose value. Adjusted mean change from Baseline is presented as Least square (LS) mean. |
| Secondary | Evaluation of Change From Baseline (Pre-dose on Day 1) in High Sensitivity C-Reactive Protein (hsCRP) Over 4 Weeks | Baseline (pre-dose on Day 1) and up to 4 weeks | Evaluation of change from Baseline for hsCRP was analyzed over 4 weeks. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline was the last pre-dose value. Peak change from Baseline also was calculated; however adjusted mean change from Baseline has been presented here as LS means. |
| Secondary | Change From Baseline for Erythropoeitin (EPO) Over Period | Baseline (pre-dose on Day 1) and up to 4 weeks | Evaluation of change from Baseline (pre-dose on Day 1) for EPO was analyzed over 4 weeks. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline was the pre-dose Day 1 value. Adjusted means are presented as LS means. |
| Secondary | Evaluation of Change From Baseline (Pre-dose on Day 1) for Peak Vascular Endothelial Growth Factor (VEGF) Over 4 Weeks | Baseline (pre-dose on Day 1) and up to 4 weeks | Evaluation of change from Baseline for peak VEGF was analyzed up to 4 weeks. Baseline assessment was performed pre-dose on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value. Absolute mean change and peak change from Baseline in peak VGEF were also calculated; however, only model adjusted peak change in peak VGEF from Baseline has been presented as LS means. |
| Secondary | Evaluation of Change From Baseline (Pre-dose on Day 1) for Hematocrit Over 4 Weeks | Baseline (pre-dose on Day 1) and up to 4 weeks | Evaluation of change from Baseline for hematocrit over 4 weeks was performed. Change from Baseline is the value at indicated time point minus the Baseline value. |
| Secondary | Residual Standard Deviation in Hgb (From the Linear Regression) | Up to 4 weeks | Residual standard deviation was derived by linear regression. Hgb of participants was recorded over 4 weeks |
| Secondary | Number of Days Spent Within Hgb Range ( ±0.5 g/dL and ±1 g/dL ) From Baseline Hgb | Baseline (pre-dose on Day 1) and up to 4 weeks | Time spent with Hgb within range (where range was defined as +-0.5 g/dL and +-1 g/dL from baseline Hgb ) was analyzed. Baseline value of Hgb was recorded pre-dose on Day 1. |
| Secondary | Evaluation of Change From Baseline (Pre-dose on Day 1) in Ferritin Over 4 Weeks | Baseline (pre-dose on Day 1) and Week 4 | Change from Baseline (pre-dose on Day 1) in ferritin over 4 weeks was analyzed. Change from Baseline is the value at indicated time point minus the Baseline value. Model adjusted mean has been presented as LS mean. |
| Secondary | Evaluation of Change From Baseline (Pre-dose on Day 1) for Transferrin Over 4 Weeks | Baseline (pre-dose on Day 1) and Week 4 | Evaluation of change from Baseline for ferritin was performed over 4 weeks. Change from Baseline is the value at indicated time point minus the Baseline value. Model adjusted mean has been presented as LS mean. |
| Secondary | Change From Baseline (Pre-dose on Day 1) for Transferrin Saturation Over 4 Weeks | Baseline (pre-dose on Day 1) and Week 4 | Transferrin saturation is a medical laboratory test and is the ratio of serum iron and total iron-binding capacity, multiplied by 100 and expressed as a ratio. Evaluation of change from baseline for transferrin saturation was performed up to 4 weeks. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline value was recorded pre-dose on Day 1. Model adjusted mean values are presented as LS mean values. |
| Secondary | Change From Baseline (Pre-dose on Day 1) for Total Iron Over 4 Weeks | Baseline (pre-dose on Day 1) and at Week 4 | Evaluation of change from Baseline for total iron was performed over 4 weeks. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline was recorded pre-dose on Day 1. Adjusted mean was presented as LS mean. |
| Secondary | Change From Baseline (Pre-dose on Day 1) in Total Iron Binding Capacity Over 4 Weeks | Baseline (pre-dose on Day 1) and Week 4 | Evaluation of change from Baseline in total iron binding capacity was performed over 4 weeks. Baseline was recorded pre-dose on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value. Adjusted means are presented as LS means. |
| Secondary | Change From Baseline (Pre-dose on Day 1) for Red Blood Cells (RBCs) Over 4 Weeks | Baseline (pre-dose on Day 1) and up to 4 weeks | Change from Baseline in RBCs was a pharmacodynamic (PD) biomarker. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline was recorded pre-dose on Day 1. Change from Baseline (pre-dose on Day 1) in RBCs was calculated over 4 weeks. |
| Secondary | Change From Baseline (Pre-dose on Day 1) for Reticulocytes Over 4 Weeks | Baseline (pre-dose on Day 1) and up to 4 weeks | Evaluation of change from Baseline for reticulocytes was a PD parameter. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline value was recorded pre-dose on Day 1. |
| Secondary | Number of Participants Reaching Hgb Stopping Criteria | Up to 4 weeks | Participants were analyzed whether they had any increase or decrease from the Baseline Hgb. Hgb increase based stopping criteria included analysis of Increase or decrease of more than or equal to (\>=) 2 g/dL from the Baseline (pre-dose on Day 1) was recorded and also the participants with hemoglobin \>=13 g/dL were recorded. |
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 4 weeks | An AE is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. An SAE is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above. Only on-treatment data has been presented. |
| Secondary | Number of Participants Discontinuing the Study Treatment Due to AEs | Up to 4 weeks | Discontinuation of the study drug could be due to safety-related reasons AE. The AEs responsible included anemia, gastrointestinal hemorrhage, and nausea. |
| Secondary | Mean Plasma Concentration of GSK1278863 and GSK1278863 Metabolites Over 4 Weeks | Up to 4 weeks | Each of the plasma concentration-time plot contained one plot on the untransformed scale (i.e. a linear plot) and one plot on the log transformed scale (i.e. log-linear plot). Plasma concentrations were analyzed for the study drug (GSK1278863), and its metabolites namely GSK2391220 (M2), GSK2531403 (M3), GSK2487818A (M4), GSK2506102A (M5), GSK2531398 (M6), and GSK2531401A (M13). Pharmacokinetic analysis was done on Weeks (W) 2 and 4 at a fixed timely interval of 5 hours (h) on W2 and every hour on W4. Only the data for last visit for W2 and last visit of W4 has been presented. |
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.
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