Trial · NCT01587924
4 Week Switch Study in Hemodialysis-dependent Subjects With Anemia Associated With Chronic Kidney Disease
NCT01587924, Phase 2, Completed, GlaxoSmithKline; results first posted 2017-09-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 4 Week Switch Study in Hemodialysis-dependent Subjects With Anemia Associated With Chronic Kidney Disease. Trials, record NCT01587924. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01587924
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 4 Week Switch Study in Hemodialysis-dependent Subjects With Anemia Associated With Chronic Kidney Disease
- NCT number
- NCT01587924
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 80 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Anaemia
- Interventions
- GSK1278863, rhEPO
- First posted
- 2012-04-30
- Last updated
- 2017-11-14
- Results first posted
- 2017-09-12
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | ITT population. Only those participants available at the specified time points were analyzed. | Grams per deciliter (g/dL) | MEAN |
| SECONDARY | Hgb Variability Over 4 Weeks | Up to 4 weeks | ITT population. Only those participants available at the specified time points were analyzed. | g/dL | MEAN |
| SECONDARY | Evaluation of Change From Baseline in Hepcidin Over Period | Baseline (pre-dose on Day 1) and up to 4 weeks | ITT population. Only those participants available at the specified time points were analyzed. | Micrograms per liter (mcg/L) | LEAST_SQUARES_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 | ITT population. Only those participants available at the specified time points were analyzed. | Milligrams per liter (mg/L) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline for Erythropoeitin (EPO) Over Period | Baseline (pre-dose on Day 1) and up to 4 weeks | ITT population. Only those participants available at the specified time points were analyzed. | Units per liter (U/L) | LEAST_SQUARES_MEAN |
| 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 | ITT population. Only those participants available at the specified time points were analyzed. | Nanograms per liter (ng/L) | LEAST_SQUARES_MEAN |
| 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 | ITT population. Only those participants available at the specified time points were analyzed. | Percentage | MEAN |
| SECONDARY | Residual Standard Deviation in Hgb (From the Linear Regression) | Up to 4 weeks | ITT population. Only those participants available at the specified time points were analyzed. | g/L | MEAN |
| 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 | ITT population. Only those participants available at the specified time points were analyzed. | Days | MEDIAN |
| 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 | ITT population. Only those participants available at the specified time points were analyzed. | Micrograms per liter | LEAST_SQUARES_MEAN |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group206
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Modeled Hemoglobin (Hgb) Change From Baseline (Pre-dose on Day 1) at 4 Weeks of Treatment | 0.5 mg GSK1278863 | -1.130 | Standard Deviation 0.6830 | Grams per deciliter (g/dL) | |
| Modeled Hemoglobin (Hgb) Change From Baseline (Pre-dose on Day 1) at 4 Weeks of Treatment | 2 mg GSK1278863 | -1.070 | Standard Deviation 0.7703 | Grams per deciliter (g/dL) | |
| Modeled Hemoglobin (Hgb) Change From Baseline (Pre-dose on Day 1) at 4 Weeks of Treatment | 5 mg GSK1278863 | 0.212 | Standard Deviation 0.7521 | Grams per deciliter (g/dL) | |
| Modeled Hemoglobin (Hgb) Change From Baseline (Pre-dose on Day 1) at 4 Weeks of Treatment | rhEPO | -0.273 | Standard Deviation 0.6335 | Grams per deciliter (g/dL) | |
| Hgb Variability Over 4 Weeks | 0.5 mg GSK1278863 | 0.53 | Standard Deviation 0.271 | g/dL | |
| Hgb Variability Over 4 Weeks | 2 mg GSK1278863 | 0.55 | Standard Deviation 0.325 | g/dL | |
| Hgb Variability Over 4 Weeks | 5 mg GSK1278863 | 0.40 | Standard Deviation 0.364 | g/dL | |
| Hgb Variability Over 4 Weeks | rhEPO | 0.35 | Standard Deviation 0.193 | g/dL | |
| Evaluation of Change From Baseline in Hepcidin Over Period | 0.5 mg GSK1278863 | 204.88 | Standard Error 60.741 | Micrograms per liter (mcg/L) | |
| Evaluation of Change From Baseline in Hepcidin Over Period | 2 mg GSK1278863 | 150.29 | Standard Error 62.619 | Micrograms per liter (mcg/L) |
1 to 10 of 206Source ClinicalTrials.gov
See all 206 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 0.5 mg GSK1278863 | 21 | |
| Overall Study | STARTED | 2 mg GSK1278863 | 21 | |
| Overall Study | STARTED | 5 mg GSK1278863 | 21 | |
| Overall Study | STARTED | rhEPO | 20 | |
| Overall Study | COMPLETED | 0.5 mg GSK1278863 | 17 | |
| Overall Study | COMPLETED | 2 mg GSK1278863 | 17 | |
| Overall Study | COMPLETED | 5 mg GSK1278863 | 17 | |
| Overall Study | COMPLETED | rhEPO | 19 | |
| Overall Study | NOT COMPLETED | 0.5 mg GSK1278863 | 4 | |
| Overall Study | NOT COMPLETED | 2 mg GSK1278863 | 4 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events20
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | 0.5 mg GSK1278863 | 3 | 21 | |
| other | Anemia | Blood and lymphatic system disorders | 2 mg GSK1278863 | 1 | 21 | |
| other | Anemia | Blood and lymphatic system disorders | 5 mg GSK1278863 | 0 | 20 | |
| other | Anemia | Blood and lymphatic system disorders | rhEPO | 0 | 20 | |
| serious | Constipation | Gastrointestinal disorders | 0.5 mg GSK1278863 | 0 | 21 | |
| serious | Constipation | Gastrointestinal disorders | 2 mg GSK1278863 | 1 | 21 | |
| serious | Constipation | Gastrointestinal disorders | 5 mg GSK1278863 | 0 | 20 | |
| serious | Constipation | Gastrointestinal disorders | rhEPO | 0 | 20 | |
| serious | Gastrointestinal hemorrhage | Gastrointestinal disorders | 0.5 mg GSK1278863 | 0 | 21 | |
| serious | Gastrointestinal hemorrhage | Gastrointestinal disorders | 2 mg GSK1278863 | 1 | 21 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 0.5 mg GSK1278863 | 0 | 21 |
| Total, all-cause mortality | 2 mg GSK1278863 | 0 | 21 |
| Total, all-cause mortality | 5 mg GSK1278863 | 0 | 20 |
| Total, all-cause mortality | rhEPO | 0 | 20 |
| Total, other adverse events | 0.5 mg GSK1278863 | 3 | 21 |
| Total, other adverse events | 2 mg GSK1278863 | 1 | 21 |
| Total, other adverse events | 5 mg GSK1278863 | 0 | 20 |
| Total, other adverse events | rhEPO | 0 | 20 |
| Total, serious adverse events | 0.5 mg GSK1278863 | 0 | 21 |
| Total, serious adverse events | 2 mg GSK1278863 | 2 | 21 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01587924
GET https://conductscience.org/api/trials/v1/NCT01587924/registered?page=2