Trial · NCT01587898
4 Week Correction Study in Subjects With Anemia Associated With Chronic Kidney Disease Who Are Not Undergoing Dialysis
NCT01587898, Phase 2, Completed, GlaxoSmithKline; results first posted 2017-11-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 4 Week Correction Study in Subjects With Anemia Associated With Chronic Kidney Disease Who Are Not Undergoing Dialysis. Trials, record NCT01587898. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01587898
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 4 Week Correction Study in Subjects With Anemia Associated With Chronic Kidney Disease Who Are Not Undergoing Dialysis
- NCT number
- NCT01587898
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 72 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Anaemia
- Interventions
- GSK1278863, Placebo
- First posted
- 2012-04-30
- Last updated
- 2017-11-09
- Results first posted
- 2017-11-09
Source ClinicalTrials.gov
Registered outcomes43
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Modeled Hgb Change From Baseline Over 4 Weeks of Treatment | Baseline (average of Week -2, -1 and Day 1) and Week 4 | Modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model. The model included fixed effects for baseline Hgb, treatment and a treatment by day interaction. Random effects was fitted in the intercept and the slope over time. All data up until investigational product discontinuation was included for Hgb efficacy evaluable participants; where efficacy evaluable was defined as having a baseline and at least 2 on-treatment Hgb assessments. Baseline was the average of Week -2 , Week -1 and Day 1 visits. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values. |
| Secondary | Model-Adjusted Maximum Hgb Changes Over 4 Weeks | Baseline (average of Week -2 , -1 and Day 1 visits) and 4 weeks | Maximum Hgb change over 4 weeks was analyzed using an ANCOVA model with terms included for treatment and baseline Hgb value. Least square mean estimates and 95% CI for each treatment group were reported. Baseline was the average of Week -2 , Week -1 and Day 1 visits. The change from Baseline was calculated by subtracting the baseline value from the individual post-dose visit values. |
| 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 | Number of participants achieving an increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb from baseline were reported. Entry into the study required a target stable Hgb of 8.5-11.0 g/dL. A stable Hgb value was confirmed from three Hgb values taken during the screening period at Week -2, Week -1 and Day 1 (randomization). The average of these three values was used for Baseline Hgb. |
| 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 | Percentage of participants achieving an increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb from baseline were reported. Entry into the study requires a target stable Hgb of 8.5-11.0 g/dL. A stable Hgb value was confirmed from three Hgb values taken during the screening period at Week -2, Week -1 and Day 1 (randomization). The average of these three values was used for Baseline Hgb. |
| Secondary | Number of Participants Who Reached Hgb Stopping Criteria | Up to Week 4 | The Hgb stopping criteria was defined as reaching to value \<8.0 g/dL, \>=8.0 - \<13.0 (\>= 2g/dL absolute Hgb change over 1 week ) or \>=13.0 g/dL. The number of participants who reached the Hgb stopping criteria of Hgb concentration were presented. |
| Secondary | Change From Baseline in Hepcidin at Week 2 and Week 4 | Baseline (Pre-dose on Day 1), Week 2 and 4 | Blood samples for hepcidin were collected at Day 1 (pre-dose), Week 2 (approximately between 4 to 8 h) and Week 4 (pre-dose). Hepcidin is a regulator of iron metabolism. Baseline was the last pre-dose value on Day 1. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values. Where hepcidin values were missing because the value was below the quantification limit (BQL), the BQL value was imputed. |
| Secondary | Change From Baseline in Ferritin at Week 2 and Week 4 | Baseline (Day 1 Pre-dose), Week 2 and 4 | Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values. |
| Secondary | Change From Baseline in Transferrin at Week 2 and Week 4 | Baseline (Day 1 Pre-dose), Week 2 and 4 | Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values. |
| Secondary | Change From Baseline in Transferrin Saturation at Week 2 and Week 4 | Baseline (Day 1 Pre-dose), Week 2 and 4 | Transferrin saturation was measured as a percentage, and is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Baseline value for transferrin saturation was the pre-dose value on Day 1. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values. |
| Secondary | Change From Baseline in Total Iron Binding Capacity at Week 2 and Week 4 | Baseline (Day 1 Pre-dose), Week 2 and 4 | Total iron-binding capacity is a medical laboratory test that measures the blood's capacity to bind iron with transferrin. Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values. |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 registered outcomesOutcomes43
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 outcomesResults by group1,505
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Modeled Hgb Change From Baseline Over 4 Weeks of Treatment | Placebo | -0.148 | Standard Deviation 0.1925 | gram per decilitre (g/dL) | |
| Modeled Hgb Change From Baseline Over 4 Weeks of Treatment | GSK1278863, 0.5 mg | 0.132 | Standard Deviation 0.2200 | gram per decilitre (g/dL) | |
| Modeled Hgb Change From Baseline Over 4 Weeks of Treatment | GSK1278863, 2 mg | 0.463 | Standard Deviation 0.2173 | gram per decilitre (g/dL) | |
| Modeled Hgb Change From Baseline Over 4 Weeks of Treatment | GSK1278863, 5 mg | 1.010 | Standard Deviation 0.2614 | gram per decilitre (g/dL) | |
| Model-Adjusted Maximum Hgb Changes Over 4 Weeks | Placebo | 0.153 | Standard Error 0.1476 | g/dL | |
| Model-Adjusted Maximum Hgb Changes Over 4 Weeks | GSK1278863, 0.5 mg | 0.137 | Standard Error 0.1609 | g/dL | |
| Model-Adjusted Maximum Hgb Changes Over 4 Weeks | GSK1278863, 2 mg | 0.474 | Standard Error 0.1532 | g/dL | |
| Model-Adjusted Maximum Hgb Changes Over 4 Weeks | GSK1278863, 5 mg | 1.069 | Standard Error 0.1527 | g/dL | |
| Number of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Placebo | Decrease/increase of < 0.5 g/dL | 16 | Participants | |
| Number of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | GSK1278863, 0.5 mg | Decrease/increase of < 0.5 g/dL | 12 | Participants |
1 to 10 of 1,505Source ClinicalTrials.gov
See all 1,505 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 18 | |
| Overall Study | STARTED | GSK1278863, 0.5 mg | 17 | |
| Overall Study | STARTED | GSK1278863, 2 mg | 18 | |
| Overall Study | STARTED | GSK1278863, 5 mg | 19 | |
| Overall Study | COMPLETED | Placebo | 14 | |
| Overall Study | COMPLETED | GSK1278863, 0.5 mg | 12 | |
| Overall Study | COMPLETED | GSK1278863, 2 mg | 16 | |
| Overall Study | COMPLETED | GSK1278863, 5 mg | 17 | |
| Overall Study | NOT COMPLETED | Placebo | 4 | |
| Overall Study | NOT COMPLETED | GSK1278863, 0.5 mg | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events176
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 | Nausea | Gastrointestinal disorders | Placebo | 2 | 18 | |
| other | Nausea | Gastrointestinal disorders | GSK1278863, 0.5 mg | 2 | 17 | |
| other | Nausea | Gastrointestinal disorders | GSK1278863, 2 mg | 0 | 18 | |
| other | Nausea | Gastrointestinal disorders | GSK1278863, 5 mg | 1 | 19 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 18 | |
| other | Anaemia | Blood and lymphatic system disorders | GSK1278863, 0.5 mg | 0 | 17 | |
| other | Anaemia | Blood and lymphatic system disorders | GSK1278863, 2 mg | 1 | 18 | |
| other | Anaemia | Blood and lymphatic system disorders | GSK1278863, 5 mg | 0 | 19 | |
| other | Asthenia | General disorders | Placebo | 1 | 18 | |
| other | Asthenia | General disorders | GSK1278863, 0.5 mg | 1 | 17 |
1 to 10 of 176Source ClinicalTrials.gov
See all 176 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 18 |
| Total, all-cause mortality | GSK1278863, 0.5 mg | 0 | 17 |
| Total, all-cause mortality | GSK1278863, 2 mg | 0 | 18 |
| Total, all-cause mortality | GSK1278863, 5 mg | 0 | 19 |
| Total, other adverse events | Placebo | 8 | 18 |
| Total, other adverse events | GSK1278863, 0.5 mg | 10 | 17 |
| Total, other adverse events | GSK1278863, 2 mg | 5 | 18 |
| Total, other adverse events | GSK1278863, 5 mg | 5 | 19 |
| Total, serious adverse events | Placebo | 1 | 18 |
| Total, serious adverse events | GSK1278863, 0.5 mg | 0 | 17 |
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
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GET https://conductscience.org/api/trials/v1/NCT01587898
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