Trial · NCT01977573
A Study to Evaluate Safety and Efficacy of GSK1278863 in Non-Dialysis Dependent (NDD) Subjects With Anemia Associated With Chronic Kidney Diseases (CKD)
NCT01977573, Phase 2, Completed, GlaxoSmithKline; results first posted 2016-06-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate Safety and Efficacy of GSK1278863 in Non-Dialysis Dependent (NDD) Subjects With Anemia Associated With Chronic Kidney Diseases (CKD). Trials, record NCT01977573. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01977573
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Safety and Efficacy of GSK1278863 in Non-Dialysis Dependent (NDD) Subjects With Anemia Associated With Chronic Kidney Diseases (CKD)
- NCT number
- NCT01977573
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 252 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Anaemia
- Interventions
- GSK1278863, rhEPO
- First posted
- 2013-11-06
- Last updated
- 2018-10-12
- Results first posted
- 2016-06-06
Source ClinicalTrials.gov
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Summary of Hemoglobin (Hgb) Concentration at Week 24 | Week 24 | The original Hgb Criteria for Group 1- rhEPO naive participants with a stable baseline Hgb of 8.0-10.0 g/dL (8.0-10.0 g/dL USA site only) and for Group 2- rhEPO users with a stable baseline Hgb of 9.0-10.5 g/dL (9.0-10.5 g/dL USA site only); the Hgb target range was 9.0 to 10.5 g/dL (9.0-10.5 g/dL USA site only). The study amended Hgb Criteria for Group 1- rhEPO naive participants with a stable baseline Hgb of 8.0-11.0 g/dL and Group 2- rhEPO users with a stable baseline Hgb of 9.0-11.5 g/dL; Hgb target range - 10.0 to 11.5 g/dL. Data are presented for those participants following the original criteria ("Original") and those following the amended ("Amended") criteria. The primary objective was to characterize the ability of GSK1278863 to achieve mean Hgb response within the target range. |
| Secondary | Number of Participants With Hemoglobin (Hgb) in the Target Range at Week 24 | Week 24 | Target range is defined as: Original Hgb Criteria of 9.0 to 10.5 gram/deciliter (g/dL), and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL. |
| Secondary | Number of Participants Reaching Pre-defined Hgb Stopping Criteria | Over a period of 24 Weeks | The Hgb stopping criteria was a value of \<7.5 mg/dL obtained on-site via a validated point-of-care Hgb measurement device, which necessitated permanent discontinuation of the study medication. None of the participants met the stopping criteria therefore there is no data to present for this outcome measure. |
| Secondary | Percent Change From Baseline in Hepcidin Concentration at Week 24 | Baseline and Week 24 | Baseline is the last pre-dose hepcidin value. Percent change was calculated as 100 multiplied by (exponential of mean change on log scale minus 1). Change was calculated by subtracting the Baseline value from the Week 24 value. |
| Secondary | Maximum Observed Change From Baseline in Serum Erythropoietin (EPO) | Baseline to Week 24 | Blood samples for control arm were collected pre-dose for EPO measurement. Blood samples for GSK1278863 arms were collected on Day 1 (pre-dose ), Week 4 (6-12 hours post-dose ), Week 4 (7-13, 8-14, 9-15, hours post-dose ), Week 8 (pre -dose ), Week 12 (pre -dose ), Week 16 (pre -dose ), Week 20 (pre -dose , 3 hour post-dose ) Week 24 (pre -dose ), and Week 28 (pre -dose ) for EPO measurement. The maximum observed change from baseline in EPO was recorded for each arm. Baseline value for EPO is the pre-dose value on Day 1. Change from Baseline in EPO was calculated as the individual post-baseline values minus the Baseline value. |
| Secondary | Maximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF) | Baseline and up to Week 24 | Blood samples for control arm were collected pre-dose for VEGF measurement. Blood samples for GSK1278863 arms were collected on Day 1 (pre-dose ), Week 4 (6-12 hours post-dose ), Week 4 (7-13, 8-14, 9-15, hours post-dose ), Week 8 (pre -dose ), Week 12 (pre -dose ), Week 16 (pre -dose ), Week 20 (pre -dose , 3 hour post-dose ) Week 24 (pre -dose ), and Week 28 (pre -dose ) for VEGF measurement. The maximum observed change from baseline in VEGF was recorded for each arm . Baseline value for VEGF is the pre-dose value on Day 1. Change from Baseline in VEGF was calculated as the individual post-baseline values minus the Baseline value. |
| Secondary | Percentage of Time Within, Below, and Above Hemoglobin (Hgb) Target Range, Between Weeks 12 and 24 | Weeks 12 to 24 | The number of days a participant's Hgb was within target range was calculated by estimating (using linear interpolation) the number of days within target range between two scheduled Hgb visits. Percentage of time within range for a participant was calculated by dividing the total number of days that Hgb was within range during Weeks 12 to 24 by the total number of days the participant remained on treatment during Weeks 12 to 24. Similary, percent of time above and below Hgb target range was calculated. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL. |
| Secondary | Change From Baseline in Ferritin Concentration at Week 24 | Baseline and Week 24 | Baseline is the last pre-dose ferritin value. Change was calculated by subtracting the Baseline value from the Week 24 value. |
| Secondary | Change From Baseline in Transferrin Concentration at Week 24 | Baseline and Week 24 | Baseline is the last pre-dose transferrin value. Change from Baseline in transferrin was calculated by subtracting the Baseline value from the Week 24 value. |
| Secondary | Percent Change From Baseline in Transferrin Saturation at Week 24 | Baseline and Week 24 | Transferrin saturation is measured as a percentage; it is a ratio of serum iron and total iron-binding capacity. Baseline is the last pre-dose transferrin saturation value. Percent change was calculated as 100 multiplied by (exponential of mean change on log scale minus 1). Change was calculated by subtracting the Baseline value from the post-dose value. |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 registered outcomesOutcomes30
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 outcomesResults by group270
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Summary of Hemoglobin (Hgb) Concentration at Week 24 | rhEPO-Naive GSK1278863 | Original n=45,15,19,13 | 10.20 | Standard Deviation 0.906 | grams per deciliter |
| Summary of Hemoglobin (Hgb) Concentration at Week 24 | rhEPO-Naive Control | Original n=45,15,19,13 | 10.64 | Standard Deviation 0.664 | grams per deciliter |
| Summary of Hemoglobin (Hgb) Concentration at Week 24 | rhEPO-User GSK1278863 | Original n=45,15,19,13 | 10.03 | Standard Deviation 0.522 | grams per deciliter |
| Summary of Hemoglobin (Hgb) Concentration at Week 24 | rhEPO-User Control | Original n=45,15,19,13 | 10.66 | Standard Deviation 0.620 | grams per deciliter |
| Summary of Hemoglobin (Hgb) Concentration at Week 24 | rhEPO-Naive GSK1278863 | Amended n=61,21,11,17 | 10.96 | Standard Deviation 1.044 | grams per deciliter |
| Summary of Hemoglobin (Hgb) Concentration at Week 24 | rhEPO-Naive Control | Amended n=61,21,11,17 | 11.05 | Standard Deviation 1.144 | grams per deciliter |
| Summary of Hemoglobin (Hgb) Concentration at Week 24 | rhEPO-User GSK1278863 | Amended n=61,21,11,17 | 10.42 | Standard Deviation 0.827 | grams per deciliter |
| Summary of Hemoglobin (Hgb) Concentration at Week 24 | rhEPO-User Control | Amended n=61,21,11,17 | 10.86 | Standard Deviation 1.182 | grams per deciliter |
| Number of Participants With Hemoglobin (Hgb) in the Target Range at Week 24 | rhEPO-Naive GSK1278863 | 78 | participants | ||
| Number of Participants With Hemoglobin (Hgb) in the Target Range at Week 24 | rhEPO-Naive Control | 20 | participants |
1 to 10 of 270Source ClinicalTrials.gov
See all 270 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | rhEPO-Naive GSK1278863 | 136 | |
| Overall Study | STARTED | rhEPO-Naive Control | 44 | |
| Overall Study | STARTED | rhEPO-User GSK1278863 | 36 | |
| Overall Study | STARTED | rhEPO-User Control | 36 | |
| Overall Study | COMPLETED | rhEPO-Naive GSK1278863 | 116 | |
| Overall Study | COMPLETED | rhEPO-Naive Control | 41 | |
| Overall Study | COMPLETED | rhEPO-User GSK1278863 | 32 | |
| Overall Study | COMPLETED | rhEPO-User Control | 33 | |
| Overall Study | NOT COMPLETED | rhEPO-Naive GSK1278863 | 20 | |
| Overall Study | NOT COMPLETED | rhEPO-Naive Control | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events328
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 | NASOPHARYNGITIS | Infections and infestations | rhEPO-Naive GSK1278863 | 15 | 134 | |
| other | NASOPHARYNGITIS | Infections and infestations | rhEPO-Naive Control | 2 | 45 | |
| other | NASOPHARYNGITIS | Infections and infestations | rhEPO-User GSK1278863 | 7 | 36 | |
| other | NASOPHARYNGITIS | Infections and infestations | rhEPO-User Control | 2 | 35 | |
| other | CONJUNCTIVITIS | Infections and infestations | rhEPO-Naive GSK1278863 | 1 | 134 | |
| other | CONJUNCTIVITIS | Infections and infestations | rhEPO-Naive Control | 0 | 45 | |
| other | CONJUNCTIVITIS | Infections and infestations | rhEPO-User GSK1278863 | 2 | 36 | |
| other | CONJUNCTIVITIS | Infections and infestations | rhEPO-User Control | 0 | 35 | |
| other | BRONCHITIS | Infections and infestations | rhEPO-Naive GSK1278863 | 2 | 134 | |
| other | BRONCHITIS | Infections and infestations | rhEPO-Naive Control | 1 | 45 |
1 to 10 of 328Source ClinicalTrials.gov
See all 328 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | rhEPO-Naive GSK1278863 | ||
| Total, all-cause mortality | rhEPO-Naive Control | ||
| Total, all-cause mortality | rhEPO-User GSK1278863 | ||
| Total, all-cause mortality | rhEPO-User Control | ||
| Total, other adverse events | rhEPO-Naive GSK1278863 | 47 | 134 |
| Total, other adverse events | rhEPO-Naive Control | 14 | 45 |
| Total, other adverse events | rhEPO-User GSK1278863 | 20 | 36 |
| Total, other adverse events | rhEPO-User Control | 13 | 35 |
| Total, serious adverse events | rhEPO-Naive GSK1278863 | 23 | 134 |
| Total, serious adverse events | rhEPO-Naive Control | 7 | 45 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36005278 | DERIVED |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| rhEPO-Naive GSK1278863 vs rhEPO-User GSK1278863: Number of Participants With at Least One Dose Cycle up to 24 Weeks |
Source Trial comparisons
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/NCT01977573
GET https://conductscience.org/api/trials/v1/NCT01977573/registered?page=2