Trial · NCT02829320

Efficacy and Safety Study of GSK1278863 in Japanese Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease Who Are Not Taking Erythropoiesis Stimulating Agents

NCT02829320, Phase 3, Completed, GlaxoSmithKline; results first posted 2018-07-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety Study of GSK1278863 in Japanese Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease Who Are Not Taking Erythropoiesis Stimulating Agents. Trials, record NCT02829320. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02829320

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety Study of GSK1278863 in Japanese Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease Who Are Not Taking Erythropoiesis Stimulating Agents
NCT number: NCT02829320
Status: Completed
Phases: Phase 3
Enrollment: 28 participants, actual
Lead sponsor: GlaxoSmithKline
Conditions: Anaemia
Interventions: GSK1278863, Iron
First posted: 2016-07-12
Last updated: 2019-12-03
Results first posted: 2018-07-13

Source ClinicalTrials.gov

Registered outcomes22

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Hgb at Week 4	Baseline and Week 4	Blood samples were collected from participants for measurement of Hgb values. The Baseline value was the latest pre-dose assessment. Change from Baseline at Week 4 was calculated by subtracting Baseline value from the post-dose visit value. The analysis was performed on All Treated Subjects Population which comprised of all participants who received at least one dose of GSK1278863.
Primary	Number of Participants by Hgb Change From Baseline Category at Week 4	Baseline and Week 4	Blood samples were collected from participants for measurement of Hgb values. The Baseline value was the latest pre-dose assessment. Change from Baseline at Week 4 was calculated by subtracting Baseline value from the post-dose visit value. The change in Hgb at Week 4 was classified into different categories (i.e., \<=-2.0, \>-2.0 to -1.0, \>-1.0 to 0, \>0 to 1.0, \>1.0 to 2.0, and \>2 g/dL), and the number of participants in each category were summarized.
Secondary	Hgb Values at the Indicated Time Points	Up to Week 24	Blood samples were collected from participants for measurement of Hgb values at indicated time points. Hgb was evaluated using Hgb analyzer.
Secondary	Change From Baseline in Hgb at the Indicated Time Points	Baseline and up to Week 24	Blood samples were collected from participants for measurement of Hgb values at indicated time points. Hgb was evaluated using Hgb analyzer. The Baseline value was the latest pre-dose assessment. Change from Baseline at indicated time-points was calculated by subtracting Baseline value from the post-dose visit value.
Secondary	Number of Participants Who Had Hgb Level Within the Target Range (10.0-12.0 g/dL)	Up to Week 24	Blood samples were collected from participants for measurement of Hgb values at indicated time points. Hgb was evaluated using Hgb analyzer. The number of participants with Hgb withinthe target range (10.0 to 12.0 g/dL) at each assessment visit was summarized.
Secondary	Time to Reach the Lower Target Hgb Level (10.0 g/dL)	Up to Week 24	Blood samples were collected from participants for measurement of Hgb values at indicated time points. Hgb was evaluated using Hgb analyzer. Participants who could not reach lower target were regarded as censored. The time (in days) to reach the lower target Hgb level (10.0 g/dL) was summarized using 25th percentile (P25), median, and 75th percentile (P75) by Kaplan-Meier method.
Secondary	Number of Participants Who Had Hgb Level of Less Than 7.5 g/dL	Up to Week 24	Blood samples were collected from participants for measurement of Hgb values at indicated time points. Hgb was evaluated using Hgb analyzer. The number of participants who had Hgb level of less than 7.5 g/dL were summarized. On-therapy Hgb values observed in both scheduled and unscheduled visits were included.
Secondary	Number of Participants Who Had Hgb Increase of More Than 2 g/dL Over Any 4 Weeks	Up to Week 24	Blood samples were collected from participants for measurement of Hgb values at indicated time points. Hgb was evaluated using Hgb analyzer. The number of participants who had Hgb increase of more than 2.0 g/dL over any 4 weeks were summarized. On-therapy Hgb values observed in both scheduled and unscheduled visits were included.
Secondary	Number of Participants Who Had Hgb Level of More Than 13.0 g/dL	Up to Week 24	Blood samples were collected from participants for measurement of Hgb values at indicated time points. Hgb was evaluated using Hgb analyzer. The number of participants who had Hgb level of more than 13.0 g/dL were summarized. On-therapy Hgb values observed in both scheduled and unscheduled visits were included.
Secondary	Number of Episodes of Achieving Hgb Level of More Than 13.0 g/dL	Up to Week 24	Blood samples were collected from participants for measurement of Hgb values at indicated time points. Hgb was evaluated using Hgb analyzer. The number of episodes in participants who had Hgb level of more than 13.0 g/dL were summarized. On-therapy Hgb values observed in both scheduled and unscheduled visits were included.

1 to 10 of 22Source ClinicalTrials.gov

See all 22 registered outcomes

Outcomes22

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Hgb at Week 4	Baseline and Week 4	All Treated Subjects Population	G/dL	MEAN
PRIMARY	Number of Participants by Hgb Change From Baseline Category at Week 4	Baseline and Week 4	All Treated Subjects Population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Hgb Values at the Indicated Time Points	Up to Week 24	All Treated Subjects Population	G/dL	MEAN
SECONDARY	Change From Baseline in Hgb at the Indicated Time Points	Baseline and up to Week 24	All Treated Subjects Population	G/dL	MEAN
SECONDARY	Number of Participants Who Had Hgb Level Within the Target Range (10.0-12.0 g/dL)	Up to Week 24	All Treated Subjects Population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Time to Reach the Lower Target Hgb Level (10.0 g/dL)	Up to Week 24	All Treated Subjects Population	Days	MEDIAN
SECONDARY	Number of Participants Who Had Hgb Level of Less Than 7.5 g/dL	Up to Week 24	All Treated Subjects Population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Who Had Hgb Increase of More Than 2 g/dL Over Any 4 Weeks	Up to Week 24	All Treated Subjects Population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Who Had Hgb Level of More Than 13.0 g/dL	Up to Week 24	All Treated Subjects Population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Episodes of Achieving Hgb Level of More Than 13.0 g/dL	Up to Week 24	All Treated Subjects Population	Episodes	NUMBER

1 to 10 of 22Source ClinicalTrials.gov

See all 22 outcomes

Results by group103

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Hgb at Week 4	All Participants		0.79	95% Confidence Interval 0.53 to 1.05	G/dL
Number of Participants by Hgb Change From Baseline Category at Week 4	All Participants	<= -2.0	0		Participants
Number of Participants by Hgb Change From Baseline Category at Week 4	All Participants	> -2.0 to -1.0	0		Participants
Number of Participants by Hgb Change From Baseline Category at Week 4	All Participants	> -1.0 to 0	4		Participants
Number of Participants by Hgb Change From Baseline Category at Week 4	All Participants	> 0 to 1.0	13		Participants
Number of Participants by Hgb Change From Baseline Category at Week 4	All Participants	> 1.0 to 2.0	11		Participants
Number of Participants by Hgb Change From Baseline Category at Week 4	All Participants	> 2.0	0		Participants
Hgb Values at the Indicated Time Points	All Participants	Day 1	9.10	Standard Deviation 0.696	G/dL
Hgb Values at the Indicated Time Points	All Participants	Week 4	9.90	Standard Deviation 0.907	G/dL
Hgb Values at the Indicated Time Points	All Participants	Week 8	10.76	Standard Deviation 0.957	G/dL

1 to 10 of 103Source ClinicalTrials.gov

See all 103 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	All Participants	28
Overall Study	COMPLETED	All Participants	28
Overall Study	NOT COMPLETED	All Participants	0

Source ClinicalTrials.gov

Adverse events5

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	All Participants	9	28	10
other	Infected dermal cyst	Infections and infestations	All Participants	2	28	3
other	Shunt stenosis	Injury, poisoning and procedural complications	All Participants	2	28	2
serious	Shunt occlusion	Injury, poisoning and procedural complications	All Participants	2	28	3
serious	Device dislocation	Product Issues	All Participants	1	28	1

Source ClinicalTrials.gov

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	All Participants	0	28
Total, other adverse events	All Participants	12	28
Total, serious adverse events	All Participants	3	28

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
31306555	BACKGROUND

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 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02829320

GET https://conductscience.org/api/trials/v1/NCT02829320/registered?page=2

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