Trial · NCT02689206

Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Three-times Weekly Dosing of GSK1278863 in Hemodialysis-dependent Subjects With Anemia Associated With Chronic Kidney Disease Who Are Switched From a Stable Dose of an Erythropoiesis-stimulating Agent

NCT02689206, Phase 2, Completed, GlaxoSmithKline; results first posted 2018-05-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Three-times Weekly Dosing of GSK1278863 in Hemodialysis-dependent Subjects With Anemia Associated With Chronic Kidney Disease Who Are Switched From a Stable Dose of an Erythropoiesis-stimulating Agent. Trials, record NCT02689206. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02689206

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Trial

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

Title: Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Three-times Weekly Dosing of GSK1278863 in Hemodialysis-dependent Subjects With Anemia Associated With Chronic Kidney Disease Who Are Switched From a Stable Dose of an Erythropoiesis-stimulating Agent
NCT number: NCT02689206
Status: Completed
Phases: Phase 2
Enrollment: 103 participants, actual
Lead sponsor: GlaxoSmithKline
Conditions: Anaemia
Interventions: GSK1278863, GSK1278863 matching Placebo
First posted: 2016-02-23
Last updated: 2020-02-25
Other registries' IDs: eudract:2015-004790-32
Results first posted: 2018-05-21

Source ClinicalTrials.gov

Registered outcomes40

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Hgb Levels at Day 29	Baseline and Day 29	Blood samples were collected from participants for measurement of Hgb values. Baseline is the average of Hgb measured at Week -2 and Day 1 visits. Change from Baseline at Day 29 was defined as post dose value at Day 29 minus Baseline value. The analysis was performed on intent-to-treat (ITT) Population which comprised of all randomized participants who received at least one dose of study treatment, had a Baseline and at least one corresponding on treatment assessment, including Hgb.
Secondary	Maximum Observed Change From Baseline in Plasma Erythropoietin (EPO)	Baseline and up to Day 29	Blood samples were collected at Day 1, Day 15 and Day 29 for pharmacodynamic analysis of effect of dapro three times weekly dose regimens on EPO. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. The change from Baseline at each given post-Baseline time point was calculated and the maximum change from Baseline was determined.
Secondary	Maximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF)	Baseline and up to Day 29	Blood samples were collected at Day 1, Day 15 and Day 29 for pharmacodynamic analysis of effect of dapro three times weekly dose regimens on VEGF. Day 1 values were considered as Baseline values. The percent change from Baseline at each given post-Baseline time point was calculated (expressed as geometric mean) and the maximum percent change from Baseline was determined.
Secondary	Percent Change From Baseline in Hepcidin at Day 29	Baseline and Day 29	Blood samples were collected at Day 1, Day 15 and Day 29 for pharmacodynamic analysis of effect of dapro three times weekly dose regimens on hepcidin. Day 1 values were considered as Baseline values. The Percent change from Baseline at Day 29 post-Baseline time point was calculated and expressed as geometric mean and the maximum change from Baseline was determined.
Secondary	Change From Baseline in Hematocrit Levels	Baseline and Day 29	Blood samples were collected at Day 1, Day 15 and Day 29 for pharmacodynamic analysis of effect Dapro three times weekly dose regimens on hematocrit. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-dose visit values minus Baseline value. The change from Baseline at Day 29 post-Baseline time point was calculated.
Secondary	Change From Baseline in Red Blood Cell (RBC) Count	Baseline and Day 29	Blood samples were collected at Day 1, Day 15 and Day 29 for pharmacodynamic analysis of effect Dapro three times weekly dose regimens on RBC count. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-dose visit values minus Baseline value. The change from Baseline at Day 29 post-Baseline time point was calculated.
Secondary	Change From Baseline in Reticulocyte Count	Baseline and Day 29	Blood samples were collected at Day 1, Day 15 and Day 29 for pharmacodynamic analysis of effect Dapro three times weekly dose regimens on reticulocyte count. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. The change from Baseline at Day 29 post-Baseline time point was calculated.
Secondary	Change From Baseline in Reticulocyte Hemoglobin (CHr)	Baseline and Day 29	Blood samples were collected at Day 1, Day 15 and Day 29 for pharmacodynamic analysis of effect Dapro three times weekly dose regimens on CHr. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. The change from Baseline at Day 29 post-Baseline time point was calculated.
Secondary	Area Under the Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) and AUC From Time Zero to Infinity (AUC[0-inf]) of Dapro	Pre-dose on Day 1; 6-10 hours, 7-11 hours, 8-12 hours, 9-13 hours post dose on Day 15; pre-dose and 1, 2, 3 hours post-dose on Day 29	Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of dapro. The data from each PK sampling day was combined to generate a single profile, and normalized to a 24-hour period to create a "Day 1" profile for non-compartmental analysis (NCA). Metabolite plasma concentrations were analyzed but PK parameters could not be calculated as the metabolites were partially eliminated through dialysis and the dialysis start and end times were not consistent on both PK days. Therefore, a representative metabolite PK profile could not be generated. The analysis was performed on PK Population, which comprised of all participants from whom a PK sample has been obtained and analyzed. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Secondary	Maximum Observed Concentration of Dapro in Plasma (Cmax)	Pre-dose on Day 1; 6-10 hours, 7-11 hours, 8-12 hours, 9-13 hours post dose on Day 15; pre-dose and 1, 2, 3 hours post-dose on Day 29	Blood samples were collected at indicated time points for PK analysis of dapro. The data from each PK sampling day was combined to generate a single profile, and normalized to a 24-hour period to create a "Day 1" profile for NCA. Metabolite plasma concentrations were analyzed but PK parameters could not be calculated as the metabolites were partially eliminated through dialysis and the dialysis start and end times were not consistent on both PK days. Therefore, a representative metabolite PK profile could not be generated.

1 to 10 of 40Source ClinicalTrials.gov

See all 40 registered outcomes

Outcomes40

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 Levels at Day 29	Baseline and Day 29	ITT Population	g/dL	MEAN
SECONDARY	Maximum Observed Change From Baseline in Plasma Erythropoietin (EPO)	Baseline and up to Day 29	ITT Population	International unit per liter (IU/L)	MEAN
SECONDARY	Maximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF)	Baseline and up to Day 29	ITT Population	Nanograms per liter (ng/L)	GEOMETRIC_MEAN
SECONDARY	Percent Change From Baseline in Hepcidin at Day 29	Baseline and Day 29	ITT Population	Micrograms per liter (µg/L)	GEOMETRIC_MEAN
SECONDARY	Change From Baseline in Hematocrit Levels	Baseline and Day 29	ITT Population	Proportion of red blood cells in blood	MEAN
SECONDARY	Change From Baseline in Red Blood Cell (RBC) Count	Baseline and Day 29	ITT Population	10^12 cells/L	MEAN
SECONDARY	Change From Baseline in Reticulocyte Count	Baseline and Day 29	ITT Population	Percentage of reticulocyte	MEAN
SECONDARY	Change From Baseline in Reticulocyte Hemoglobin (CHr)	Baseline and Day 29	ITT Population	Picograms (pg)	MEAN
SECONDARY	Area Under the Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) and AUC From Time Zero to Infinity (AUC[0-inf]) of Dapro	Pre-dose on Day 1; 6-10 hours, 7-11 hours, 8-12 hours, 9-13 hours post dose on Day 15; pre-dose and 1, 2, 3 hours post-dose on Day 29	PK Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	hour into nanograms/milliliter (h*ng/mL)	GEOMETRIC_MEAN
SECONDARY	Maximum Observed Concentration of Dapro in Plasma (Cmax)	Pre-dose on Day 1; 6-10 hours, 7-11 hours, 8-12 hours, 9-13 hours post dose on Day 15; pre-dose and 1, 2, 3 hours post-dose on Day 29	PK Population	ng/mL	GEOMETRIC_MEAN

1 to 10 of 40Source ClinicalTrials.gov

See all 40 outcomes

Results by group1,225

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

Outcome	Group	Value	Spread	Units
Change From Baseline in Hgb Levels at Day 29	Placebo	-0.61	Standard Deviation 0.646	g/dL
Change From Baseline in Hgb Levels at Day 29	Dapro 10 mg	-0.19	Standard Deviation 1.750	g/dL
Change From Baseline in Hgb Levels at Day 29	Dapro 15 mg	-0.13	Standard Deviation 1.088	g/dL
Change From Baseline in Hgb Levels at Day 29	Dapro 25 mg	0.64	Standard Deviation 1.453	g/dL
Change From Baseline in Hgb Levels at Day 29	Dapro 30 mg	0.55	Standard Deviation 1.167	g/dL
Maximum Observed Change From Baseline in Plasma Erythropoietin (EPO)	Placebo	53.761	Standard Deviation 132.6875	International unit per liter (IU/L)
Maximum Observed Change From Baseline in Plasma Erythropoietin (EPO)	Dapro 10 mg	2.255	Standard Deviation 84.8921	International unit per liter (IU/L)
Maximum Observed Change From Baseline in Plasma Erythropoietin (EPO)	Dapro 15 mg	73.369	Standard Deviation 95.9772	International unit per liter (IU/L)
Maximum Observed Change From Baseline in Plasma Erythropoietin (EPO)	Dapro 25 mg	302.529	Standard Deviation 469.8312	International unit per liter (IU/L)
Maximum Observed Change From Baseline in Plasma Erythropoietin (EPO)	Dapro 30 mg	477.644	Standard Deviation 388.9757	International unit per liter (IU/L)

1 to 10 of 1,225Source ClinicalTrials.gov

See all 1,225 results by group

Participant flow15

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	20
Overall Study	STARTED	Dapro 10 mg	20
Overall Study	STARTED	Dapro 15 mg	20
Overall Study	STARTED	Dapro 25 mg	21
Overall Study	STARTED	Dapro 30 mg	22
Overall Study	COMPLETED	Placebo	17
Overall Study	COMPLETED	Dapro 10 mg	19
Overall Study	COMPLETED	Dapro 15 mg	16
Overall Study	COMPLETED	Dapro 25 mg	17
Overall Study	COMPLETED	Dapro 30 mg	14

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events155

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	Bundle branch block left	Cardiac disorders	Placebo	0	19	0
other	Bundle branch block left	Cardiac disorders	Dapro 10 mg	0	20	0
other	Bundle branch block left	Cardiac disorders	Dapro 15 mg	1	20	1
other	Bundle branch block left	Cardiac disorders	Dapro 25 mg	0	22	0
other	Bundle branch block left	Cardiac disorders	Dapro 30 mg	0	22	0
other	Hyperparathyroidism	Endocrine disorders	Placebo	0	19	0
other	Hyperparathyroidism	Endocrine disorders	Dapro 10 mg	1	20	1
other	Hyperparathyroidism	Endocrine disorders	Dapro 15 mg	0	20	0
other	Hyperparathyroidism	Endocrine disorders	Dapro 25 mg	0	22	0
other	Hyperparathyroidism	Endocrine disorders	Dapro 30 mg	0	22	0

1 to 10 of 155Source ClinicalTrials.gov

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Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	19
Total, all-cause mortality	Dapro 10 mg	0	20
Total, all-cause mortality	Dapro 15 mg	0	20
Total, all-cause mortality	Dapro 25 mg	0	22
Total, all-cause mortality	Dapro 30 mg	0	22
Total, other adverse events	Placebo	5	19
Total, other adverse events	Dapro 10 mg	8	20
Total, other adverse events	Dapro 15 mg	4	20
Total, other adverse events	Dapro 25 mg	2	22
Total, other adverse events	Dapro 30 mg	0	22

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
31619187	BACKGROUND	PubMed
36005278	DERIVED	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.

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