Trial · NCT02260193

16-Week Repeat Oral Dose Study of AKB-6548 for Anemia in Participants With End Stage Renal Disease (ESRD) Requiring Chronic Hemodialysis

NCT02260193, Phase 2, Completed, Akebia Therapeutics; results first posted 2022-07-01

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. 16-Week Repeat Oral Dose Study of AKB-6548 for Anemia in Participants With End Stage Renal Disease (ESRD) Requiring Chronic Hemodialysis. Trials, record NCT02260193. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02260193

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Trial

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

Title: 16-Week Repeat Oral Dose Study of AKB-6548 for Anemia in Participants With End Stage Renal Disease (ESRD) Requiring Chronic Hemodialysis
NCT number: NCT02260193
Status: Completed
Phases: Phase 2
Enrollment: 94 participants, actual
Lead sponsor: Akebia Therapeutics
Conditions: Anemia, End Stage Renal Disease
Interventions: AKB-6548, AKB-6548, AKB-6548
First posted: 2014-10-09
Last updated: 2022-07-01
Results first posted: 2022-07-01

Source ClinicalTrials.gov

Registered outcomes24

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

List	Outcome	Time frame	Description
Primary	Change From Pre-dose Average in Hemoglobin (Hgb) Level to The Mid-study Average	Pre-dose (Screening, Second Screening, and Baseline), Week 7, and Week 8	Change from pre-dose average was calculated by the mid-study average minus the pre-dose average. The pre-dose average was defined as the average of the 3 Hgb values that were obtained before dosing at the first screening visit, the second screening visit, and the Baseline visit; the mid-study average was defined as the average of the 2 Hgb values that were obtained at the Week 7 and Week 8 visits.
Primary	Change From Pre-dose Average in Hgb Level to The End-of-study Average	Pre-dose, Week 15, and Week 16	Change from pre-dose average was calculated by the end-of-study average minus the pre-dose average. The pre-dose average was defined as the average of the 3 Hgb values that were obtained before dosing at the first screening visit, the second screening visit, and the Baseline visit; the end-of-study average was defined as the average of the 2 Hgb values that were obtained at the Week 15 and Week 16 visits.
Primary	Change From Mid-study Average in Hgb Level to The End-of-study Average	Week 7, Week 8, Week 15, and Week 16	Change from mid-study average was calculated by the end-of-study average minus the mid-study average. The mid-study average was defined as the average of the 2 Hgb values that were obtained at the Week 7 and Week 8 visits; the end-of-study average was defined as the average of the 2 Hgb values that were obtained at the Week 15 and Week 16 visits.
Secondary	Change From Baseline in Hgb	Baseline, Week 4, Week 8, Week 12, and Week 16	Change from Baseline was calculated as the visit value minus the Baseline value. Baseline Hgb was defined as the average of the three samples obtained prior to dosing.
Secondary	Change From Baseline in Hematocrit	Baseline, Week 4, Week 8, Week 12, and Week 16	Change from Baseline was calculated as the visit value minus the Baseline value. Baseline Hematocrit was defined as the last observation before the first dose of study medication.
Secondary	Change From Baseline in Red Blood Cell (RBC) Count	Baseline, Week 4, Week 8, Week 12, and Week 16	Change from Baseline was calculated as the visit value minus the Baseline value. Baseline RBC Count was defined as the average of the three samples obtained prior to dosing.
Secondary	Change From Baseline in Absolute Reticulocyte Count	Baseline, Week 4, Week 8, Week 12, and Week 16	Change from Baseline was calculated as the visit value minus the Baseline value. Baseline absolute reticulocyte count was defined as the last observation before the first dose of study medication.
Secondary	Change From Baseline in Percent Reticulocyte Count	Baseline, Week 4, Week 8, Week 12, and Week 16	Change from Baseline was calculated as (visit value minus the Baseline value)/ Baseline value x 100. Baseline percent reticulocyte count was defined as the last observation before the first dose of study medication.
Secondary	Change From Baseline in Reticulocyte Hgb Content	Baseline, Week 2, Week 4, Week 8, and Week 16	Change from Baseline was calculated as the visit value minus the Baseline value. Baseline reticulocyte Hgb content was defined as the average of the three samples obtained prior to dosing.
Secondary	Change From Baseline in Ferritin	Baseline, Week 4, Week 8, Week 12, and Week 16	Change from Baseline was calculated as the visit value minus the Baseline value. Baseline ferritin was defined as the last observation before the first dose of study medication.

1 to 10 of 24Source ClinicalTrials.gov

See all 24 registered outcomes

Outcomes24

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Pre-dose Average in Hemoglobin (Hgb) Level to The Mid-study Average	Pre-dose (Screening, Second Screening, and Baseline), Week 7, and Week 8	Modified Intent-to-treat (MITT) Population: All participants who were assigned to study medication, received at least 1 dose of study medication, and had a pre-dose average and at least one post-baseline Hgb measurement. The primary analysis was performed in the MITT population using observed Hgb data without imputation for missing data.	Grams per deciliter (g/dL)	MEAN
PRIMARY	Change From Pre-dose Average in Hgb Level to The End-of-study Average	Pre-dose, Week 15, and Week 16	MITT Population. The primary analysis was performed in the MITT population using observed Hgb data without imputation for missing data.	g/dL	MEAN
PRIMARY	Change From Mid-study Average in Hgb Level to The End-of-study Average	Week 7, Week 8, Week 15, and Week 16	MITT Population. The primary analysis was performed in the MITT population using observed Hgb data without imputation for missing data.	g/dL	MEAN
SECONDARY	Change From Baseline in Hgb	Baseline, Week 4, Week 8, Week 12, and Week 16	MITT Population	g/dL	MEAN
SECONDARY	Change From Baseline in Hematocrit	Baseline, Week 4, Week 8, Week 12, and Week 16	MITT Population	Percentage of red blood cells in blood	MEAN
SECONDARY	Change From Baseline in Red Blood Cell (RBC) Count	Baseline, Week 4, Week 8, Week 12, and Week 16	MITT Population	10^6 cells per microliter	MEAN
SECONDARY	Change From Baseline in Absolute Reticulocyte Count	Baseline, Week 4, Week 8, Week 12, and Week 16	MITT Population	10^6 cells per microliter	MEAN
SECONDARY	Change From Baseline in Percent Reticulocyte Count	Baseline, Week 4, Week 8, Week 12, and Week 16	MITT Population	Percent change	MEAN
SECONDARY	Change From Baseline in Reticulocyte Hgb Content	Baseline, Week 2, Week 4, Week 8, and Week 16	MITT Population	μg/dL	MEAN
SECONDARY	Change From Baseline in Ferritin	Baseline, Week 4, Week 8, Week 12, and Week 16	MITT Population	Nanograms per milliliter (ng/mL)	MEAN

1 to 10 of 24Source ClinicalTrials.gov

See all 24 outcomes

Results by group231

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

Outcome	Group	Category	Value	Spread	Units
Change From Pre-dose Average in Hemoglobin (Hgb) Level to The Mid-study Average	Vadadustat 300 mg Once Daily (QD)	Pre-dose Average	10.43	Standard Deviation 0.645	Grams per deciliter (g/dL)
Change From Pre-dose Average in Hemoglobin (Hgb) Level to The Mid-study Average	Vadadustat 450 mg QD	Pre-dose Average	10.55	Standard Deviation 0.577	Grams per deciliter (g/dL)
Change From Pre-dose Average in Hemoglobin (Hgb) Level to The Mid-study Average	Vadadustat 450 mg 3 Times Per Week (TIW)	Pre-dose Average	10.52	Standard Deviation 0.534	Grams per deciliter (g/dL)
Change From Pre-dose Average in Hemoglobin (Hgb) Level to The Mid-study Average	Vadadustat 300 mg Once Daily (QD)	Change from pre-dose average to the mid-study average	0.00	Standard Deviation 0.897	Grams per deciliter (g/dL)
Change From Pre-dose Average in Hemoglobin (Hgb) Level to The Mid-study Average	Vadadustat 450 mg QD	Change from pre-dose average to the mid-study average	-0.29	Standard Deviation 0.970	Grams per deciliter (g/dL)
Change From Pre-dose Average in Hemoglobin (Hgb) Level to The Mid-study Average	Vadadustat 450 mg 3 Times Per Week (TIW)	Change from pre-dose average to the mid-study average	-0.36	Standard Deviation 1.134	Grams per deciliter (g/dL)
Change From Pre-dose Average in Hgb Level to The End-of-study Average	Vadadustat 300 mg Once Daily (QD)	Pre-dose Average	10.43	Standard Deviation 0.645	g/dL
Change From Pre-dose Average in Hgb Level to The End-of-study Average	Vadadustat 450 mg QD	Pre-dose Average	10.55	Standard Deviation 0.577	g/dL
Change From Pre-dose Average in Hgb Level to The End-of-study Average	Vadadustat 450 mg 3 Times Per Week (TIW)	Pre-dose Average	10.52	Standard Deviation 0.534	g/dL
Change From Pre-dose Average in Hgb Level to The End-of-study Average	Vadadustat 300 mg Once Daily (QD)	Change From Pre-dose average to The End-of-study Average	-0.03	Standard Deviation 0.902	g/dL

1 to 10 of 231Source ClinicalTrials.gov

See all 231 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Vadadustat 300 mg Once Daily (QD)	30
Overall Study	STARTED	Vadadustat 450 mg QD	33
Overall Study	STARTED	Vadadustat 450 mg 3 Times Per Week (TIW)	31
Overall Study	COMPLETED	Vadadustat 300 mg Once Daily (QD)	24
Overall Study	COMPLETED	Vadadustat 450 mg QD	24
Overall Study	COMPLETED	Vadadustat 450 mg 3 Times Per Week (TIW)	21
Overall Study	NOT COMPLETED	Vadadustat 300 mg Once Daily (QD)	6
Overall Study	NOT COMPLETED	Vadadustat 450 mg QD	9
Overall Study	NOT COMPLETED	Vadadustat 450 mg 3 Times Per Week (TIW)	10

Source ClinicalTrials.gov

Adverse events159

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	Hyperparathyroidism secondary	Endocrine disorders	Vadadustat 300 mg Once Daily (QD)	0	30	0
other	Hyperparathyroidism secondary	Endocrine disorders	Vadadustat 450 mg QD	0	33	0
other	Hyperparathyroidism secondary	Endocrine disorders	Vadadustat 450 mg 3 Times Per Week (TIW)	3	31	3
other	Eye pain	Eye disorders	Vadadustat 300 mg Once Daily (QD)	0	30	0
other	Eye pain	Eye disorders	Vadadustat 450 mg QD	0	33	0
other	Eye pain	Eye disorders	Vadadustat 450 mg 3 Times Per Week (TIW)	2	31	2
other	Abdominal pain	Gastrointestinal disorders	Vadadustat 300 mg Once Daily (QD)	2	30	2
other	Abdominal pain	Gastrointestinal disorders	Vadadustat 450 mg QD	4	33	4
other	Abdominal pain	Gastrointestinal disorders	Vadadustat 450 mg 3 Times Per Week (TIW)	0	31	0
other	Abdominal pain upper	Gastrointestinal disorders	Vadadustat 300 mg Once Daily (QD)	0	30	0

1 to 10 of 159Source ClinicalTrials.gov

See all 159 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Vadadustat 300 mg Once Daily (QD)	0	30
Total, all-cause mortality	Vadadustat 450 mg QD	0	33
Total, all-cause mortality	Vadadustat 450 mg 3 Times Per Week (TIW)	0	31
Total, other adverse events	Vadadustat 300 mg Once Daily (QD)	22	30
Total, other adverse events	Vadadustat 450 mg QD	19	33
Total, other adverse events	Vadadustat 450 mg 3 Times Per Week (TIW)	23	31
Total, serious adverse events	Vadadustat 300 mg Once Daily (QD)	5	30
Total, serious adverse events	Vadadustat 450 mg QD	9	33
Total, serious adverse events	Vadadustat 450 mg 3 Times Per Week (TIW)	8	31

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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/NCT02260193

GET https://conductscience.org/api/trials/v1/NCT02260193/registered?page=2

API reference For AI assistants