Trial · NCT04707768

Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects

NCT04707768, Phase 3, Completed, Akebia Therapeutics; results first posted 2025-01-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects. Trials, record NCT04707768. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04707768

On this page

Trial

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

Title: Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects
NCT number: NCT04707768
Status: Completed
Phases: Phase 3
Enrollment: 456 participants, actual
Lead sponsor: Akebia Therapeutics
Conditions: Anemia Associated With Chronic Kidney Disease (CKD)
Interventions: Vadadustat, Mircera®
First posted: 2021-01-13
Last updated: 2025-01-15
Results first posted: 2025-01-15

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Evaluation Period (PEP) (Weeks 20 to 26)	Baseline; Weeks 20 to 26	The Baseline Hb was defined as the average of last 2 central laboratory Hb measurements of samples taken at or prior to the first dose. The average for the PEP was calculated as the average of all Hb measurements from the central laboratory within the three visit windows during Weeks 20 through 26. Analysis was conducted using an analysis of covariance (ANCOVA) model with multiple imputation for missing data with randomization stratification factors and Baseline Hb as covariates. Change from Baseline was calculated as PEP value minus the Baseline value.
Secondary	Change From Baseline in Hb to the Average Over the Secondary Evaluation Period (SEP) (Weeks 46 to 52)	Baseline; Weeks 46 to 52	The Baseline Hb was defined as the average of the last 2 central laboratory Hb values taken on or prior to the first dose date. The average for the SEP was calculated as the average of all Hb measurements from the central laboratory within the three visit windows during Weeks 46 through 52. Analysis was conducted using an ANCOVA model with multiple imputation for missing data with randomization stratification factors and Baseline Hb as covariates. Change from Baseline was calculated as SEP value minus the Baseline value.

Source ClinicalTrials.gov

Outcomes2

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 Hemoglobin (Hb) to the Average Over the Primary Evaluation Period (PEP) (Weeks 20 to 26)	Baseline; Weeks 20 to 26	Randomized Population	Grams per deciliter (g/dL)	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Hb to the Average Over the Secondary Evaluation Period (SEP) (Weeks 46 to 52)	Baseline; Weeks 46 to 52	Randomized population.	Grams per deciliter	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Value	Spread	Units
Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Evaluation Period (PEP) (Weeks 20 to 26)	Vadadustat 600 mg TIW	-0.07	Standard Error 0.095	Grams per deciliter (g/dL)
Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Evaluation Period (PEP) (Weeks 20 to 26)	Vadadustat 900 mg TIW	0.14	Standard Error 0.095	Grams per deciliter (g/dL)
Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Evaluation Period (PEP) (Weeks 20 to 26)	Mircera®	0.36	Standard Error 0.092	Grams per deciliter (g/dL)
Change From Baseline in Hb to the Average Over the Secondary Evaluation Period (SEP) (Weeks 46 to 52)	Vadadustat 600 mg TIW	-0.11	Standard Error 0.110	Grams per deciliter
Change From Baseline in Hb to the Average Over the Secondary Evaluation Period (SEP) (Weeks 46 to 52)	Vadadustat 900 mg TIW	-0.22	Standard Error 0.123	Grams per deciliter
Change From Baseline in Hb to the Average Over the Secondary Evaluation Period (SEP) (Weeks 46 to 52)	Mircera®	0.16	Standard Error 0.102	Grams per deciliter

Source ClinicalTrials.gov

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Vadadustat 600 mg TIW	152
Overall Study	STARTED	Vadadustat 900 mg TIW	152
Overall Study	STARTED	Mircera®	152
Overall Study	COMPLETED	Vadadustat 600 mg TIW	99
Overall Study	COMPLETED	Vadadustat 900 mg TIW	98
Overall Study	COMPLETED	Mircera®	118
Overall Study	NOT COMPLETED	Vadadustat 600 mg TIW	53
Overall Study	NOT COMPLETED	Vadadustat 900 mg TIW	54
Overall Study	NOT COMPLETED	Mircera®	34

Source ClinicalTrials.gov

Adverse events624

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
other	COVID 19	Infections and infestations	Vadadustat 600 mg TIW	19	151
other	COVID 19	Infections and infestations	Vadadustat 900 mg TIW	18	150
other	COVID 19	Infections and infestations	Mircera®	19	150
other	Diarrhoea	Gastrointestinal disorders	Vadadustat 600 mg TIW	16	151
other	Diarrhoea	Gastrointestinal disorders	Vadadustat 900 mg TIW	21	150
other	Diarrhoea	Gastrointestinal disorders	Mircera®	11	150
other	Nausea	Gastrointestinal disorders	Vadadustat 600 mg TIW	12	151
other	Nausea	Gastrointestinal disorders	Vadadustat 900 mg TIW	13	150
other	Nausea	Gastrointestinal disorders	Mircera®	7	150
other	Hyperkalaemia	Metabolism and nutrition disorders	Vadadustat 600 mg TIW	6	151

1 to 10 of 624Source ClinicalTrials.gov

See all 624 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Vadadustat 600 mg TIW	14	151
Total, all-cause mortality	Vadadustat 900 mg TIW	12	150
Total, all-cause mortality	Mircera®	17	150
Total, other adverse events	Vadadustat 600 mg TIW	61	151
Total, other adverse events	Vadadustat 900 mg TIW	67	150
Total, other adverse events	Mircera®	64	150
Total, serious adverse events	Vadadustat 600 mg TIW	68	151
Total, serious adverse events	Vadadustat 900 mg TIW	66	150
Total, serious adverse events	Mircera®	67	150

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
39231617	DERIVED	PubMed
39521398	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.

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/NCT04707768

GET https://conductscience.org/api/trials/v1/NCT04707768/events?page=2

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