Trial · NCT04313153
Trial Evaluating the Efficacy and Safety of Oral Vadadustat Once Daily (QD) and Three Times Weekly (TIW) for the Maintenance Treatment of Anemia in Hemodialysis Subjects Converting From Erythropoiesis-Stimulating Agents (ESAs)
NCT04313153, Phase 3, Completed, Akebia Therapeutics; results first posted 2025-05-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial Evaluating the Efficacy and Safety of Oral Vadadustat Once Daily (QD) and Three Times Weekly (TIW) for the Maintenance Treatment of Anemia in Hemodialysis Subjects Converting From Erythropoiesis-Stimulating Agents (ESAs). Trials, record NCT04313153. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04313153
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Trial Evaluating the Efficacy and Safety of Oral Vadadustat Once Daily (QD) and Three Times Weekly (TIW) for the Maintenance Treatment of Anemia in Hemodialysis Subjects Converting From Erythropoiesis-Stimulating Agents (ESAs)
- NCT number
- NCT04313153
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 319 participants, actual
- Lead sponsor
- Akebia Therapeutics
- Conditions
- Anemia
- Interventions
- Vadadustat, Darbepoetin alfa
- First posted
- 2020-03-18
- Last updated
- 2025-05-22
- Other registries' IDs
- eudract:2019-004851-36
- Results first posted
- 2025-05-22
- Limitations and caveats
- Per the protocol, data was collected by the arm to which participants were randomized and not by dose received in vadadustat QD or vadadustat TIW arms.
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 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 the last 2 central laboratory Hb values taken on or prior to the first dose date. 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, regardless of intercurrent events. 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, regardless of intercurrent events. 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 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 | g/dL | 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 | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Hb to the Average Over the Primary Evaluation Period (PEP) (Weeks 20 to 26) | Vadadustat QD | 0.07 | Standard Error 0.12 | Grams per deciliter (g/dL) | |
| Change From Baseline in Hb to the Average Over the Primary Evaluation Period (PEP) (Weeks 20 to 26) | Vadadustat TIW | -0.19 | Standard Error 0.12 | Grams per deciliter (g/dL) | |
| Change From Baseline in Hb to the Average Over the Primary Evaluation Period (PEP) (Weeks 20 to 26) | Darbepoetin Alfa | 0.34 | Standard Error 0.12 | Grams per deciliter (g/dL) | |
| Change From Baseline in Hb to the Average Over the Secondary Evaluation Period (SEP) (Weeks 46 to 52) | Vadadustat QD | 0.04 | Standard Error 0.15 | g/dL | |
| Change From Baseline in Hb to the Average Over the Secondary Evaluation Period (SEP) (Weeks 46 to 52) | Vadadustat TIW | 0.03 | Standard Error 0.15 | g/dL | |
| Change From Baseline in Hb to the Average Over the Secondary Evaluation Period (SEP) (Weeks 46 to 52) | Darbepoetin Alfa | 0.44 | Standard Error 0.15 | g/dL |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vadadustat QD | 105 | |
| Overall Study | STARTED | Vadadustat TIW | 106 | |
| Overall Study | STARTED | Darbepoetin Alfa | 108 | |
| Overall Study | COMPLETED | Vadadustat QD | 54 | |
| Overall Study | COMPLETED | Vadadustat TIW | 50 | |
| Overall Study | COMPLETED | Darbepoetin Alfa | 67 | |
| Overall Study | NOT COMPLETED | Vadadustat QD | 51 | |
| Overall Study | NOT COMPLETED | Vadadustat TIW | 56 | |
| Overall Study | NOT COMPLETED | Darbepoetin Alfa | 41 |
Source ClinicalTrials.gov
Adverse events501
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 | Anaemia | Blood and lymphatic system disorders | Vadadustat QD | 5 | 105 | |
| other | Anaemia | Blood and lymphatic system disorders | Vadadustat TIW | 7 | 104 | |
| other | Anaemia | Blood and lymphatic system disorders | Darbepoetin Alfa | 7 | 108 | |
| other | Abdominal pain | Gastrointestinal disorders | Vadadustat QD | 4 | 105 | |
| other | Abdominal pain | Gastrointestinal disorders | Vadadustat TIW | 4 | 104 | |
| other | Abdominal pain | Gastrointestinal disorders | Darbepoetin Alfa | 8 | 108 | |
| other | Diarrhoea | Gastrointestinal disorders | Vadadustat QD | 14 | 105 | |
| other | Diarrhoea | Gastrointestinal disorders | Vadadustat TIW | 15 | 104 | |
| other | Diarrhoea | Gastrointestinal disorders | Darbepoetin Alfa | 6 | 108 | |
| other | Nausea | Gastrointestinal disorders | Vadadustat QD | 12 | 105 |
1 to 10 of 501Source ClinicalTrials.gov
See all 501 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vadadustat QD | 12 | 105 |
| Total, all-cause mortality | Vadadustat TIW | 9 | 104 |
| Total, all-cause mortality | Darbepoetin Alfa | 7 | 108 |
| Total, other adverse events | Vadadustat QD | 46 | 105 |
| Total, other adverse events | Vadadustat TIW | 49 | 104 |
| Total, other adverse events | Darbepoetin Alfa | 46 | 108 |
| Total, serious adverse events | Vadadustat QD | 47 | 105 |
| Total, serious adverse events | Vadadustat TIW | 47 | 104 |
| Total, serious adverse events | Darbepoetin Alfa | 47 | 108 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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.
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/NCT04313153
GET https://conductscience.org/api/trials/v1/NCT04313153/events?page=2