Trial · NCT03140722
Study to Evaluate Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents
NCT03140722, Phase 2, Terminated, Akebia Therapeutics; results first posted 2021-02-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents. Trials, record NCT03140722. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03140722
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents
- NCT number
- NCT03140722
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 2 participants, actual
- Lead sponsor
- Akebia Therapeutics
- Conditions
- Anemia, Dialysis-Dependent Chronic Kidney Disease
- Interventions
- vadadustat, epoetin alfa
- First posted
- 2017-05-04
- Last updated
- 2021-02-21
- Results first posted
- 2021-02-21
- Limitations and caveats
The Study was closed by the Sponsor as it was determined that it was more appropriate to initiate a new study that would explore the broader population utilizing a modified dosing approach (rather than amending the current protocol design).
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Hemoglobin (Hb) Over Time During the Treatment Period | Baseline; up to 20 weeks | |
| Secondary | Number of Participants Demonstrating Incremental Increases in Hb From Baseline Over Time During the Treatment Period | Baseline; up to 20 weeks | |
| Secondary | Number of Participants With Hb Values Within the Target Range of 10.0-11.0 Grams Per Deciliter (g/dL) During the Treatment Period | Baseline; up to 20 weeks | |
| Secondary | Number of Participants Receiving Epoetin Alfa Rescue | up to 20 weeks | |
| Secondary | Number of Participants Receiving Red Blood Cell Transfusion | up to 20 weeks | |
| Secondary | Number of Participants With Specified Levels of Various Biomarkers, Including C-reactive Protein, Hepcidin, and Vascular Endothelial Growth Factor | up to 20 weeks | |
| Secondary | Mean Weekly Dose of Intravenous Elemental Iron Administered | up to 20 weeks | |
| Secondary | Number of Participants Maintaining Iron Sufficiency (Defined as Ferritin ≥100 Nanograms Per Milliliter and Transferrin Saturation ≥20%) | up to 20 weeks | |
| Secondary | Number of Participants Utilizing Resources | up to 20 weeks | |
| Secondary | Number of Participants With Treatment-emergent Adverse Events | up to 24 weeks | Treatment-emergent adverse events were collected in all participants enrolled in the study. |
Source ClinicalTrials.gov
Outcomes10
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) Over Time During the Treatment Period | Baseline; up to 20 weeks | No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=2). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. | ||
| SECONDARY | Number of Participants Demonstrating Incremental Increases in Hb From Baseline Over Time During the Treatment Period | Baseline; up to 20 weeks | No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=2). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. | ||
| SECONDARY | Number of Participants With Hb Values Within the Target Range of 10.0-11.0 Grams Per Deciliter (g/dL) During the Treatment Period | Baseline; up to 20 weeks | No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=2). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. | ||
| SECONDARY | Number of Participants Receiving Epoetin Alfa Rescue | up to 20 weeks | No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=2). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. | ||
| SECONDARY | Number of Participants Receiving Red Blood Cell Transfusion | up to 20 weeks | No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=2). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. | ||
| SECONDARY | Number of Participants With Specified Levels of Various Biomarkers, Including C-reactive Protein, Hepcidin, and Vascular Endothelial Growth Factor | up to 20 weeks | No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=2). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. | ||
| SECONDARY | Mean Weekly Dose of Intravenous Elemental Iron Administered | up to 20 weeks | No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=2). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. | ||
| SECONDARY | Number of Participants Maintaining Iron Sufficiency (Defined as Ferritin ≥100 Nanograms Per Milliliter and Transferrin Saturation ≥20%) | up to 20 weeks | No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=2). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. | ||
| SECONDARY | Number of Participants Utilizing Resources | up to 20 weeks | No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=2). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. | ||
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events | up to 24 weeks | All participants enrolled in the study | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events | Vadadustat | 0 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events | Epoetin Alfa | 0 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vadadustat | 0 | |
| Overall Study | STARTED | Epoetin Alfa | 2 | |
| Overall Study | COMPLETED | Vadadustat | 0 | |
| Overall Study | COMPLETED | Epoetin Alfa | 2 | |
| Overall Study | NOT COMPLETED | Vadadustat | 0 | |
| Overall Study | NOT COMPLETED | Epoetin Alfa | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vadadustat | 0 | 0 |
| Total, all-cause mortality | Epoetin Alfa | 0 | 2 |
| Total, other adverse events | Vadadustat | 0 | 0 |
| Total, other adverse events | Epoetin Alfa | 0 | 2 |
| Total, serious adverse events | Vadadustat | 0 | 0 |
| Total, serious adverse events | Epoetin Alfa | 0 | 2 |
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.
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/NCT03140722
GET https://conductscience.org/api/trials/v1/NCT03140722/registered