Trial · NCT03799627
Study of Vadadustat in Hemodialysis Participants With Anemia Switching From Epoetin Alfa
NCT03799627, Phase 2, Completed, Akebia Therapeutics; results first posted 2022-09-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Vadadustat in Hemodialysis Participants With Anemia Switching From Epoetin Alfa. Trials, record NCT03799627. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03799627
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Vadadustat in Hemodialysis Participants With Anemia Switching From Epoetin Alfa
- NCT number
- NCT03799627
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 175 participants, actual
- Lead sponsor
- Akebia Therapeutics
- Conditions
- Anemia, Dialysis-dependent Chronic Kidney Disease
- Interventions
- Vadadustat, Epoetin Alfa, Vadadustat TIW
- First posted
- 2019-01-10
- Last updated
- 2022-09-29
- Results first posted
- 2022-09-29
- Limitations and caveats
Conclusions were drawn from results of the Main Study (n=165). As the sample size in the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study (n=10) was small in both the Vadadustat and Epoetin Alfa treatment groups, these results did not allow to meaningful interpretation of the data.
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Baseline; Week 10 to Week 12 | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. |
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to Week 24 | An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. |
| Primary | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Up to Week 24 | Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. |
| Primary | Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values | Up to Week 24 | Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. |
| Primary | Number of Participants Classified as Hb Outliers | Weeks 13 - 20 | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or \<8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. |
| Secondary | Number of Participants With Hb Values Within the Target Range at the PEP | Week 10 to Week 12 | The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. |
| Secondary | Mean Change in Hb From the PEP to the Secondary Evaluation Period (SEP) in Participants Who Transitioned to Three Times Per Week (TIW) Vadadustat Dosing After Week 12 | Week 10 to Week 12; Week 18 to Week 20 | Change from PEP was calculated as the SEP value minus the PEP value. The PEP value was the average Hb value from Week 10 to Week 12. The SEP value was the average Hb value from Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. |
| Secondary | Mean Change in Hb Between Baseline and the SEP | Baseline; Week 18 to Week 20 | Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. |
| Secondary | Number of Participants With Hb Values Within the Target Range at the SEP | Week 18 to Week 20 | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. |
| Secondary | Number of Participants With Hb Values Within the Target Range at the SEP in Participants Who Transitioned to TIW Vadadustat Dosing | Week 18 to Week 20 | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Baseline; Week 10 to Week 12 | Randomized Population: All randomized participants. Analysis of this population was based on the randomized treatment. | grams per deciliter (g/dL) | MEAN |
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to Week 24 | Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Up to Week 24 | Safety Population. Analysis of this population was based on the actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values | Up to Week 24 | Safety Population. Analysis of this population was based on the actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Classified as Hb Outliers | Weeks 13 - 20 | Safety Population. Analysis of this population was based on the actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. Only participants with available data were included in the analysis. The rows presenting data for HB \> 12.0 g/dL, HB \> 13.0 g/dL and HB \> 14.0 g/dL are mutually exclusive. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Hb Values Within the Target Range at the PEP | Week 10 to Week 12 | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change in Hb From the PEP to the Secondary Evaluation Period (SEP) in Participants Who Transitioned to Three Times Per Week (TIW) Vadadustat Dosing After Week 12 | Week 10 to Week 12; Week 18 to Week 20 | Randomized Population. Analysis of this population was based on the randomized treatment. Only those who switched from Vadadustat QD to TIW dosing after Week 12 were included in the analysis (17 participants overall in Main Study and 0 participants in ESA Hyporesponder Parallel Study). | g/dL | MEAN |
| SECONDARY | Mean Change in Hb Between Baseline and the SEP | Baseline; Week 18 to Week 20 | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | g/dL | MEAN |
| SECONDARY | Number of Participants With Hb Values Within the Target Range at the SEP | Week 18 to Week 20 | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Hb Values Within the Target Range at the SEP in Participants Who Transitioned to TIW Vadadustat Dosing | Week 18 to Week 20 | Randomized Population. Analysis of this population was based on the randomized treatment. Only those who switched from Vadadustat QD to TIW dosing after Week 12 were included in the analysis (17 participants overall in Main Study and 0 participants in ESA Hyporesponder Parallel Study). | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group597
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Low Dose of Epoetin Alfa: Vadadustat 300 mg | Baseline | 10.223 | Standard Deviation 0.5805 | grams per deciliter (g/dL) |
| Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Low Dose of Epoetin Alfa: Vadadustat 450 mg | Baseline | 10.059 | Standard Deviation 0.6769 | grams per deciliter (g/dL) |
| Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Low Dose of Epoetin Alfa: Epoetin Alfa | Baseline | 10.165 | Standard Deviation 0.6806 | grams per deciliter (g/dL) |
| Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | High Dose of Epoetin Alfa: Vadadustat 300 mg | Baseline | 9.778 | Standard Deviation 0.6832 | grams per deciliter (g/dL) |
| Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | High Dose of Epoetin Alfa: Vadadustat 450 mg | Baseline | 10.288 | Standard Deviation 0.5445 | grams per deciliter (g/dL) |
| Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | High Dose of Epoetin Alfa: Vadadustat 600 mg | Baseline | 10.095 | Standard Deviation 0.7150 | grams per deciliter (g/dL) |
| Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | High Dose of Epoetin Alfa: Epoetin Alfa | Baseline | 9.950 | Standard Deviation 0.7950 | grams per deciliter (g/dL) |
| Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | ESA Hyporesponder: Vadadustat 600 mg | Baseline | 9.530 | Standard Deviation 0.2864 | grams per deciliter (g/dL) |
| Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | ESA Hyporesponder: Epoetin Alfa | Baseline | 9.620 | Standard Deviation 0.6925 | grams per deciliter (g/dL) |
| Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Low Dose of Epoetin Alfa: Vadadustat 300 mg | Change from Baseline at PEP | -0.371 | Standard Deviation 0.8920 | grams per deciliter (g/dL) |
1 to 10 of 597Source ClinicalTrials.gov
See all 597 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Low Dose of Epoetin Alfa: Vadadustat 300 mg | 35 | |
| Overall Study | STARTED | Low Dose of Epoetin Alfa: Vadadustat 450 mg | 34 | |
| Overall Study | STARTED | Low Dose of Epoetin Alfa: Epoetin Alfa | 23 | |
| Overall Study | STARTED | High Dose of Epoetin Alfa: Vadadustat 300 mg | 18 | |
| Overall Study | STARTED | High Dose of Epoetin Alfa: Vadadustat 450 mg | 21 | |
| Overall Study | STARTED | High Dose of Epoetin Alfa: Vadadustat 600 mg | 21 | |
| Overall Study | STARTED | High Dose of Epoetin Alfa: Epoetin Alfa | 13 | |
| Overall Study | STARTED | ESA Hyporesponder: Vadadustat 600 mg | 5 | |
| Overall Study | STARTED | ESA Hyporesponder: Epoetin Alfa | 5 | |
| Overall Study | COMPLETED | Low Dose of Epoetin Alfa: Vadadustat 300 mg | 27 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events1,395
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 | Low Dose of Epoetin Alfa: Vadadustat 300 mg | 0 | 34 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Low Dose of Epoetin Alfa: Vadadustat 450 mg | 0 | 35 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Low Dose of Epoetin Alfa: Epoetin Alfa | 0 | 23 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | High Dose of Epoetin Alfa: Vadadustat 300 mg | 1 | 18 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | High Dose of Epoetin Alfa: Vadadustat 450 mg | 0 | 21 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | High Dose of Epoetin Alfa: Vadadustat 600 mg | 1 | 21 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | High Dose of Epoetin Alfa: Epoetin Alfa | 0 | 13 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | ESA Hyporesponder: Vadadustat 600 mg | 1 | 5 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | ESA Hyporesponder: Epoetin Alfa | 0 | 5 | 0 |
| other | Nephrogenic anaemia | Blood and lymphatic system disorders | Low Dose of Epoetin Alfa: Vadadustat 300 mg | 0 | 34 | 0 |
1 to 10 of 1,395Source ClinicalTrials.gov
See all 1,395 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Low Dose of Epoetin Alfa: Vadadustat 300 mg | 0 | 34 |
| Total, all-cause mortality | Low Dose of Epoetin Alfa: Vadadustat 450 mg | 0 | 35 |
| Total, all-cause mortality | Low Dose of Epoetin Alfa: Epoetin Alfa | 0 | 23 |
| Total, all-cause mortality | High Dose of Epoetin Alfa: Vadadustat 300 mg | 1 | 18 |
| Total, all-cause mortality | High Dose of Epoetin Alfa: Vadadustat 450 mg | 1 | 21 |
| Total, all-cause mortality | High Dose of Epoetin Alfa: Vadadustat 600 mg | 1 | 21 |
| Total, all-cause mortality | High Dose of Epoetin Alfa: Epoetin Alfa | 1 | 13 |
| Total, all-cause mortality | ESA Hyporesponder: Vadadustat 600 mg | 0 | 5 |
| Total, all-cause mortality | ESA Hyporesponder: Epoetin Alfa | 0 | 5 |
| Total, other adverse events | Low Dose of Epoetin Alfa: Vadadustat 300 mg | 11 | 34 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36005278 | DERIVED |
Source 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.
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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