Trial · NCT03054350
Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Dialysis-Dependent Chronic Kidney Disease (DD-CKD)
NCT03054350, Phase 2, Completed, Akebia Therapeutics; results first posted 2021-04-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Dialysis-Dependent Chronic Kidney Disease (DD-CKD). Trials, record NCT03054350. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03054350
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Dialysis-Dependent Chronic Kidney Disease (DD-CKD)
- NCT number
- NCT03054350
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 60 participants, actual
- Lead sponsor
- Akebia Therapeutics
- Conditions
- Anemia, Dialysis Dependent Chronic Kidney Disease
- Interventions
- Vadadustat, Placebo
- First posted
- 2017-02-15
- Last updated
- 2021-04-08
- Results first posted
- 2021-04-08
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in Hemoglobin (Hb) Levels From Pre-treatment to the End of the Primary Efficacy Period | Pre-treatment; Week 6 | The pre-treatment average value for Hb was defined as the average of 3 values obtained prior to treatment, i.e., the qualifying screening value and the Baseline value. Change from Pre-treatment was calculated as the Week 6 value minus the Pre-treatment value. |
| Secondary | Time to Reach the Target Hb Level of 10.0 to 12.0 g/dL From Baseline up to Week 16 | from Baseline up to Week 16 | Time for this analysis was measured from Day 1 (Baseline) through the point in time during either the Primary Efficacy Period or the Dose Adjustment and Maintenance Period when a participant's Hb level achieved the target range of 10.0 to 12.0 g/dL. |
| Secondary | Mean Hb Levels at the End of the Primary Efficacy Period | up to Week 6 | Data are reported as mean of the actual Week 6 values. |
| Secondary | Mean Hb Levels at the End of the Dose Adjustment and Maintenance Period | up to Week 16 | Data are reported as mean of the actual Week 16 values. |
| Secondary | Number of Participants Who Achieved the Target Hb Level of 10.0 to 12.0 g/dL at the End of the Dose Adjustment and Maintenance Period | up to Week 16 | |
| Secondary | Mean Change in Hb Between Pre-treatment and the End of the Dose Adjustment and Maintenance Period | Pre-treatment; Week 16 | A pre-treatment average value for Hb was defined as the average of 3 values obtained prior to dosing, i.e., the 2 qualifying screening values and the Baseline value. Change from Pre-treatment was calculated as the Week 16 value minus the Pre-treatment value. |
| Secondary | Mean Change in Red Blood Cell (RBC) Count and Absolute Reticulocyte Count From Baseline to the End of the Primary Efficacy Period | Baseline; Week 6 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Mean Change in RBC Count and Absolute Reticulocyte Count From Baseline to the End of the Dose Adjustment and Maintenance Period | Baseline; Week 16 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Mean Change in Hematocrit and Reticulocytes From Baseline to the End of the Primary Efficacy Period | Baseline; Week 6 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Mean Change in Hematocrit and Reticulocytes From Baseline to the End of the Dose Adjustment and Maintenance Period | Baseline; Week 16 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
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) Levels From Pre-treatment to the End of the Primary Efficacy Period | Pre-treatment; Week 6 | Modified Intent-to-Treat Population (mITT): all randomized participants who received at least 1 dose of study medication, had a pre-treatment Hb average, and at least one post-Baseline Hb measurement. The mITT Population was based on the treatment to which participants were randomized. | grams per deciliter (g/dL) | LEAST_SQUARES_MEAN |
| SECONDARY | Time to Reach the Target Hb Level of 10.0 to 12.0 g/dL From Baseline up to Week 16 | from Baseline up to Week 16 | mITT Population. Only participants with Hb \< 10.0 g/dL at the Baseline visit were included in the analysis. | days | MEAN |
| SECONDARY | Mean Hb Levels at the End of the Primary Efficacy Period | up to Week 6 | mITT Population. Only participants with available data were analyzed. | g/dL | MEAN |
| SECONDARY | Mean Hb Levels at the End of the Dose Adjustment and Maintenance Period | up to Week 16 | mITT Population. Only participants with available data were analyzed. | g/dL | MEAN |
| SECONDARY | Number of Participants Who Achieved the Target Hb Level of 10.0 to 12.0 g/dL at the End of the Dose Adjustment and Maintenance Period | up to Week 16 | mITT Population. Only participants with available data were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change in Hb Between Pre-treatment and the End of the Dose Adjustment and Maintenance Period | Pre-treatment; Week 16 | mITT Population. Only participants with available data were analyzed. | g/dL | MEAN |
| SECONDARY | Mean Change in Red Blood Cell (RBC) Count and Absolute Reticulocyte Count From Baseline to the End of the Primary Efficacy Period | Baseline; Week 6 | mITT Population. Only participants with available data were analyzed. | 10^6 cells/microliter (µL) | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change in RBC Count and Absolute Reticulocyte Count From Baseline to the End of the Dose Adjustment and Maintenance Period | Baseline; Week 16 | mITT Population. Only participants with available data were analyzed. | 10^6 cells/µL | MEAN |
| SECONDARY | Mean Change in Hematocrit and Reticulocytes From Baseline to the End of the Primary Efficacy Period | Baseline; Week 6 | mITT Population. Only participants with available data were analyzed. | percentage | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change in Hematocrit and Reticulocytes From Baseline to the End of the Dose Adjustment and Maintenance Period | Baseline; Week 16 | mITT Population. Only participants with available data were analyzed. | percentage | MEAN |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group194
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) Levels From Pre-treatment to the End of the Primary Efficacy Period | Vadadustat 150 mg | -0.28 | Standard Error 0.218 | grams per deciliter (g/dL) | |
| Mean Change in Hemoglobin (Hb) Levels From Pre-treatment to the End of the Primary Efficacy Period | Vadadustat 300 mg | 0.08 | Standard Error 0.222 | grams per deciliter (g/dL) | |
| Mean Change in Hemoglobin (Hb) Levels From Pre-treatment to the End of the Primary Efficacy Period | Vadadustat 600 mg | 0.41 | Standard Error 0.233 | grams per deciliter (g/dL) | |
| Mean Change in Hemoglobin (Hb) Levels From Pre-treatment to the End of the Primary Efficacy Period | Placebo | -1.48 | Standard Error 0.226 | grams per deciliter (g/dL) | |
| Time to Reach the Target Hb Level of 10.0 to 12.0 g/dL From Baseline up to Week 16 | Vadadustat 150 mg | 69.3 | Standard Deviation 25.31 | days | |
| Time to Reach the Target Hb Level of 10.0 to 12.0 g/dL From Baseline up to Week 16 | Vadadustat 300 mg | 79.2 | Standard Deviation 24.94 | days | |
| Time to Reach the Target Hb Level of 10.0 to 12.0 g/dL From Baseline up to Week 16 | Vadadustat 600 mg | 54.6 | Standard Deviation 27.90 | days | |
| Time to Reach the Target Hb Level of 10.0 to 12.0 g/dL From Baseline up to Week 16 | Placebo to Vadadustat 300 mg | 57.0 | Standard Deviation 19.80 | days | |
| Time to Reach the Target Hb Level of 10.0 to 12.0 g/dL From Baseline up to Week 16 | Placebo to Vadadustat 600 mg | 85.0 | Standard Deviation NA | days | |
| Mean Hb Levels at the End of the Primary Efficacy Period | Vadadustat 150 mg | 9.064 | Standard Deviation 1.0652 | g/dL |
1 to 10 of 194Source ClinicalTrials.gov
See all 194 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Primary Efficacy Period (6 Weeks) | STARTED | Vadadustat 150 mg | 15 | |
| Primary Efficacy Period (6 Weeks) | STARTED | Vadadustat 300 mg | 15 | |
| Primary Efficacy Period (6 Weeks) | STARTED | Vadadustat 600 mg | 15 | |
| Primary Efficacy Period (6 Weeks) | STARTED | Placebo to Vadadustat 150 mg | 5 | |
| Primary Efficacy Period (6 Weeks) | STARTED | Placebo to Vadadustat 300 mg | 5 | |
| Primary Efficacy Period (6 Weeks) | STARTED | Placebo to Vadadustat 600 mg | 5 | |
| Primary Efficacy Period (6 Weeks) | COMPLETED | Vadadustat 150 mg | 11 | |
| Primary Efficacy Period (6 Weeks) | COMPLETED | Vadadustat 300 mg | 13 | |
| Primary Efficacy Period (6 Weeks) | COMPLETED | Vadadustat 600 mg | 13 | |
| Primary Efficacy Period (6 Weeks) | COMPLETED | Placebo to Vadadustat 150 mg | 3 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events852
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 | Abdominal pain | Gastrointestinal disorders | Primary Efficacy Period: 150 mg Vadadustat | 0 | 15 | |
| other | Abdominal pain | Gastrointestinal disorders | Primary Efficacy Period: 300 mg Vadadustat | 0 | 15 | |
| other | Abdominal pain | Gastrointestinal disorders | Primary Efficacy Period: 600 mg Vadadustat | 1 | 15 | |
| other | Abdominal pain | Gastrointestinal disorders | Primary Efficacy Period: Placebo Matched to 150 mg Vadadustat | 0 | 5 | |
| other | Abdominal pain | Gastrointestinal disorders | Primary Efficacy Period: Placebo Matched to 300 mg Vadadustat | 0 | 5 | |
| other | Abdominal pain | Gastrointestinal disorders | Primary Efficacy Period: Placebo Matched to 600 mg Vadadustat | 0 | 5 | |
| other | Abdominal pain | Gastrointestinal disorders | Dose Adjustment and Maintenance: 150 mg Vadadustat | 1 | 15 | |
| other | Abdominal pain | Gastrointestinal disorders | Dose Adjustment and Maintenance: 300 mg Vadadustat | 0 | 15 | |
| other | Abdominal pain | Gastrointestinal disorders | Dose Adjustment and Maintenance: 600 mg Vadadustat | 0 | 15 | |
| other | Abdominal pain | Gastrointestinal disorders | Dose Adjustment and Maintenance: Placebo to 150 mg Vadadustat | 0 | 5 |
1 to 10 of 852Source ClinicalTrials.gov
See all 852 adverse eventsAdverse event totals36
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Primary Efficacy Period: 150 mg Vadadustat | 8 | 15 |
| Total, all-cause mortality | Primary Efficacy Period: 300 mg Vadadustat | 11 | 15 |
| Total, all-cause mortality | Primary Efficacy Period: 600 mg Vadadustat | 6 | 15 |
| Total, all-cause mortality | Primary Efficacy Period: Placebo Matched to 150 mg Vadadustat | 2 | 5 |
| Total, all-cause mortality | Primary Efficacy Period: Placebo Matched to 300 mg Vadadustat | 2 | 5 |
| Total, all-cause mortality | Primary Efficacy Period: Placebo Matched to 600 mg Vadadustat | 2 | 5 |
| Total, all-cause mortality | Dose Adjustment and Maintenance: 150 mg Vadadustat | 9 | 15 |
| Total, all-cause mortality | Dose Adjustment and Maintenance: 300 mg Vadadustat | 9 | 15 |
| Total, all-cause mortality | Dose Adjustment and Maintenance: 600 mg Vadadustat | 9 | 15 |
| Total, all-cause mortality | Dose Adjustment and Maintenance: Placebo to 150 mg Vadadustat | 1 | 5 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 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.
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/NCT03054350
GET https://conductscience.org/api/trials/v1/NCT03054350/registered?page=2