Trial · NCT01235936
Safety and Efficacy Study for AKB-6548 in Participants With Chronic Kidney Disease and Anemia
NCT01235936, Phase 2, Completed, Akebia Therapeutics; results first posted 2022-07-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study for AKB-6548 in Participants With Chronic Kidney Disease and Anemia. Trials, record NCT01235936. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01235936
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study for AKB-6548 in Participants With Chronic Kidney Disease and Anemia
- NCT number
- NCT01235936
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Akebia Therapeutics
- Conditions
- Anemia, Kidney Disease
- Interventions
- AKB-6548
- First posted
- 2010-11-08
- Last updated
- 2022-07-01
- Results first posted
- 2022-07-01
- Limitations and caveats
This pilot study planned to include 15 participants with either Stage 3 or 4 CKD, with no minimum or maximum enrollment target for either stage; however, because of slow enrollment the Sponsor terminated the study early after only 10 participants had enrolled. The overall status of the study was considered as completed since 10 participants received Vadadustat and all 10 participants completed the study per protocol.
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Hemoglobin (Hgb) on Day 29 | Baseline; Day 29 | Blood samples were collected to assess Hgb. Baseline Hgb was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). A positive change from baseline indicates that hemoglobin concentration increased. |
| Secondary | Mean Change From Baseline in Hematocrit on Day 29 | Baseline; Day 29 | Blood samples were collected to assess hematocrit. A positive change from baseline indicates hematocrit concentration increased. |
| Secondary | Mean Change From Baseline in Total Red Blood Cell (RBC) Count on Day 29 | Baseline; Day 29 | Blood samples were collected to assess RBC count. Baseline RBC count was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). A positive change from baseline indicates RBC count increased. |
| Secondary | Mean Change From Baseline in Absolute Reticulocyte Count on Day 29 | Baseline; Day 29 | Blood samples were collected to assess reticulocyte count. Baseline absolute reticulocyte count was defined as the average of the 3 reticulocyte counts obtained prior to dosing (Screening, Pre- Baseline, and Baseline). A positive change from baseline indicates absolute reticulocyte count increased. |
| Secondary | Mean Change From Baseline in Reticulocyte Hemoglobin (Hgb) Content on Day 29 | Baseline; Day 29 | Blood samples were collected to assess reticulocyte Hgb. Baseline Hgb was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). A positive change from baseline indicates reticulocyte Hgb content increased. |
| Secondary | Number of Participants With Absolute Change From Baseline in Hemoglobin (Hgb) at Day 29 | Day 29 | Blood samples were collected to assess Hgb. Baseline Hgb was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). |
| Secondary | Number of Participants With the Percentage Change From Baseline in Hemoglobin (Hgb) at Day 29 | Day 29 | Blood samples were collected to assess Hgb. Baseline Hgb was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). |
| Secondary | Number of Participants With Percentage Change From Baseline in Hematocrit at Day 29 | Day 29 | Blood samples were collected to assess hematocrit. |
| Secondary | Number of Participants With Percentage Change From Baseline in Red Blood Cell (RBC) Count at Day 29 | Day 29 | Blood samples were collected to assess RBC count. Baseline RBC count was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). |
| Secondary | Number of Participants With Change From Baseline in Absolute Reticulocyte Count at Day 29 | Day 29 | Blood samples were collected to assess reticulocyte count. Baseline absolute reticulocyte count was defined as the average of the 3 reticulocyte counts obtained prior to dosing (Screening, Pre- Baseline, and Baseline). |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in Hemoglobin (Hgb) on Day 29 | Baseline; Day 29 | Full Analysis Set: All participants who received at least 1 dose of study medication. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Grams per decilitre (g/dL) | MEAN |
| SECONDARY | Mean Change From Baseline in Hematocrit on Day 29 | Baseline; Day 29 | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Percentage of red blood cells in blood | MEAN |
| SECONDARY | Mean Change From Baseline in Total Red Blood Cell (RBC) Count on Day 29 | Baseline; Day 29 | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Million cells per cubic millimeter | MEAN |
| SECONDARY | Mean Change From Baseline in Absolute Reticulocyte Count on Day 29 | Baseline; Day 29 | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Cells per Microlitre | MEAN |
| SECONDARY | Mean Change From Baseline in Reticulocyte Hemoglobin (Hgb) Content on Day 29 | Baseline; Day 29 | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Picograms | MEAN |
| SECONDARY | Number of Participants With Absolute Change From Baseline in Hemoglobin (Hgb) at Day 29 | Day 29 | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With the Percentage Change From Baseline in Hemoglobin (Hgb) at Day 29 | Day 29 | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Percentage Change From Baseline in Hematocrit at Day 29 | Day 29 | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Percentage Change From Baseline in Red Blood Cell (RBC) Count at Day 29 | Day 29 | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Change From Baseline in Absolute Reticulocyte Count at Day 29 | Day 29 | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in Hemoglobin (Hgb) on Day 29 | Vadadustat | Baseline | 9.91 | Standard Deviation 0.63 | Grams per decilitre (g/dL) |
| Mean Change From Baseline in Hemoglobin (Hgb) on Day 29 | Vadadustat | Change from Baseline on Day 29 | 0.63 | Standard Deviation 0.46 | Grams per decilitre (g/dL) |
| Mean Change From Baseline in Hematocrit on Day 29 | Vadadustat | Baseline | 30.43 | Standard Deviation 2.69 | Percentage of red blood cells in blood |
| Mean Change From Baseline in Hematocrit on Day 29 | Vadadustat | Change from Baseline on Day 29 | 1.62 | Standard Deviation 1.71 | Percentage of red blood cells in blood |
| Mean Change From Baseline in Total Red Blood Cell (RBC) Count on Day 29 | Vadadustat | Baseline | 3.313 | Standard Deviation 0.389 | Million cells per cubic millimeter |
| Mean Change From Baseline in Total Red Blood Cell (RBC) Count on Day 29 | Vadadustat | Change from Baseline on Day 29 | 0.167 | Standard Deviation 0.170 | Million cells per cubic millimeter |
| Mean Change From Baseline in Absolute Reticulocyte Count on Day 29 | Vadadustat | Baseline | 51076.00 | Standard Deviation 24975.76 | Cells per Microlitre |
| Mean Change From Baseline in Absolute Reticulocyte Count on Day 29 | Vadadustat | Change from Baseline on Day 29 | 18647.00 | Standard Deviation 18289.84 | Cells per Microlitre |
| Mean Change From Baseline in Reticulocyte Hemoglobin (Hgb) Content on Day 29 | Vadadustat | Baseline | 31.49 | Standard Deviation 2.44 | Picograms |
| Mean Change From Baseline in Reticulocyte Hemoglobin (Hgb) Content on Day 29 | Vadadustat | Change from Baseline on Day 29 | 0.13 | Standard Deviation 0.84 | Picograms |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vadadustat | 10 | |
| Overall Study | COMPLETED | Vadadustat | 10 | |
| Overall Study | NOT COMPLETED | Vadadustat | 0 |
Source ClinicalTrials.gov
Adverse events13
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 | Constipation | Gastrointestinal disorders | Vadadustat | 1 | 10 | |
| other | Diarrhoea | Gastrointestinal disorders | Vadadustat | 2 | 10 | |
| other | Dyspepsia | Gastrointestinal disorders | Vadadustat | 1 | 10 | |
| other | Nausea | Gastrointestinal disorders | Vadadustat | 1 | 10 | |
| other | Chills | General disorders | Vadadustat | 1 | 10 | |
| other | Fatigue | General disorders | Vadadustat | 1 | 10 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Vadadustat | 1 | 10 | |
| other | Hyperkalaemia | Metabolism and nutrition disorders | Vadadustat | 1 | 10 | |
| other | Muscle spasms | Musculoskeletal and connective tissue disorders | Vadadustat | 1 | 10 | |
| other | Dizziness | Nervous system disorders | Vadadustat | 1 | 10 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vadadustat | 0 | 10 |
| Total, other adverse events | Vadadustat | 5 | 10 |
| Total, serious adverse events | Vadadustat | 0 | 10 |
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/NCT01235936
GET https://conductscience.org/api/trials/v1/NCT01235936/results?page=2