Trial · NCT01381094
42-Day Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
NCT01381094, 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. 42-Day Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia. Trials, record NCT01381094. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01381094
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 42-Day Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
- NCT number
- NCT01381094
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 93 participants, actual
- Lead sponsor
- Akebia Therapeutics
- Conditions
- Anemia, Kidney Disease
- Interventions
- AKB-6548, Placebo
- First posted
- 2011-06-27
- Last updated
- 2022-07-01
- Results first posted
- 2022-07-01
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute Change From Baseline in Hemoglobin (Hgb) to End of Treatment (Week 6) | Baseline, Week 6 | Absolute change from Baseline was calculated as the Week 6 (end of treatment) value minus the Baseline value. Baseline Hgb was defined as the average of the last two measurements obtained prior to dosing. If there was only one measurement prior to dosing, this measurement served as Baseline. A positive change from Baseline indicated that hemoglobin concentration increased. |
| Secondary | Change From Baseline in Hgb at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) | Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8) | Change from Baseline was calculated as the visit value minus the Baseline value. Baseline Hgb was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated that hemoglobin concentration increased. |
| Secondary | Change From Baseline in Hematocrit (HCT) at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) | Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8) | Change from Baseline was calculated as the visit value minus the Baseline value. Baseline HCT was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated HCT concentration increased. |
| Secondary | Change From Baseline in Red Blood Cell (RBC) Count at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) | Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8) | Change from Baseline was calculated as the visit value minus the Baseline value. Baseline RBC count was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated RBC count increased. |
| Secondary | Change From Baseline in Absolute Reticulocyte Count at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) | Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8) | Change from Baseline was calculated as the visit value minus the Baseline value. Baseline Reticulocyte count was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated reticulocyte count increased. |
| Secondary | Change From Baseline in Reticulocyte Hgb Content at Week 6 | Baseline, Week 6 | Change from Baseline was calculated as the Week 6 value minus the Baseline value. Baseline Reticulocyte count was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated reticulocyte Hgb content increased. |
| Secondary | Maximum Change From Baseline in Hgb | Baseline; up to Week 8 | Change from Baseline was calculated as the maximum value minus the Baseline value. Baseline Hgb was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated that hemoglobin concentration increased. |
| Secondary | Maximum Change From Baseline in HCT | Baseline; up to Week 8 | Change from Baseline was calculated as the maximum value minus the Baseline value. Baseline HCT was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated that HCT concentration increased. |
| Secondary | Maximum Change From Baseline in RBC Count | Baseline; up to Week 8 | Change from Baseline was calculated as the maximum value minus the Baseline value. Baseline RBC Count was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated that RBC count increased. |
| Secondary | Maximum Change in Absolute Reticulocyte Count From Baseline | Baseline; up to Week 8 | Change from Baseline was calculated as the maximum value minus the Baseline value. Baseline absolute reticulocyte count was defined as the average of the last two measurements obtained prior to dosing; if there was only one value prior to dosing, this value served as Baseline. A positive change from Baseline indicated that reticulocyte count increased. |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Absolute Change From Baseline in Hemoglobin (Hgb) to End of Treatment (Week 6) | Baseline, Week 6 | Modified intent-to-treat (MITT) population: All randomized participants who received at least one dose of study medication and had a Baseline (both Screening and Baseline for Hgb and red blood cells \[RBC\] count) and at least one post-baseline measurement. Participants with available data were included in the analysis. | Grams per deciliter (g/dL) | MEAN |
| SECONDARY | Change From Baseline in Hgb at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) | Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8) | MITT population. Participants with available data were included in the analysis. | g/dL | MEAN |
| SECONDARY | Change From Baseline in Hematocrit (HCT) at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) | Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8) | MITT population. Participants with available data were included in the analysis. | Percentage of red blood cells in blood | MEAN |
| SECONDARY | Change From Baseline in Red Blood Cell (RBC) Count at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) | Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8) | MITT population. Participants with available data were included in the analysis. | 10^6 cells/microliter (10^6 cells/μL) | MEAN |
| SECONDARY | Change From Baseline in Absolute Reticulocyte Count at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8) | Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8) | MITT population. Participants with available data were included in the analysis. | 10^6 cells/μL | MEAN |
| SECONDARY | Change From Baseline in Reticulocyte Hgb Content at Week 6 | Baseline, Week 6 | MITT population. Participants with available data were included in the analysis. | Picogram | MEAN |
| SECONDARY | Maximum Change From Baseline in Hgb | Baseline; up to Week 8 | MITT population. Participants with available data were included in the analysis. | g/dL | MEAN |
| SECONDARY | Maximum Change From Baseline in HCT | Baseline; up to Week 8 | MITT population. Participants with available data were included in the analysis. | Percentage of red blood cells | MEAN |
| SECONDARY | Maximum Change From Baseline in RBC Count | Baseline; up to Week 8 | MITT population. Participants with available data were included in the analysis. | 10^6 cells/μL | MEAN |
| SECONDARY | Maximum Change in Absolute Reticulocyte Count From Baseline | Baseline; up to Week 8 | MITT population. Participants with available data were included in the analysis. | 10^6 cells/μL | MEAN |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group500
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Absolute Change From Baseline in Hemoglobin (Hgb) to End of Treatment (Week 6) | AKB-6548 240 mg | Baseline | 9.46 | Standard Deviation 0.792 | Grams per deciliter (g/dL) |
| Absolute Change From Baseline in Hemoglobin (Hgb) to End of Treatment (Week 6) | AKB-6548 370 mg | Baseline | 9.93 | Standard Deviation 0.643 | Grams per deciliter (g/dL) |
| Absolute Change From Baseline in Hemoglobin (Hgb) to End of Treatment (Week 6) | AKB-6548 500 mg | Baseline | 9.86 | Standard Deviation 0.606 | Grams per deciliter (g/dL) |
| Absolute Change From Baseline in Hemoglobin (Hgb) to End of Treatment (Week 6) | AKB-6548 630 mg | Baseline | 9.67 | Standard Deviation 0.796 | Grams per deciliter (g/dL) |
| Absolute Change From Baseline in Hemoglobin (Hgb) to End of Treatment (Week 6) | Placebo | Baseline | 9.83 | Standard Deviation 0.677 | Grams per deciliter (g/dL) |
| Absolute Change From Baseline in Hemoglobin (Hgb) to End of Treatment (Week 6) | AKB-6548 240 mg | Change from Baseline at Week 6 | 0.77 | Standard Deviation 0.665 | Grams per deciliter (g/dL) |
| Absolute Change From Baseline in Hemoglobin (Hgb) to End of Treatment (Week 6) | AKB-6548 370 mg | Change from Baseline at Week 6 | 0.73 | Standard Deviation 0.623 | Grams per deciliter (g/dL) |
| Absolute Change From Baseline in Hemoglobin (Hgb) to End of Treatment (Week 6) | AKB-6548 500 mg | Change from Baseline at Week 6 | 1.25 | Standard Deviation 0.644 | Grams per deciliter (g/dL) |
| Absolute Change From Baseline in Hemoglobin (Hgb) to End of Treatment (Week 6) | AKB-6548 630 mg | Change from Baseline at Week 6 | 1.43 | Standard Deviation 0.668 | Grams per deciliter (g/dL) |
| Absolute Change From Baseline in Hemoglobin (Hgb) to End of Treatment (Week 6) | Placebo | Change from Baseline at Week 6 | -0.03 | Standard Deviation 0.649 | Grams per deciliter (g/dL) |
1 to 10 of 500Source ClinicalTrials.gov
See all 500 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AKB-6548 240 mg | 18 | |
| Overall Study | STARTED | AKB-6548 370 mg | 18 | |
| Overall Study | STARTED | AKB-6548 500 mg | 17 | |
| Overall Study | STARTED | AKB-6548 630 mg | 19 | |
| Overall Study | STARTED | Placebo | 19 | |
| Overall Study | COMPLETED | AKB-6548 240 mg | 16 | |
| Overall Study | COMPLETED | AKB-6548 370 mg | 15 | |
| Overall Study | COMPLETED | AKB-6548 500 mg | 17 | |
| Overall Study | COMPLETED | AKB-6548 630 mg | 18 | |
| Overall Study | COMPLETED | Placebo | 18 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events330
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 | AKB-6548 240 mg | 0 | 18 | |
| other | Anaemia | Blood and lymphatic system disorders | AKB-6548 370 mg | 0 | 18 | |
| other | Anaemia | Blood and lymphatic system disorders | AKB-6548 500 mg | 0 | 17 | |
| other | Anaemia | Blood and lymphatic system disorders | AKB-6548 630 mg | 0 | 19 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 2 | 19 | |
| other | Neutropenia | Blood and lymphatic system disorders | AKB-6548 240 mg | 0 | 18 | |
| other | Neutropenia | Blood and lymphatic system disorders | AKB-6548 370 mg | 0 | 18 | |
| other | Neutropenia | Blood and lymphatic system disorders | AKB-6548 500 mg | 0 | 17 | |
| other | Neutropenia | Blood and lymphatic system disorders | AKB-6548 630 mg | 1 | 19 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo | 0 | 19 |
1 to 10 of 330Source ClinicalTrials.gov
See all 330 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AKB-6548 240 mg | 0 | 18 |
| Total, all-cause mortality | AKB-6548 370 mg | 1 | 18 |
| Total, all-cause mortality | AKB-6548 500 mg | 0 | 17 |
| Total, all-cause mortality | AKB-6548 630 mg | 0 | 19 |
| Total, all-cause mortality | Placebo | 0 | 19 |
| Total, other adverse events | AKB-6548 240 mg | 9 | 18 |
| Total, other adverse events | AKB-6548 370 mg | 5 | 18 |
| Total, other adverse events | AKB-6548 500 mg | 8 | 17 |
| Total, other adverse events | AKB-6548 630 mg | 11 | 19 |
| Total, other adverse events | Placebo | 11 | 19 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
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.
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