Trial · NCT01906489
20-Week Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
NCT01906489, 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. 20-Week Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia. Trials, record NCT01906489. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01906489
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 20-Week Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
- NCT number
- NCT01906489
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 210 participants, actual
- Lead sponsor
- Akebia Therapeutics
- Conditions
- Anemia, Chronic Kidney Disease
- Interventions
- AKB-6548, Placebo
- First posted
- 2013-07-24
- Last updated
- 2022-07-21
- Results first posted
- 2022-07-01
Source ClinicalTrials.gov
Registered outcomes47
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving a Successful Hemoglobin Response | Weeks 19 and 20 | Hemoglobin (Hgb) response was defined as participants with mean Hgb ≥11.0 grams per deciliter (g/dL) (average of Weeks 19 and 20) or increase in Hgb by ≥ 1.2 g/dL (average of Weeks 19 and 20) over pre-dose average (average of the two Hgb values obtained prior to dosing) without receiving Erythropoiesis-Stimulating Agents (ESA) or transfusion. |
| Secondary | Percentage of Participants With Hemoglobin Value ≥13.0 g/dL at Any Time During the Study | Up to 20 Weeks | Participants who have experienced an excursion in Hgb to ≥13.0 g/dL at any time during the study were considered as "failures". Data was presented for failures. |
| Secondary | Percentage of Participants Achieving a Successful Hemoglobin Response, Determined Solely Based on the Hemoglobin Value | Weeks 19 and 20 | Hgb response was defined as participants with mean Hgb ≥11.0 g/dL (average of Weeks 19 and 20) or increase in Hgb by ≥ 1.2 g/dL (average of Weeks 19 and 20) over pre-dose average (average of the two Hgb values obtained prior to dosing). Analysis of this secondary outcome measure is a reanalysis of the primary outcome measure whereby the response was determined solely by the Hgb value and receiving rescue therapy did not make the participant a failure. |
| Secondary | Percentage of Participants Achieving a Successful Hemoglobin Response in ESA Treatment naïve Group | Weeks 19 and 20 | Hgb response was defined as participants with mean Hgb ≥11.0 g/dL (average of Weeks 19 and 20) or increase in Hgb by ≥ 1.2 g/dL (average of Weeks 19 and 20) over pre-dose average (average of the two Hgb values obtained prior to dosing) without receiving ESA or transfusion. Participants were assigned to 1 of 3 study groups based on their ESA status at the screening visit: Naïve, Previously Treated and Actively Treated. Analysis of this secondary outcome measure was performed in the ESA Treatment Naïve group, defined as participants who had never received treatment with an ESA and who had a screening Hgb level of ≤10.5 g/dL. |
| Secondary | Percentage of Participants Achieving a Successful Hemoglobin Response in ESA Previously Treated Group | Weeks 19 and 20 | Hgb response was defined as participants with mean Hgb ≥11.0 g/dL (average of Weeks 19 and 20) or increase in Hgb by ≥ 1.2 g/dL (average of Weeks 19 and 20) over pre-dose average (average of the two Hgb values obtained prior to dosing) without receiving ESA or transfusion. Participants were assigned to 1 of 3 study groups based on their ESA status at the screening visit: Naïve, Previously Treated and Actively Treated. Analysis of this secondary outcome measure was performed in the ESA Previously Treated group, defined as participants who had previously received ≥1 dose of an ESA, had been off of ESA therapy for ≥11 weeks at the time of screening, and had a screening Hgb level of ≤10.5 g/dL. |
| Secondary | Percentage of Participants Achieving a Successful Hemoglobin Response in ESA Actively Treated Group | Weeks 19 and 20 | Hgb response was defined as participants with mean Hgb ≥11.0 g/dL (average of Weeks 19 and 20) or increase in Hgb by ≥ 1.2 g/dL (average of Weeks 19 and 20) over pre-dose average (average of the two Hgb values obtained prior to dosing) without receiving ESA or transfusion. Participants were assigned to 1 of 3 study groups based on their ESA status at the screening visit: Naïve, Previously Treated and Actively Treated. Analysis of this secondary outcome measure was performed in the ESA Actively Treated group, defined as participants who had been actively treated with an ESA for a minimum of 4 months before screening, had received at least 2 doses within the last 4 months, had received their last dose within 6 weeks before screening, and had a screening Hgb level ≥9.5 g/dL and ≤12.0 g/dL. |
| Secondary | Percentage of Participants Achieving a Successful Hemoglobin Response, Analyzed in mITT Population | Weeks 19 and 20 | Hgb response was defined as participants with mean Hgb ≥11.0 g/dL (average of Weeks 19 and 20) or increase in Hgb by ≥ 1.2 g/dL (average of Weeks 19 and 20) over pre-dose average (average of the two Hgb values obtained prior to dosing) without receiving ESA or transfusion. Analysis of this secondary outcome measure was performed in the mITT population. |
| Secondary | Change From Baseline in Hemoglobin | Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20 | Blood samples were collected to assess Hgb. Baseline was defined as the mean of two samples obtained prior to dosing (Screening and Baseline). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. A positive change from Baseline indicated Hgb concentration increased. |
| Secondary | Absolute Values of Hemoglobin | Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20 | Blood samples were collected at indicated time points for analysis of hemoglobin |
| Secondary | Change From Baseline in Hematocrit | Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20 | Blood samples were collected to assess Hematocrit. Baseline was defined as the mean of two samples obtained prior to dosing (Screening and Baseline). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. A positive change from Baseline indicated Hematocrit concentration increased. |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 registered outcomesOutcomes47
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving a Successful Hemoglobin Response | Weeks 19 and 20 | Per Protocol (PP) Population: participants in modified intent-to-treat (MITT) Population who had completed the study and had efficacy data through Week 20, had a study medication compliance of ≥ 80%, and did not have any protocol deviations. Only participants with available data were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Hemoglobin Value ≥13.0 g/dL at Any Time During the Study | Up to 20 Weeks | Modified Intent-to-Treat (MITT) Population: all randomized participants who received at least one dose of study medication and had a Baseline (either screening or Baseline for both Hgb and RBC count) and at least one post-Baseline measurement for both Hgb and RBC. Only participants with available data were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Successful Hemoglobin Response, Determined Solely Based on the Hemoglobin Value | Weeks 19 and 20 | MITT Population. Only participants with available data were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Successful Hemoglobin Response in ESA Treatment naïve Group | Weeks 19 and 20 | MITT Population. Only participants with available data were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Successful Hemoglobin Response in ESA Previously Treated Group | Weeks 19 and 20 | MITT Population. Only participants with available data were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Successful Hemoglobin Response in ESA Actively Treated Group | Weeks 19 and 20 | MITT Population. Only participants with available data were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Successful Hemoglobin Response, Analyzed in mITT Population | Weeks 19 and 20 | MITT Population. Only participants with available data were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Hemoglobin | Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20 | MITT Population. Only participants with available data were analyzed. | g/dL | MEAN |
| SECONDARY | Absolute Values of Hemoglobin | Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20 | MITT Population. Only participants with available data were analyzed. | g/dL | MEAN |
| SECONDARY | Change From Baseline in Hematocrit | Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20 | MITT Population. Only participants with available data were analyzed. | Percentage of red blood cells in blood | MEAN |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 outcomesResults by group186
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving a Successful Hemoglobin Response | Vadadustat | 54.9 | Percentage of participants | ||
| Percentage of Participants Achieving a Successful Hemoglobin Response | Placebo | 10.3 | Percentage of participants | ||
| Percentage of Participants With Hemoglobin Value ≥13.0 g/dL at Any Time During the Study | Vadadustat | 59.6 | Percentage of participants | ||
| Percentage of Participants With Hemoglobin Value ≥13.0 g/dL at Any Time During the Study | Placebo | 88.9 | Percentage of participants | ||
| Percentage of Participants Achieving a Successful Hemoglobin Response, Determined Solely Based on the Hemoglobin Value | Vadadustat | 44.9 | Percentage of participants | ||
| Percentage of Participants Achieving a Successful Hemoglobin Response, Determined Solely Based on the Hemoglobin Value | Placebo | 13.9 | Percentage of participants | ||
| Percentage of Participants Achieving a Successful Hemoglobin Response in ESA Treatment naïve Group | Vadadustat | 50 | Percentage of participants | ||
| Percentage of Participants Achieving a Successful Hemoglobin Response in ESA Treatment naïve Group | Placebo | 7.9 | Percentage of participants | ||
| Percentage of Participants Achieving a Successful Hemoglobin Response in ESA Previously Treated Group | Vadadustat | 41.5 | Percentage of participants | ||
| Percentage of Participants Achieving a Successful Hemoglobin Response in ESA Previously Treated Group | Placebo | 19 | Percentage of participants |
1 to 10 of 186Source ClinicalTrials.gov
See all 186 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vadadustat | 138 | |
| Overall Study | STARTED | Placebo | 72 | |
| Overall Study | COMPLETED | Vadadustat | 112 | |
| Overall Study | COMPLETED | Placebo | 63 | |
| Overall Study | NOT COMPLETED | Vadadustat | 26 | |
| Overall Study | NOT COMPLETED | Placebo | 9 |
Source ClinicalTrials.gov
Adverse events106
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 | Diarrhoea | Gastrointestinal disorders | Vadadustat | 14 | 138 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 3 | 72 | |
| other | Nausea | Gastrointestinal disorders | Vadadustat | 14 | 138 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 3 | 72 | |
| other | Constipation | Gastrointestinal disorders | Vadadustat | 5 | 138 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 4 | 72 | |
| other | Fatigue | General disorders | Vadadustat | 11 | 138 | |
| other | Fatigue | General disorders | Placebo | 5 | 72 | |
| other | Oedema peripheral | General disorders | Vadadustat | 10 | 138 | |
| other | Oedema peripheral | General disorders | Placebo | 7 | 72 |
1 to 10 of 106Source ClinicalTrials.gov
See all 106 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vadadustat | 3 | 138 |
| Total, all-cause mortality | Placebo | 0 | 72 |
| Total, other adverse events | Vadadustat | 58 | 138 |
| Total, other adverse events | Placebo | 29 | 72 |
| Total, serious adverse events | Vadadustat | 33 | 138 |
| Total, serious adverse events | Placebo | 11 | 72 |
Source ClinicalTrials.gov
Papers2
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Vadadustat vs Placebo: Number of Participants With Clinically Abnormal 12-Lead Electrocardiogram (ECG) Findings | Trial comparisons |
| Vadadustat vs Placebo: Number of Participants With Clinically Significant Changes From Baseline in Vital Signs | Trial comparisons |
| Vadadustat vs Placebo: Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Findings | Trial comparisons |
| Vadadustat vs Placebo: deaths from any cause | Trial comparisons |
| Vadadustat vs Placebo: serious adverse events | Trial comparisons |
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/NCT01906489
GET https://conductscience.org/api/trials/v1/NCT01906489/registered?page=2