AnemiaPhase 2NCT01235936
Safety and Efficacy Study for AKB-6548 in Participants With Chronic Kidney Disease and Anemia
A Phase 2 study testing AKB-6548 in people with Anemia and Kidney Disease, run by Akebia Therapeutics at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety, pharmacodynamics and pharmacokinetics of repeat doses of orally administered AKB-6548 in pre-dialysis participants with anemia. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Anemia, Kidney Disease
- What is being tested?
- AKB-6548
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Oct 2010to May 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 79 years of age, inclusive
- Chronic Kidney Disease Stage 3 or Stage 4
- Hemoglobin (Hgb) < 10.5 g/dl
- TSAT > 20% and CBC indicating normocytic red blood cell morphology
Who cannot join
- BMI > 40
- Red blood cell transfusion within 12 weeks.
- Androgen therapy within the previous 21 days prior to study dosing
- Therapy with any approved or experimental erythropoiesis stimulating agent (ESA) within the 10 weeks prior to the Screening visit
- Participants meeting the criteria of ESA resistance within the previous 4 months
- Individual doses of intravenous iron of 250 mg or larger within the past 21 days
Show all 12Show fewer
- AST or ALT >1.8x ULN.
- Alkaline phosphatase >2x ULN.
- Total bilirubin >1.5x ULN.
- Uncontrolled hypertension
- New York Heart Association Class III or IV congestive heart failure
- Myocardial infarction, acute coronary syndrome, or stroke within 6 months prior to dosing
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Augusta, Georgia
Study site
San Antonio, Texas
About this study
Official title: Phase 2a Open-Label Pilot Study to Assess the Pharmacodynamic Response, Pharmacokinetics, Safety, and Tolerability of 28-Day Repeat Oral Doses of AKB-6548 in Subjects With Anemia Secondary to Chronic Kidney Disease (CKD), Stages 3 and/or 4
The purpose of this study is to evaluate the safety, pharmacodynamics and pharmacokinetics of repeat doses of orally administered AKB-6548 in pre-dialysis participants with anemia.
- Conditions
- Anemia, Kidney Disease
- Being tested
- AKB-6548
- Keywords
- anemia, chronic kidney disease, CKD, chronic renal insufficiency, renal impairment, erythropoietin, safety, efficacy, tolerability, pharmacokinetics
- Medical subject headings
- Anemia, Kidney Diseases, Renal Insufficiency, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AKB-6548Drug
Different dose levels
| Study group | Role | What they receive |
|---|---|---|
| AKB-6548 | Experimental | Not described Receives: Drug: AKB-6548 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Hemoglobin (Hgb) on 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.
Measured: Baseline; Day 29
Secondary outcomes (19)
Mean Change From Baseline in Hematocrit on Day 29
Blood samples were collected to assess hematocrit. A positive change from baseline indicates hematocrit concentration increased.
Measured: Baseline; Day 29
Mean Change From Baseline in Total Red Blood Cell (RBC) Count on 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.
Measured: Baseline; Day 29
Mean Change From Baseline in Absolute Reticulocyte Count on 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.
Measured: Baseline; Day 29
Mean Change From Baseline in Reticulocyte Hemoglobin (Hgb) Content on 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.
Measured: Baseline; Day 29
Number of Participants With Absolute Change From Baseline in Hemoglobin (Hgb) at 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).
Measured: Day 29
Number of Participants With the Percentage Change From Baseline in Hemoglobin (Hgb) at 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).
Measured: Day 29
Number of Participants With Percentage Change From Baseline in Hematocrit at Day 29
Blood samples were collected to assess hematocrit.
Measured: Day 29
Number of Participants With Percentage Change From Baseline in Red Blood Cell (RBC) Count at 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).
Measured: Day 29
Number of Participants With Change From Baseline in Absolute Reticulocyte Count at 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).
Measured: Day 29
Change From Baseline in Ferritin on Day 29
Blood samples were collected to assess ferritin. A positive change from baseline indicates ferritin content increased.
Measured: Baseline; Day 29
Change From Baseline in Iron on Day 29
Blood samples were collected to assess iron. A positive change from baseline indicates iron content increased.
Measured: Baseline; Day 29
Change From Baseline in Total Iron Binding Capacity on Day 29
Blood samples were collected to assess total iron binding capacity. A positive change from baseline indicates total iron binding capacity increased.
Measured: Baseline; Day 29
Change From Baseline in Transferrin Saturation on Day 29
Blood samples were collected to assess transferrin saturation. The transferrin saturation is the ratio of the serum iron concentration and the total iron-binding capacity, expressed as a percentage. A positive change from baseline indicates transferrin saturation increased.
Measured: Baseline; Day 29
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An Adverse Event (AE) was defined as any untoward medical occurrence, signs, symptoms, disease, or laboratory or physiological observations occurring in a participant administered with drug, regardless of a causal relationship with that treatment or usage. This also included all suspected adverse medication reactions, reactions from medication overdose, abuse, withdrawal, sensitivity, toxicity, unrelated illnesses, including worsening a pre-existing condition, injury, or accidents. Serious Adverse Events (SAEs) was defined as any life-threatening condition; hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or death.
Measured: Up to 2 weeks post 28 days of treatment
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values
Parameters assessed for laboratory values included hematology, chemistry, urinalysis, and coagulation. The investigator was responsible for reviewing laboratory results for clinically significant changes.
Measured: Up to 2 weeks post 28 days of treatment
Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values
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 laboratory results for clinically significant changes.
Measured: Up to 2 weeks post 28 days of treatment
Number of Participants With Clinically Abnormal 12-Lead Electrocardiogram (ECG) Findings
A standard 12-lead ECG was performed following dosing in a supine position for approximately 10 minutes. ECGs were taken prior to blood draws when possible. The investigator was responsible for reviewing laboratory results for clinical significance.
Measured: Up to 2 weeks post 28 days of treatment
Mean Change From Baseline in PR Interval, QT Interval, QRS Interval, and QT Corrected (QTc) Interval
A standard 12-lead ECG was performed following dosing in a supine position for approximately 10 minutes. ECGs were taken prior to blood draws when possible. The parameters evaluated from the participant ECG trace included PR interval, QT interval, QRS interval, and QTc (corrected).
Measured: Up to 2 weeks post 28 days of treatment
Mean Trough Concentrations of Vadadustat at Day 8, 15, 22 and 29
Serum samples were collected from the participants at the defined time points. Trough concentration was defined as the concentration of drug in the blood immediately before the next dose is administered. Trough concentration was calculated using the validated liquid chromatography-mass spectrometry (LC-MS) and liquid chromatography-tandem mass spectrometry (LC-MS/MS) method
Measured: Pre-dose at Day 8, 15, 22 and 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2010 (estimated)
- Study start21 Oct 2010
- Primary completion13 Apr 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akebia Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, Akebia Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01235936
- Sponsor's protocol ID
- AKB-6548-CI-0004
- Status last verified
- Jun 2022
- First submitted
- 5 Nov 2010
- Last updated
- 1 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2a Open-Label Pilot Study to Assess the Pharmacodynamic Response, Pharmacokinetics, Safety, and Tolerability of 28-Day Repeat Oral Doses of AKB-6548 in Subjects With Anemia Secondary to Chronic Kidney Disease (CKD), Stages 3 and/or 4
- ClinicalTrials.gov ID
- NCT01235936
- Acronym / sponsor ID
- AKB-6548-CI-0004
- Conditions
- Anemia, Kidney Disease
- Keywords
- anemia, chronic kidney disease, CKD, chronic renal insufficiency, renal impairment, erythropoietin, safety, efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Akebia TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2010
- Primary completion
- 13 Apr 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 8 Nov 2010 (estimated)
- Results
- Posted 1 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, pharmacodynamics and pharmacokinetics of repeat doses of orally administered AKB-6548 in pre-dialysis participants with anemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AKB-6548 | Experimental | Drug: AKB-6548 |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 to 79 years of age, inclusive
- Chronic Kidney Disease Stage 3 or Stage 4
- Hemoglobin (Hgb) < 10.5 g/dl
- TSAT > 20% and CBC indicating normocytic red blood cell morphology
Key exclusion criteria (12 listed)
- BMI > 40
- Red blood cell transfusion within 12 weeks.
- Androgen therapy within the previous 21 days prior to study dosing
- Therapy with any approved or experimental erythropoiesis stimulating agent (ESA) within the 10 weeks prior to the Screening visit
- Participants meeting the criteria of ESA resistance within the previous 4 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AKB-6548Different dose levels | Drug | AKB-6548 |
Primary outcome
Mean Change From Baseline in Hemoglobin (Hgb) on Day 29
Time frame: 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.
19 secondary outcomes
Mean Change From Baseline in Hematocrit on Day 29
Time frame: Baseline; Day 29
Mean Change From Baseline in Total Red Blood Cell (RBC) Count on Day 29
Time frame: Baseline; Day 29
Mean Change From Baseline in Absolute Reticulocyte Count on Day 29
Time frame: Baseline; Day 29
Mean Change From Baseline in Reticulocyte Hemoglobin (Hgb) Content on Day 29
Time frame: Baseline; Day 29
Number of Participants With Absolute Change From Baseline in Hemoglobin (Hgb) at Day 29
Time frame: Day 29
Number of Participants With the Percentage Change From Baseline in Hemoglobin (Hgb) at Day 29
Time frame: Day 29
Number of Participants With Percentage Change From Baseline in Hematocrit at Day 29
Time frame: Day 29
Number of Participants With Percentage Change From Baseline in Red Blood Cell (RBC) Count at Day 29
Time frame: Day 29
Number of Participants With Change From Baseline in Absolute Reticulocyte Count at Day 29
Time frame: Day 29
Change From Baseline in Ferritin on Day 29
Time frame: Baseline; Day 29
Change From Baseline in Iron on Day 29
Time frame: Baseline; Day 29
Change From Baseline in Total Iron Binding Capacity on Day 29
Time frame: Baseline; Day 29
Change From Baseline in Transferrin Saturation on Day 29
Time frame: Baseline; Day 29
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 2 weeks post 28 days of treatment
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values
Time frame: Up to 2 weeks post 28 days of treatment
Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values
Time frame: Up to 2 weeks post 28 days of treatment
Number of Participants With Clinically Abnormal 12-Lead Electrocardiogram (ECG) Findings
Time frame: Up to 2 weeks post 28 days of treatment
Mean Change From Baseline in PR Interval, QT Interval, QRS Interval, and QT Corrected (QTc) Interval
Time frame: Up to 2 weeks post 28 days of treatment
Mean Trough Concentrations of Vadadustat at Day 8, 15, 22 and 29
Time frame: Pre-dose at Day 8, 15, 22 and 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chief Medical Officer study director
Akebia Therapeutics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AKB-6548 in people with Anemia and Kidney Disease, run by Akebia Therapeutics at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in Hemoglobin (Hgb) on Day 29 (time frame: Baseline; Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2022.