AnemiaPhase 2NCT01381094
42-Day Repeat Oral Dose Study of 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 28 sites in United States.
Trial summary
The purpose of this study is to evaluate the dose response (efficacy), pharmacodynamic response, pharmacokinetics, safety, and tolerability of orally administered AKB-6548 in pre-dialysis participants with anemia with repeat dosing for 42 days. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 28 sitesUnited States
- Study dates
- 15 Jun 2011to 16 Feb 2012
- 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 (eGFR <60 mL/min), not yet on dialysis
- Hemoglobin (Hgb) ≤ 10.5 g/dL
- Transferring saturation ≥ 20%
- Ferritin ≥ 50 ng/mL
Who cannot join
- Body mass index >42
- 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 11 weeks prior to the Screening visit
- Participants meeting the criteria of ESA resistance within the previous 4 months
- Individual doses of intravenous iron of greater than 250 mg within the past 21 days
Show all 12Show fewer
- Aspartate aminotransferase or alanine aminotransferase >1.8x upper limit of normal (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
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Study site
Augusta, Georgia
Study site
Austin, Texas
Study site
Bethpage, New York
Study site
Coral Springs, Florida
Study site
Covina, California
Study site
Detroit, Michigan
Study site
Fort Worth, Texas
Study site
Houston, Texas
Study site
Knoxville, Tennessee
Study site
Lauderdale Lakes, Florida
Study site
Los Angeles, California
Study site
Lynwood, California
Study site
Macon, Georgia
Study site
Miami, Florida
Study site
Mineola, New York
Study site
Ocala, Florida
Study site
Oklahoma City, Oklahoma
Study site
Pine Bluff, Arkansas
Study site
Pontiac, Michigan
Study site
Riverside, California
Study site
San Antonio, Texas
Study site
San Dimas, California
Study site
Shreveport, Louisiana
Study site
Springfield, Massachusetts
Study site
Warren, Michigan
Study site
Whittier, California
Study site
Wichita, Kansas
Study site
Wilmington, North Carolina
About this study
Official title: Phase 2a Randomized, Double-Blind, Placebo-Controlled, Dose Range Study to Assess the Pharmacodynamic Response, Pharmacokinetics, Safety, and Tolerability of 42-Day Repeat Oral Doses of AKB-6548 in Subjects With Anemia Secondary to Chronic Kidney Disease (CKD), Stages 3 and 4
The purpose of this study is to evaluate the dose response (efficacy), pharmacodynamic response, pharmacokinetics, safety, and tolerability of orally administered AKB-6548 in pre-dialysis participants with anemia with repeat dosing for 42 days.
- Conditions
- Anemia, Kidney Disease
- Being tested
- AKB-6548, Placebo
- 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
oral dose administered once daily for 42 days
PlaceboDrug
oral Placebo administered once daily for 42 days
| Study group | Role | What they receive |
|---|---|---|
| AKB-6548 240 mg | Experimental | Not described Receives: Drug: AKB-6548 |
| AKB-6548 370 mg | Experimental | Not described Receives: Drug: AKB-6548 |
| AKB-6548 500 mg | Experimental | Not described Receives: Drug: AKB-6548 |
| AKB-6548 630 mg | Experimental | Not described Receives: Drug: AKB-6548 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change From Baseline in Hemoglobin (Hgb) to End of Treatment (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.
Measured: Baseline, Week 6
Secondary outcomes (28)
Change From Baseline in Hgb at Week 1, Week 2, Week 4, Week 6, and 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.
Measured: Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)
Change From Baseline in Hematocrit (HCT) at Week 1, Week 2, Week 4, Week 6, and 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.
Measured: Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)
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)
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.
Measured: Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)
Change From Baseline in Absolute Reticulocyte Count at Week 1, Week 2, Week 4, Week 6, and 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.
Measured: Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)
Change From Baseline in Reticulocyte Hgb Content at 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.
Measured: Baseline, Week 6
Maximum Change From Baseline in Hgb
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.
Measured: Baseline; up to Week 8
Maximum Change From Baseline in HCT
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.
Measured: Baseline; up to Week 8
Maximum Change From Baseline in RBC Count
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.
Measured: Baseline; up to Week 8
Maximum Change in Absolute Reticulocyte Count From Baseline
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.
Measured: Baseline; up to Week 8
Number of Participants With Absolute Change From Baseline in Hgb ≥ 0.4, 0.6, 0.8, and 1.0 g/dL at the End of Dosing Period
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.
Measured: Up to Week 6 (End of the Dosing Period)
Number of Participants With Change From Baseline in Hgb ≥5.0, 7.5, and 10.0% by the End of Dosing Period
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.
Measured: Up to Week 6 (End of The Dosing Period)
Number of Participants With Change From Baseline in HCT ≥5.0, 7.5, and 10.0% by the End of Dosing Period
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.
Measured: Up to Week 6 (End of The Dosing Period)
Number of Participants With Change From Baseline in RBC Count ≥5.0, 7.5, and 10.0% by the End of Dosing Period
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.
Measured: Up to Week 6 (End of The Dosing Period)
Number of Participants With Change From Baseline in Reticulocyte Count ≥6000, 12000, and 18000 Cells/uL by the End of Dosing Period
Change from Baseline was calculated as the maximum value minus the Baseline value. Baseline reticulocytes 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.
Measured: Up to Week 6 (End of The Dosing Period)
Change From Baseline in Total Iron at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)
Change from Baseline was calculated as the visit value minus the Baseline value. Baseline total iron 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.
Measured: Baseline, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)
Change From Baseline in Unsaturated Iron Binding Capacity at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)
Change from Baseline was calculated as the visit value minus the Baseline value. Baseline Unsaturated Iron Binding Capacity 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.
Measured: Baseline, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)
Change From Baseline in Iron Saturation at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)
Change from Baseline was calculated as the visit value minus the Baseline value. Baseline iron saturation 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.
Measured: Baseline, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)
Change From Baseline in Total Iron Binding Capacity (TIBC) at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)
Change from Baseline was calculated as the visit value minus the Baseline value. Baseline TIBC 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.
Measured: Baseline, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)
Change From Baseline in Ferritin at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)
Change from Baseline was calculated as the visit value minus the Baseline value. Baseline ferritin 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.
Measured: Baseline, Week 2, Week 4, Week 6, Follow-up (up to Week 8)
Change From Baseline in Erythropoietin at Week 2, Week 6, and Follow-up Visit (up to Week 8)
Change from Baseline was calculated as the visit value minus the Baseline value. Baseline erythropoietin 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.
Measured: Baseline, Week 2, Week 6, Follow-up Visit (up to Week 8)
Change From Baseline in Hepcidin at Week 6
Change from Baseline was calculated as the Week 6 value minus the Baseline value. Baseline hepcidin 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.
Measured: Baseline, Week 6
Mean Plasma Vadadustat Concentrations on Week 2 and Week 4
Plasma samples were collected for the analysis.
Measured: Week 2: Pre-dose and post-dose; Week 4: Pre-dose
Mean Plasma Vadadustat Acyl-Glucuronide Concentrations on Week 2 and Week 4
Plasma samples were collected for the analysis.
Measured: Week 2: Pre-dose; Week 4: Pre-dose
Number of Participants Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. A TEAE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. A SAE included AEs that met one or more of the following criteria/outcomes: death, life-threatening, in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, and congenital anomaly/birth defect.
Measured: Up to Week 8 (Follow-up Visit 2 weeks after last dose)
Number of Participants With Clinically Significant Changes From Baseline in Vital Signs Parameter
Parameters assessed for vital signs included sitting blood pressure, pulse, respiratory rate, and body temperature. The investigator was responsible for reviewing laboratory results for clinically significant changes.
Measured: Up to Week 8 (Follow-up Visit 2 weeks after last dose)
Number of Participants With Clinically Significant Abnormal 12-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. Clinical significance is determined by the investigator. The investigator was responsible for reviewing laboratory results for clinical significance.
Measured: Up to Week 8 (Follow-up Visit 2 weeks after last dose)
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: Baseline, Week 6
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values
Parameters assessed for laboratory values included hematology, serum chemistry, C-reactive protein, DHEA-S, VEGF, and cystatin C. The investigator was responsible for reviewing laboratory results for clinically significant changes.
Measured: Up to Week 8 (Follow-up Visit 2 weeks after last dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study start15 Jun 2011
- Primary completion16 Feb 2012
- Study completion16 Feb 2012
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.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 93 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
- NCT01381094
- Sponsor's protocol ID
- AKB-6548-CI-0005
- Status last verified
- Jun 2022
- First submitted
- 23 Jun 2011
- Last updated
- 1 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
PubMed 36005278Martin ER, Smith MT, Maroni BJ, Zuraw QC, deGoma EM. Clinical Trial of Vadadustat in Patients with Anemia Secondary to Stage 3 or 4 Chronic Kidney Disease. Am J Nephrol. 2017;45(5):380-388. doi: 10.1159/000464476. Epub 2017 Mar 25.
PubMed 28343225
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 Randomized, Double-Blind, Placebo-Controlled, Dose Range Study to Assess the Pharmacodynamic Response, Pharmacokinetics, Safety, and Tolerability of 42-Day Repeat Oral Doses of AKB-6548 in Subjects With Anemia Secondary to Chronic Kidney Disease (CKD), Stages 3 and 4
- ClinicalTrials.gov ID
- NCT01381094
- Acronym / sponsor ID
- AKB-6548-CI-0005
- 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
- 93 participants (actual)
- Lead sponsor
- Akebia TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2011 (actual)
- Primary completion
- 16 Feb 2012 (actual)
- Study completion
- 16 Feb 2012 (actual)
- First posted
- 27 Jun 2011 (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 dose response (efficacy), pharmacodynamic response, pharmacokinetics, safety, and tolerability of orally administered AKB-6548 in pre-dialysis participants with anemia with repeat dosing for 42 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| AKB-6548 240 mg | Experimental | Drug: AKB-6548 |
| AKB-6548 370 mg | Experimental | Drug: AKB-6548 |
| AKB-6548 500 mg | Experimental | Drug: AKB-6548 |
| AKB-6548 630 mg | Experimental | Drug: AKB-6548 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 to 79 years of age, inclusive
- Chronic Kidney Disease (eGFR <60 mL/min), not yet on dialysis
- Hemoglobin (Hgb) ≤ 10.5 g/dL
- Transferring saturation ≥ 20%
- Ferritin ≥ 50 ng/mL
Key exclusion criteria (12 listed)
- Body mass index >42
- 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 11 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-6548oral dose administered once daily for 42 days | Drug | AKB-6548 240 mg, AKB-6548 370 mg, AKB-6548 500 mg, AKB-6548 630 mg |
| Placebooral Placebo administered once daily for 42 days | Drug | Placebo |
Primary outcome
Absolute Change From Baseline in Hemoglobin (Hgb) to End of Treatment (Week 6)
Time frame: 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.
28 secondary outcomes
Change From Baseline in Hgb at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)
Time frame: Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)
Change From Baseline in Hematocrit (HCT) at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)
Time frame: Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)
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)
Time frame: Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)
Change From Baseline in Absolute Reticulocyte Count at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)
Time frame: Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)
Change From Baseline in Reticulocyte Hgb Content at Week 6
Time frame: Baseline, Week 6
Maximum Change From Baseline in Hgb
Time frame: Baseline; up to Week 8
Maximum Change From Baseline in HCT
Time frame: Baseline; up to Week 8
Maximum Change From Baseline in RBC Count
Time frame: Baseline; up to Week 8
Maximum Change in Absolute Reticulocyte Count From Baseline
Time frame: Baseline; up to Week 8
Number of Participants With Absolute Change From Baseline in Hgb ≥ 0.4, 0.6, 0.8, and 1.0 g/dL at the End of Dosing Period
Time frame: Up to Week 6 (End of the Dosing Period)
Number of Participants With Change From Baseline in Hgb ≥5.0, 7.5, and 10.0% by the End of Dosing Period
Time frame: Up to Week 6 (End of The Dosing Period)
Number of Participants With Change From Baseline in HCT ≥5.0, 7.5, and 10.0% by the End of Dosing Period
Time frame: Up to Week 6 (End of The Dosing Period)
Number of Participants With Change From Baseline in RBC Count ≥5.0, 7.5, and 10.0% by the End of Dosing Period
Time frame: Up to Week 6 (End of The Dosing Period)
Number of Participants With Change From Baseline in Reticulocyte Count ≥6000, 12000, and 18000 Cells/uL by the End of Dosing Period
Time frame: Up to Week 6 (End of The Dosing Period)
Change From Baseline in Total Iron at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)
Time frame: Baseline, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)
Change From Baseline in Unsaturated Iron Binding Capacity at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)
Time frame: Baseline, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)
Change From Baseline in Iron Saturation at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)
Time frame: Baseline, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)
Change From Baseline in Total Iron Binding Capacity (TIBC) at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)
Time frame: Baseline, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)
Change From Baseline in Ferritin at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)
Time frame: Baseline, Week 2, Week 4, Week 6, Follow-up (up to Week 8)
Change From Baseline in Erythropoietin at Week 2, Week 6, and Follow-up Visit (up to Week 8)
Time frame: Baseline, Week 2, Week 6, Follow-up Visit (up to Week 8)
Change From Baseline in Hepcidin at Week 6
Time frame: Baseline, Week 6
Mean Plasma Vadadustat Concentrations on Week 2 and Week 4
Time frame: Week 2: Pre-dose and post-dose; Week 4: Pre-dose
Mean Plasma Vadadustat Acyl-Glucuronide Concentrations on Week 2 and Week 4
Time frame: Week 2: Pre-dose; Week 4: Pre-dose
Number of Participants Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to Week 8 (Follow-up Visit 2 weeks after last dose)
Number of Participants With Clinically Significant Changes From Baseline in Vital Signs Parameter
Time frame: Up to Week 8 (Follow-up Visit 2 weeks after last dose)
Number of Participants With Clinically Significant Abnormal 12-Electrocardiogram (ECG) Findings
Time frame: Up to Week 8 (Follow-up Visit 2 weeks after last dose)
Mean Change From Baseline in PR Interval, QT Interval, QRS Interval, and QT Corrected (QTc) Interval
Time frame: Baseline, Week 6
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values
Time frame: Up to Week 8 (Follow-up Visit 2 weeks after last dose)
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.
- Derived from this study: PubMed 36005278Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
- Derived from this study: PubMed 28343225Martin ER, Smith MT, Maroni BJ, Zuraw QC, deGoma EM. Clinical Trial of Vadadustat in Patients with Anemia Secondary to Stage 3 or 4 Chronic Kidney Disease. Am J Nephrol. 2017;45(5):380-388. doi: 10.1159/000464476. Epub 2017 Mar 25.
- 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
28 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 28 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 5 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 28 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. Some participants in this study may receive a placebo. 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?
Absolute Change From Baseline in Hemoglobin (Hgb) to End of Treatment (Week 6) (time frame: Baseline, Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01381094, which also lists 2 linked publications.
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.