Back to results42-Day Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
Primary Purpose
Anemia, Kidney Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AKB-6548
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Anemia focused on measuring anemia, chronic kidney disease, CKD, chronic renal insufficiency, renal impairment, erythropoietin, safety, efficacy, tolerability, pharmacokinetics
Eligibility Criteria
Key Inclusion Criteria:
- 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:
- 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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
AKB-6548 240 mg
AKB-6548 370 mg
AKB-6548 500 mg
AKB-6548 630 mg
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Mean Plasma Vadadustat Concentrations on Week 2 and Week 4
Plasma samples were collected for the analysis.
Mean Plasma Vadadustat Acyl-Glucuronide Concentrations on Week 2 and Week 4
Plasma samples were collected for the analysis.
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.
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.
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.
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).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01381094
Brief Title
42-Day Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 15, 2011 (Actual)
Primary Completion Date
February 16, 2012 (Actual)
Study Completion Date
February 16, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akebia Therapeutics
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Kidney Disease
Keywords
anemia, chronic kidney disease, CKD, chronic renal insufficiency, renal impairment, erythropoietin, safety, efficacy, tolerability, pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AKB-6548 240 mg
Arm Type
Experimental
Arm Title
AKB-6548 370 mg
Arm Type
Experimental
Arm Title
AKB-6548 500 mg
Arm Type
Experimental
Arm Title
AKB-6548 630 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AKB-6548
Intervention Description
oral dose administered once daily for 42 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral Placebo administered once daily for 42 days
Primary Outcome Measure Information:
Title
Absolute Change From Baseline in Hemoglobin (Hgb) to End of Treatment (Week 6)
Description
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.
Time Frame
Baseline, Week 6
Secondary Outcome Measure Information:
Title
Change From Baseline in Hgb at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)
Description
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.
Time Frame
Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)
Title
Change From Baseline in Hematocrit (HCT) at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)
Description
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.
Time Frame
Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)
Title
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)
Description
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.
Time Frame
Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)
Title
Change From Baseline in Absolute Reticulocyte Count at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)
Description
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.
Time Frame
Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)
Title
Change From Baseline in Reticulocyte Hgb Content at Week 6
Description
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.
Time Frame
Baseline, Week 6
Title
Maximum Change From Baseline in Hgb
Description
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.
Time Frame
Baseline; up to Week 8
Title
Maximum Change From Baseline in HCT
Description
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.
Time Frame
Baseline; up to Week 8
Title
Maximum Change From Baseline in RBC Count
Description
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.
Time Frame
Baseline; up to Week 8
Title
Maximum Change in Absolute Reticulocyte Count From Baseline
Description
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.
Time Frame
Baseline; up to Week 8
Title
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
Description
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.
Time Frame
Up to Week 6 (End of the Dosing Period)
Title
Number of Participants With Change From Baseline in Hgb ≥5.0, 7.5, and 10.0% by the End of Dosing Period
Description
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.
Time Frame
Up to Week 6 (End of The Dosing Period)
Title
Number of Participants With Change From Baseline in HCT ≥5.0, 7.5, and 10.0% by the End of Dosing Period
Description
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.
Time Frame
Up to Week 6 (End of The Dosing Period)
Title
Number of Participants With Change From Baseline in RBC Count ≥5.0, 7.5, and 10.0% by the End of Dosing Period
Description
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.
Time Frame
Up to Week 6 (End of The Dosing Period)
Title
Number of Participants With Change From Baseline in Reticulocyte Count ≥6000, 12000, and 18000 Cells/uL by the End of Dosing Period
Description
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.
Time Frame
Up to Week 6 (End of The Dosing Period)
Title
Change From Baseline in Total Iron at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)
Description
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.
Time Frame
Baseline, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)
Title
Change From Baseline in Unsaturated Iron Binding Capacity at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)
Description
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.
Time Frame
Baseline, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)
Title
Change From Baseline in Iron Saturation at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)
Description
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.
Time Frame
Baseline, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)
Title
Change From Baseline in Total Iron Binding Capacity (TIBC) at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)
Description
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.
Time Frame
Baseline, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)
Title
Change From Baseline in Ferritin at Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)
Description
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.
Time Frame
Baseline, Week 2, Week 4, Week 6, Follow-up (up to Week 8)
Title
Change From Baseline in Erythropoietin at Week 2, Week 6, and Follow-up Visit (up to Week 8)
Description
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.
Time Frame
Baseline, Week 2, Week 6, Follow-up Visit (up to Week 8)
Title
Change From Baseline in Hepcidin at Week 6
Description
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.
Time Frame
Baseline, Week 6
Title
Mean Plasma Vadadustat Concentrations on Week 2 and Week 4
Description
Plasma samples were collected for the analysis.
Time Frame
Week 2: Pre-dose and post-dose; Week 4: Pre-dose
Title
Mean Plasma Vadadustat Acyl-Glucuronide Concentrations on Week 2 and Week 4
Description
Plasma samples were collected for the analysis.
Time Frame
Week 2: Pre-dose; Week 4: Pre-dose
Title
Number of Participants Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
Up to Week 8 (Follow-up Visit 2 weeks after last dose)
Title
Number of Participants With Clinically Significant Changes From Baseline in Vital Signs Parameter
Description
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.
Time Frame
Up to Week 8 (Follow-up Visit 2 weeks after last dose)
Title
Number of Participants With Clinically Significant Abnormal 12-Electrocardiogram (ECG) Findings
Description
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.
Time Frame
Up to Week 8 (Follow-up Visit 2 weeks after last dose)
Title
Mean Change From Baseline in PR Interval, QT Interval, QRS Interval, and QT Corrected (QTc) Interval
Description
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).
Time Frame
Baseline, Week 6
Title
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values
Description
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.
Time Frame
Up to Week 8 (Follow-up Visit 2 weeks after last dose)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
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:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Medical Officer
Organizational Affiliation
Akebia Therapeutics Inc.
Official's Role
Study Director
Facility Information:
City
Pine Bluff
State/Province
Arkansas
Country
United States
City
Covina
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Lynwood
State/Province
California
Country
United States
City
Riverside
State/Province
California
Country
United States
City
San Dimas
State/Province
California
Country
United States
City
Whittier
State/Province
California
Country
United States
City
Coral Springs
State/Province
Florida
Country
United States
City
Lauderdale Lakes
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Ocala
State/Province
Florida
Country
United States
City
Augusta
State/Province
Georgia
Country
United States
City
Macon
State/Province
Georgia
Country
United States
City
Wichita
State/Province
Kansas
Country
United States
City
Shreveport
State/Province
Louisiana
Country
United States
City
Springfield
State/Province
Massachusetts
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
Pontiac
State/Province
Michigan
Country
United States
City
Warren
State/Province
Michigan
Country
United States
City
Bethpage
State/Province
New York
Country
United States
City
Mineola
State/Province
New York
Country
United States
City
Wilmington
State/Province
North Carolina
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Knoxville
State/Province
Tennessee
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Fort Worth
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36005278
Citation
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.
Results Reference
derived
PubMed Identifier
28343225
Citation
Martin 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.
Results Reference
derived
Learn more about this trial
42-Day Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
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