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20-Week Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia

Primary Purpose

Anemia, Chronic Kidney Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AKB-6548
Placebo
Sponsored by
Akebia Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

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, kidney, oral anemia treatment, hemoglobin, hypoxia-inducible factor, HIF, hypoxia-inducible factor prolyl-hydroxylase inhibitor, HIF-PHI, efficacy, safety, pharmacokinetics

Eligibility Criteria

18 Years - 82 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • 18 to 82 years of age, inclusive
  • Chronic Kidney Disease with a GFR category of G3a-G5 and not yet on dialysis
  • eGFR ≥ 10 and ≤ 65 mL/minute/1.73 m2
  • Anemia secondary to CKD with an ESA status and a Screening HGB as per protocol
  • Iron replete with ferritin and TSAT levels as defined per protocol

Key Exclusion Criteria:

  • BMI > 44.0 kg/m2
  • Red blood cell transfusion within 11 weeks prior to the Screening visit
  • Androgen therapy within the previous 21 days prior to the Screening visit
  • Intravenous iron within the past 4 weeks prior to the Screening visit
  • AST or ALT >1.8x ULN, alkaline phosphatase >2x ULN, or total bilirubin >1.5x ULN
  • Screening ECG with QTc > 500 msec
  • Uncontrolled hypertension
  • Class III or IV congestive heart failure
  • Myocardial infarction, acute coronary syndrome, or stroke within 6 months prior to the Screening visit

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AKB-6548

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving a Successful Hemoglobin Response
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 Outcome Measures

Percentage of Participants With Hemoglobin Value ≥13.0 g/dL at Any Time During the Study
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.
Percentage of Participants Achieving a Successful Hemoglobin Response, Determined Solely Based on the Hemoglobin Value
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.
Percentage of Participants Achieving a Successful Hemoglobin Response in ESA Treatment naïve Group
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.
Percentage of Participants Achieving a Successful Hemoglobin Response in ESA Previously Treated Group
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.
Percentage of Participants Achieving a Successful Hemoglobin Response in ESA Actively Treated Group
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.
Percentage of Participants Achieving a Successful Hemoglobin Response, Analyzed in mITT Population
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.
Change From Baseline in Hemoglobin
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.
Absolute Values of Hemoglobin
Blood samples were collected at indicated time points for analysis of hemoglobin
Change From Baseline in Hematocrit
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.
Absolute Values of Hematocrit
Blood samples were collected at indicated time points for analysis of Hematocrit.
Change From Baseline in Red Blood Cell Count
Blood samples were collected to assess red blood cell count. 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 red blood cell count increased.
Absolute Values of Red Blood Cell Count
Blood samples were collected at indicated time points for analysis of red blood cell count.
Change From Baseline in Reticulocyte Count
Blood samples were collected to assess reticulocyte count. Baseline was defined as 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 reticulocyte count increased.
Absolute Values of Reticulocyte Count
Blood samples were collected at indicated time points for analysis of reticulocyte count.
Percentage of Participants Who Received ESA Rescue
Participants were administered epoetin alfa or darbepoetin alfa as a rescue medication who met the Hgb rescue criteria in addition to having experienced a clinically significant worsening of their anemia or the symptoms of anemia.
Mean Number of ESA Rescue Doses Administered Per Participant
Participants were administered epoetin alfa or darbepoetin alfa as a rescue medication who have met the Hgb rescue criteria in addition to having experienced a clinically significant worsening of their anemia or the symptoms of anemia.
Percentage of Participants Who Received Packed Red Blood Cell Transfusion Rescue
Participants were administered packed red blood cell transfusion as a rescue medication who have met the Hgb rescue criteria in addition to having experienced a clinically significant worsening of their anemia or the symptoms of anemia
Number of Packed Red Blood Cell Transfusion Administered Per Participant
Participants were administered packed red blood cells as a rescue medication who have met the Hgb rescue criteria in addition to having experienced a clinically significant worsening of their anemia or the symptoms of anemia.
Time to First Transfusion or ESA Rescue Medication Intake
Rescue therapy was defined as red blood cell transfusion or ESA administration in participants meeting Hgb rescue criteria in addition to having experienced a clinically significant worsening of their anemia or the symptoms of anemia.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs)
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.
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values
Parameters assessed for laboratory values included hematology, serum chemistry, and urinalysis. The investigator was responsible for reviewing laboratory results for clinically significant changes.
Number of Participants With Clinically Significant Changes From Baseline in Vital Signs
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.
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.
Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Findings
A Baseline physical examination was performed at screening. Otherwise, abbreviated physical examinations were conducted and were to include heart, lung, and abdomen. The investigator was responsible for reviewing laboratory results for clinically significant changes.

Full Information

First Posted
July 20, 2013
Last Updated
July 12, 2022
Sponsor
Akebia Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01906489
Brief Title
20-Week Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
Official Title
Phase 2b Randomized, Double-Blind, Placebo-Controlled Study to Assess the Pharmacodynamic Response, Safety, and Tolerability to 20 Weeks of Oral Dosing of AKB-6548 in Participants With Anemia Secondary to Chronic Kidney Disease (CKD), GFR Categories G3a-G5 (Stages 3, 4, AND 5) (Pre-Dialysis)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
July 23, 2013 (Actual)
Primary Completion Date
September 3, 2014 (Actual)
Study Completion Date
September 3, 2014 (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 hemoglobin response (efficacy), safety, and tolerability of orally administered AKB-6548 in participants with Chronic Kidney Disease (pre-dialysis) with anemia with dosing for 20 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Chronic Kidney Disease
Keywords
anemia, chronic kidney disease, CKD, chronic renal insufficiency, renal impairment, erythropoietin, kidney, oral anemia treatment, hemoglobin, hypoxia-inducible factor, HIF, hypoxia-inducible factor prolyl-hydroxylase inhibitor, HIF-PHI, efficacy, safety, pharmacokinetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AKB-6548
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 20 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral Placebo administered once daily for 20 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving a Successful Hemoglobin Response
Description
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.
Time Frame
Weeks 19 and 20
Secondary Outcome Measure Information:
Title
Percentage of Participants With Hemoglobin Value ≥13.0 g/dL at Any Time During the Study
Description
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.
Time Frame
Up to 20 Weeks
Title
Percentage of Participants Achieving a Successful Hemoglobin Response, Determined Solely Based on the Hemoglobin Value
Description
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.
Time Frame
Weeks 19 and 20
Title
Percentage of Participants Achieving a Successful Hemoglobin Response in ESA Treatment naïve Group
Description
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.
Time Frame
Weeks 19 and 20
Title
Percentage of Participants Achieving a Successful Hemoglobin Response in ESA Previously Treated Group
Description
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.
Time Frame
Weeks 19 and 20
Title
Percentage of Participants Achieving a Successful Hemoglobin Response in ESA Actively Treated Group
Description
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.
Time Frame
Weeks 19 and 20
Title
Percentage of Participants Achieving a Successful Hemoglobin Response, Analyzed in mITT Population
Description
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.
Time Frame
Weeks 19 and 20
Title
Change From Baseline in Hemoglobin
Description
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.
Time Frame
Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20
Title
Absolute Values of Hemoglobin
Description
Blood samples were collected at indicated time points for analysis of hemoglobin
Time Frame
Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20
Title
Change From Baseline in Hematocrit
Description
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.
Time Frame
Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20
Title
Absolute Values of Hematocrit
Description
Blood samples were collected at indicated time points for analysis of Hematocrit.
Time Frame
Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20
Title
Change From Baseline in Red Blood Cell Count
Description
Blood samples were collected to assess red blood cell count. 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 red blood cell count increased.
Time Frame
Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20
Title
Absolute Values of Red Blood Cell Count
Description
Blood samples were collected at indicated time points for analysis of red blood cell count.
Time Frame
Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20
Title
Change From Baseline in Reticulocyte Count
Description
Blood samples were collected to assess reticulocyte count. Baseline was defined as 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 reticulocyte count increased.
Time Frame
Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20
Title
Absolute Values of Reticulocyte Count
Description
Blood samples were collected at indicated time points for analysis of reticulocyte count.
Time Frame
Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20
Title
Percentage of Participants Who Received ESA Rescue
Description
Participants were administered epoetin alfa or darbepoetin alfa as a rescue medication who met the Hgb rescue criteria in addition to having experienced a clinically significant worsening of their anemia or the symptoms of anemia.
Time Frame
Up to 20 Weeks
Title
Mean Number of ESA Rescue Doses Administered Per Participant
Description
Participants were administered epoetin alfa or darbepoetin alfa as a rescue medication who have met the Hgb rescue criteria in addition to having experienced a clinically significant worsening of their anemia or the symptoms of anemia.
Time Frame
Up to 20 Weeks
Title
Percentage of Participants Who Received Packed Red Blood Cell Transfusion Rescue
Description
Participants were administered packed red blood cell transfusion as a rescue medication who have met the Hgb rescue criteria in addition to having experienced a clinically significant worsening of their anemia or the symptoms of anemia
Time Frame
Up to 20 Weeks
Title
Number of Packed Red Blood Cell Transfusion Administered Per Participant
Description
Participants were administered packed red blood cells as a rescue medication who have met the Hgb rescue criteria in addition to having experienced a clinically significant worsening of their anemia or the symptoms of anemia.
Time Frame
Up to 20 Weeks
Title
Time to First Transfusion or ESA Rescue Medication Intake
Description
Rescue therapy was defined as red blood cell transfusion or ESA administration in participants meeting Hgb rescue criteria in addition to having experienced a clinically significant worsening of their anemia or the symptoms of anemia.
Time Frame
Up to 20 Weeks
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs)
Description
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.
Time Frame
Up to 20 Weeks
Title
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values
Description
Parameters assessed for laboratory values included hematology, serum chemistry, and urinalysis. The investigator was responsible for reviewing laboratory results for clinically significant changes.
Time Frame
Up to 20 Weeks
Title
Number of Participants With Clinically Significant Changes From Baseline in Vital Signs
Description
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.
Time Frame
Up to 20 Weeks
Title
Number of Participants With Clinically Abnormal 12-Lead 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. The investigator was responsible for reviewing laboratory results for clinical significance.
Time Frame
Up to 20 Weeks
Title
Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Findings
Description
A Baseline physical examination was performed at screening. Otherwise, abbreviated physical examinations were conducted and were to include heart, lung, and abdomen. The investigator was responsible for reviewing laboratory results for clinically significant changes.
Time Frame
Up to 20 Weeks
Other Pre-specified Outcome Measures:
Title
Exploratory: Change From Baseline in Iron and Total Iron Binding Capacity (TIBC)
Time Frame
Baseline and up to Week 20
Title
Exploratory: Change From Baseline in Transferrin
Time Frame
Baseline and up to Week 20
Title
Exploratory: Change From Baseline in Transferrin Saturation
Time Frame
Baseline and up to Week 20
Title
Exploratory: Mean Weekly Dose of Intravenous Elemental Iron Administered
Time Frame
Baseline and up to Week 20
Title
Exploratory: Absolute Values of Iron and Total Iron Binding Capacity (TIBC)
Time Frame
Baseline and up to Week 20
Title
Exploratory: Absolute Values of Transferrin
Time Frame
Baseline and up to Week 20
Title
Exploratory: Absolute Values of Transferrin Saturation
Time Frame
Baseline and up to Week 20
Title
Exploratory: Absolute Values of Reticulocyte Hemoglobin Content
Time Frame
Baseline and up to Week 20
Title
Exploratory: Change From Baseline in Reticulocyte Hemoglobin Content
Time Frame
Baseline and up to Week 20
Title
Exploratory: Change From Baseline in Hemoglobin A1c
Time Frame
Baseline and up to Week 20
Title
Exploratory: Absolute Values of Hemoglobin A1c
Time Frame
Baseline and up to Week 20
Title
Exploratory: Absolute Values of Lipids
Time Frame
Baseline and up to Week 20
Title
Exploratory: Change From Baseline in Lipids
Time Frame
Baseline and up to Week 20
Title
Exploratory: Change From Baseline in Hepcidin
Time Frame
Baseline and up to Week 20
Title
Exploratory: Absolute Values of Hepcidin
Time Frame
Baseline and up to Week 20
Title
Exploratory: Change From Baseline in Vascular Endothelial Growth Factor (VEGF)
Time Frame
Baseline and up to Week 20
Title
Exploratory: Absolute Values of Interleukin 6, Cystatin C, Intact Parathyroid Hormone, and Calcitonin
Time Frame
Baseline and up to Week 20
Title
Exploratory: Change From Baseline in Interleukin 6, Cystatin C, Intact Parathyroid Hormone, and Calcitonin
Time Frame
Baseline and up to Week 20
Title
Exploratory: Neurocognitive Functioning as a Measure
Time Frame
Baseline and up to Week 20
Title
Exploratory: Patient-Reported Outcome Measures
Time Frame
Baseline and up to Week 20
Title
Exploratory: Plasma Concentrations of Vadadustat and Its Glucuronide Metabolites
Time Frame
Baseline and up to Week 20
Title
Exploratory: Plasma Concentrations of Vadadustat and Its Glucuronide Metabolites
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
82 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 18 to 82 years of age, inclusive Chronic Kidney Disease with a GFR category of G3a-G5 and not yet on dialysis eGFR ≥ 10 and ≤ 65 mL/minute/1.73 m2 Anemia secondary to CKD with an ESA status and a Screening HGB as per protocol Iron replete with ferritin and TSAT levels as defined per protocol Key Exclusion Criteria: BMI > 44.0 kg/m2 Red blood cell transfusion within 11 weeks prior to the Screening visit Androgen therapy within the previous 21 days prior to the Screening visit Intravenous iron within the past 4 weeks prior to the Screening visit AST or ALT >1.8x ULN, alkaline phosphatase >2x ULN, or total bilirubin >1.5x ULN Screening ECG with QTc > 500 msec Uncontrolled hypertension Class III or IV congestive heart failure Myocardial infarction, acute coronary syndrome, or stroke within 6 months prior to the Screening visit
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
Glendale
State/Province
Arizona
Country
United States
City
Tucson
State/Province
Arizona
Country
United States
City
Azusa
State/Province
California
Country
United States
City
Chula Vista
State/Province
California
Country
United States
City
Downey
State/Province
California
Country
United States
City
El Centro
State/Province
California
Country
United States
City
La Mesa
State/Province
California
Country
United States
City
Long Beach
State/Province
California
Country
United States
City
Riverside
State/Province
California
Country
United States
City
Sacramento
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Arvada
State/Province
Colorado
Country
United States
City
Westminster
State/Province
Colorado
Country
United States
City
Lauderdale Lakes
State/Province
Florida
Country
United States
City
Port Charlotte
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Augusta
State/Province
Georgia
Country
United States
City
Macon
State/Province
Georgia
Country
United States
City
Meridian
State/Province
Idaho
Country
United States
City
Evergreen Park
State/Province
Illinois
Country
United States
City
Lafayette
State/Province
Louisiana
Country
United States
City
Shreveport
State/Province
Louisiana
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
Lansing
State/Province
Michigan
Country
United States
City
Petoskey
State/Province
Michigan
Country
United States
City
Pontiac
State/Province
Michigan
Country
United States
City
Farmington
State/Province
Missouri
Country
United States
City
Kansas City
State/Province
Missouri
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Albuquerque
State/Province
New Mexico
Country
United States
City
Flushing
State/Province
New York
Country
United States
City
Mineola
State/Province
New York
Country
United States
City
New Rochelle
State/Province
New York
Country
United States
City
Rosedale
State/Province
New York
Country
United States
City
Asheville
State/Province
North Carolina
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Rocky Mount
State/Province
North Carolina
Country
United States
City
Wilmington
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Columbia
State/Province
South Carolina
Country
United States
City
Knoxville
State/Province
Tennessee
Country
United States
City
Arlington
State/Province
Texas
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Edinburg
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Saint George
State/Province
Utah
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
27650732
Citation
Pergola PE, Spinowitz BS, Hartman CS, Maroni BJ, Haase VH. Vadadustat, a novel oral HIF stabilizer, provides effective anemia treatment in nondialysis-dependent chronic kidney disease. Kidney Int. 2016 Nov;90(5):1115-1122. doi: 10.1016/j.kint.2016.07.019. Epub 2016 Sep 17.
Results Reference
derived

Learn more about this trial

20-Week Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia

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