- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01906489
20-Week Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
July 12, 2022 updated by: Akebia Therapeutics
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
210
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Glendale, Arizona, United States
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Tucson, Arizona, United States
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California
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Azusa, California, United States
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Chula Vista, California, United States
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Downey, California, United States
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El Centro, California, United States
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La Mesa, California, United States
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Long Beach, California, United States
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Riverside, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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Colorado
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Arvada, Colorado, United States
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Westminster, Colorado, United States
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Florida
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Lauderdale Lakes, Florida, United States
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Port Charlotte, Florida, United States
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Tampa, Florida, United States
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Georgia
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Augusta, Georgia, United States
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Macon, Georgia, United States
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Idaho
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Meridian, Idaho, United States
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Illinois
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Evergreen Park, Illinois, United States
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Louisiana
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Lafayette, Louisiana, United States
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Shreveport, Louisiana, United States
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Michigan
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Detroit, Michigan, United States
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Lansing, Michigan, United States
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Petoskey, Michigan, United States
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Pontiac, Michigan, United States
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Missouri
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Farmington, Missouri, United States
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Kansas City, Missouri, United States
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Nevada
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Las Vegas, Nevada, United States
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New Mexico
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Albuquerque, New Mexico, United States
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New York
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Flushing, New York, United States
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Mineola, New York, United States
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New Rochelle, New York, United States
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Rosedale, New York, United States
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North Carolina
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Asheville, North Carolina, United States
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Charlotte, North Carolina, United States
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Rocky Mount, North Carolina, United States
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Wilmington, North Carolina, United States
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Ohio
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Cincinnati, Ohio, United States
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South Carolina
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Columbia, South Carolina, United States
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Tennessee
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Knoxville, Tennessee, United States
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Texas
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Arlington, Texas, United States
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Austin, Texas, United States
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Edinburg, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Utah
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Saint George, Utah, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 82 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
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Oral Placebo administered once daily for 20 weeks.
Dose adjustment based on hemoglobin level as defined in the protocol.
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Experimental: AKB-6548
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Oral dose administered once daily for 20 weeks.
Dose adjustment based on hemoglobin level as defined in the protocol.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving a Successful Hemoglobin Response
Time Frame: Weeks 19 and 20
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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.
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Weeks 19 and 20
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Hemoglobin Value ≥13.0 g/dL at Any Time During the Study
Time Frame: Up to 20 Weeks
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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.
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Up to 20 Weeks
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Percentage of Participants Achieving a Successful Hemoglobin Response, Determined Solely Based on the Hemoglobin Value
Time Frame: Weeks 19 and 20
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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.
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Weeks 19 and 20
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Percentage of Participants Achieving a Successful Hemoglobin Response in ESA Treatment naïve Group
Time Frame: Weeks 19 and 20
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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.
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Weeks 19 and 20
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Percentage of Participants Achieving a Successful Hemoglobin Response in ESA Previously Treated Group
Time Frame: Weeks 19 and 20
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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.
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Weeks 19 and 20
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Percentage of Participants Achieving a Successful Hemoglobin Response in ESA Actively Treated Group
Time Frame: Weeks 19 and 20
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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.
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Weeks 19 and 20
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Percentage of Participants Achieving a Successful Hemoglobin Response, Analyzed in mITT Population
Time Frame: Weeks 19 and 20
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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.
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Weeks 19 and 20
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Change From Baseline in Hemoglobin
Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20
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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.
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Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20
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Absolute Values of Hemoglobin
Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20
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Blood samples were collected at indicated time points for analysis of hemoglobin
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Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20
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Change From Baseline in Hematocrit
Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20
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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.
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Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20
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Absolute Values of Hematocrit
Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20
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Blood samples were collected at indicated time points for analysis of Hematocrit.
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Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20
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Change From Baseline in Red Blood Cell Count
Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20
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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.
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Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20
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Absolute Values 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
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Blood samples were collected at indicated time points for analysis of red blood cell count.
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Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20
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Change From Baseline in Reticulocyte Count
Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20
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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.
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Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20
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Absolute Values of Reticulocyte Count
Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20
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Blood samples were collected at indicated time points for analysis of reticulocyte count.
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Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20
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Percentage of Participants Who Received ESA Rescue
Time Frame: Up to 20 Weeks
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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.
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Up to 20 Weeks
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Mean Number of ESA Rescue Doses Administered Per Participant
Time Frame: Up to 20 Weeks
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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.
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Up to 20 Weeks
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Percentage of Participants Who Received Packed Red Blood Cell Transfusion Rescue
Time Frame: Up to 20 Weeks
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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
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Up to 20 Weeks
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Number of Packed Red Blood Cell Transfusion Administered Per Participant
Time Frame: Up to 20 Weeks
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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.
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Up to 20 Weeks
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Time to First Transfusion or ESA Rescue Medication Intake
Time Frame: Up to 20 Weeks
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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.
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Up to 20 Weeks
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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs)
Time Frame: Up to 20 Weeks
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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.
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Up to 20 Weeks
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Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values
Time Frame: Up to 20 Weeks
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Parameters assessed for laboratory values included hematology, serum chemistry, and urinalysis.
The investigator was responsible for reviewing laboratory results for clinically significant changes.
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Up to 20 Weeks
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Number of Participants With Clinically Significant Changes From Baseline in Vital Signs
Time Frame: Up to 20 Weeks
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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.
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Up to 20 Weeks
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Number of Participants With Clinically Abnormal 12-Lead Electrocardiogram (ECG) Findings
Time Frame: Up to 20 Weeks
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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.
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Up to 20 Weeks
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Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Findings
Time Frame: Up to 20 Weeks
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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.
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Up to 20 Weeks
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Exploratory: Change From Baseline in Iron and Total Iron Binding Capacity (TIBC)
Time Frame: Baseline and up to Week 20
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Baseline and up to Week 20
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Exploratory: Change From Baseline in Transferrin
Time Frame: Baseline and up to Week 20
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Baseline and up to Week 20
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Exploratory: Change From Baseline in Transferrin Saturation
Time Frame: Baseline and up to Week 20
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Baseline and up to Week 20
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Exploratory: Mean Weekly Dose of Intravenous Elemental Iron Administered
Time Frame: Baseline and up to Week 20
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Baseline and up to Week 20
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Exploratory: Absolute Values of Iron and Total Iron Binding Capacity (TIBC)
Time Frame: Baseline and up to Week 20
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Baseline and up to Week 20
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Exploratory: Absolute Values of Transferrin
Time Frame: Baseline and up to Week 20
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Baseline and up to Week 20
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Exploratory: Absolute Values of Transferrin Saturation
Time Frame: Baseline and up to Week 20
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Baseline and up to Week 20
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Exploratory: Absolute Values of Reticulocyte Hemoglobin Content
Time Frame: Baseline and up to Week 20
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Baseline and up to Week 20
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Exploratory: Change From Baseline in Reticulocyte Hemoglobin Content
Time Frame: Baseline and up to Week 20
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Baseline and up to Week 20
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Exploratory: Change From Baseline in Hemoglobin A1c
Time Frame: Baseline and up to Week 20
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Baseline and up to Week 20
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Exploratory: Absolute Values of Hemoglobin A1c
Time Frame: Baseline and up to Week 20
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Baseline and up to Week 20
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Exploratory: Absolute Values of Lipids
Time Frame: Baseline and up to Week 20
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Baseline and up to Week 20
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Exploratory: Change From Baseline in Lipids
Time Frame: Baseline and up to Week 20
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Baseline and up to Week 20
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Exploratory: Change From Baseline in Hepcidin
Time Frame: Baseline and up to Week 20
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Baseline and up to Week 20
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Exploratory: Absolute Values of Hepcidin
Time Frame: Baseline and up to Week 20
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Baseline and up to Week 20
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Exploratory: Change From Baseline in Vascular Endothelial Growth Factor (VEGF)
Time Frame: Baseline and up to Week 20
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Baseline and up to Week 20
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Exploratory: Absolute Values of Interleukin 6, Cystatin C, Intact Parathyroid Hormone, and Calcitonin
Time Frame: Baseline and up to Week 20
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Baseline and up to Week 20
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Exploratory: Change From Baseline in Interleukin 6, Cystatin C, Intact Parathyroid Hormone, and Calcitonin
Time Frame: Baseline and up to Week 20
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Baseline and up to Week 20
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Exploratory: Neurocognitive Functioning as a Measure
Time Frame: Baseline and up to Week 20
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Baseline and up to Week 20
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Exploratory: Patient-Reported Outcome Measures
Time Frame: Baseline and up to Week 20
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Baseline and up to Week 20
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Exploratory: Plasma Concentrations of Vadadustat and Its Glucuronide Metabolites
Time Frame: Baseline and up to Week 20
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Baseline and up to Week 20
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Exploratory: Plasma Concentrations of Vadadustat and Its Glucuronide Metabolites
Time Frame: Baseline
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 23, 2013
Primary Completion (Actual)
September 3, 2014
Study Completion (Actual)
September 3, 2014
Study Registration Dates
First Submitted
July 20, 2013
First Submitted That Met QC Criteria
July 20, 2013
First Posted (Estimate)
July 24, 2013
Study Record Updates
Last Update Posted (Actual)
July 21, 2022
Last Update Submitted That Met QC Criteria
July 12, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AKB-6548-CI-0007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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