16-Week Repeat Oral Dose Study of AKB-6548 for Anemia in Participants With End Stage Renal Disease (ESRD) Requiring Chronic Hemodialysis
Phase 2 Open-Label Study to Assess the Efficacy, Safety, and Tolerability of AKB-6548 in Subjects With Anemia Secondary to End Stage Renal Disease (ESRD), Undergoing Chronic Hemodialysis.
1 other identifier
interventional
94
1 country
16
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 end stage renal disease undergoing chronic hemodialysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2014
Shorter than P25 for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 10, 2014
CompletedFirst Submitted
Initial submission to the registry
September 25, 2014
CompletedFirst Posted
Study publicly available on registry
October 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 22, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 22, 2015
CompletedResults Posted
Study results publicly available
July 1, 2022
CompletedJuly 1, 2022
June 1, 2022
11 months
September 25, 2014
April 22, 2022
June 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change From Pre-dose Average in Hemoglobin (Hgb) Level to The Mid-study Average
Change from pre-dose average was calculated by the mid-study average minus the pre-dose average. The pre-dose average was defined as the average of the 3 Hgb values that were obtained before dosing at the first screening visit, the second screening visit, and the Baseline visit; the mid-study average was defined as the average of the 2 Hgb values that were obtained at the Week 7 and Week 8 visits.
Pre-dose (Screening, Second Screening, and Baseline), Week 7, and Week 8
Change From Pre-dose Average in Hgb Level to The End-of-study Average
Change from pre-dose average was calculated by the end-of-study average minus the pre-dose average. The pre-dose average was defined as the average of the 3 Hgb values that were obtained before dosing at the first screening visit, the second screening visit, and the Baseline visit; the end-of-study average was defined as the average of the 2 Hgb values that were obtained at the Week 15 and Week 16 visits.
Pre-dose, Week 15, and Week 16
Change From Mid-study Average in Hgb Level to The End-of-study Average
Change from mid-study average was calculated by the end-of-study average minus the mid-study average. The mid-study average was defined as the average of the 2 Hgb values that were obtained at the Week 7 and Week 8 visits; the end-of-study average was defined as the average of the 2 Hgb values that were obtained at the Week 15 and Week 16 visits.
Week 7, Week 8, Week 15, and Week 16
Secondary Outcomes (20)
Change From Baseline in Hgb
Baseline, Week 4, Week 8, Week 12, and Week 16
Change From Baseline in Hematocrit
Baseline, Week 4, Week 8, Week 12, and Week 16
Change From Baseline in Red Blood Cell (RBC) Count
Baseline, Week 4, Week 8, Week 12, and Week 16
Change From Baseline in Absolute Reticulocyte Count
Baseline, Week 4, Week 8, Week 12, and Week 16
Change From Baseline in Percent Reticulocyte Count
Baseline, Week 4, Week 8, Week 12, and Week 16
- +15 more secondary outcomes
Other Outcomes (1)
Mean Intravenous Iron Replacement Therapy
Baseline, Week 8, and Week 16
Study Arms (3)
AKB-6548, starting dose 1
EXPERIMENTALAKB-6548, starting dose 2
EXPERIMENTALAKB-6548, starting dose 3
EXPERIMENTALInterventions
Starting dose 1. Oral dose administered once daily for 16 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.
Eligibility Criteria
You may qualify if:
- to 79 years inclusive
- Chronic Kidney Disease (CKD) Stage 5 on chronic hemodialysis for at least 3 months
- Anemia secondary to CKD treated with erythropoiesis stimulating agent and intravenous iron
You may not qualify if:
- Body mass index \>44.0 kilograms per meter squared (kg/m\^2)
- Transfusion within 8 weeks prior to Screening
- Alanine transaminase or total bilirubin \>1.25x ULN
- Uncontrolled hypertension
- Class III or IV congestive heart failure
- Myocardial infarction, acute coronary syndrome, stroke or transient ischemic attack within 6 months prior to Screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Unknown Facility
El Granada, California, United States
Unknown Facility
Long Beach, California, United States
Unknown Facility
San Dimas, California, United States
Unknown Facility
Santa Clarita, California, United States
Unknown Facility
Whittier, California, United States
Unknown Facility
Arvada, Colorado, United States
Unknown Facility
Westminster, Colorado, United States
Unknown Facility
Naples, Florida, United States
Unknown Facility
North Miami Beach, Florida, United States
Unknown Facility
Augusta, Georgia, United States
Unknown Facility
Astoria, New York, United States
Unknown Facility
Arlington, Texas, United States
Unknown Facility
Grand Prairie, Texas, United States
Unknown Facility
Greenville, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Mechanicsville, Virginia, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Akebia Therapeutics, Inc.
- Organization
- Akebia Therapeutics, Inc.
Study Officials
- STUDY DIRECTOR
Chief Medical Officer
Akebia Therapeutics Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2014
First Posted
October 9, 2014
Study Start
September 10, 2014
Primary Completion
July 22, 2015
Study Completion
July 22, 2015
Last Updated
July 1, 2022
Results First Posted
July 1, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share