42-Day Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
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
1 other identifier
interventional
93
1 country
28
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.
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 Jun 2011
Shorter than P25 for phase_2
28 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
June 15, 2011
CompletedFirst Submitted
Initial submission to the registry
June 23, 2011
CompletedFirst Posted
Study publicly available on registry
June 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 16, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 16, 2012
CompletedResults Posted
Study results publicly available
July 1, 2022
CompletedJuly 1, 2022
June 1, 2022
8 months
June 23, 2011
April 22, 2022
June 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline, Week 6
Secondary Outcomes (28)
Change From Baseline in Hgb at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)
Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)
Change From Baseline in Hematocrit (HCT) at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)
Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)
Change From Baseline in Red Blood Cell (RBC) Count at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)
Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)
Change From Baseline in Absolute Reticulocyte Count at Week 1, Week 2, Week 4, Week 6, and Follow-up Visit (up to Week 8)
Baseline, Week 1, Week 2, Week 4, Week 6, Follow-up Visit (up to Week 8)
Change From Baseline in Reticulocyte Hgb Content at Week 6
Baseline, Week 6
- +23 more secondary outcomes
Study Arms (5)
AKB-6548 240 mg
EXPERIMENTALAKB-6548 370 mg
EXPERIMENTALAKB-6548 500 mg
EXPERIMENTALAKB-6548 630 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Unknown Facility
Pine Bluff, Arkansas, United States
Unknown Facility
Covina, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Lynwood, California, United States
Unknown Facility
Riverside, California, United States
Unknown Facility
San Dimas, California, United States
Unknown Facility
Whittier, California, United States
Unknown Facility
Coral Springs, Florida, United States
Unknown Facility
Lauderdale Lakes, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Ocala, Florida, United States
Unknown Facility
Augusta, Georgia, United States
Unknown Facility
Macon, Georgia, United States
Unknown Facility
Wichita, Kansas, United States
Unknown Facility
Shreveport, Louisiana, United States
Unknown Facility
Springfield, Massachusetts, United States
Unknown Facility
Detroit, Michigan, United States
Unknown Facility
Pontiac, Michigan, United States
Unknown Facility
Warren, Michigan, United States
Unknown Facility
Bethpage, New York, United States
Unknown Facility
Mineola, New York, United States
Unknown Facility
Wilmington, North Carolina, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Knoxville, Tennessee, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Fort Worth, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Related Publications (2)
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.
PMID: 36005278DERIVEDMartin 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.
PMID: 28343225DERIVED
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
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2011
First Posted
June 27, 2011
Study Start
June 15, 2011
Primary Completion
February 16, 2012
Study Completion
February 16, 2012
Last Updated
July 1, 2022
Results First Posted
July 1, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share