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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01906489
Recruitment Status : Completed
First Posted : July 24, 2013
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Akebia Therapeutics

Study Description
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Brief Summary:
The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and tolerability of orally administered AKB-6548 in patients with Chronic Kidney Disease (pre-dialysis) with anemia with dosing for 20 weeks.

Condition or disease Intervention/treatment Phase
Anemia Chronic Kidney Disease Drug: AKB-6548 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Subjects With Anemia Secondary to Chronic Kidney Disease (CKD), GFR Categories G3a-G5 (Stages 3, 4, AND 5) (Pre-Dialysis)
Study Start Date : July 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: AKB-6548 Drug: AKB-6548
Oral dose administered once daily for 20 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.
Placebo Comparator: Placebo Drug: Placebo
Oral placebo administered once daily for 20 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.


Outcome Measures
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Primary Outcome Measures :
  1. Percent of subjects achieving or maintaining a hemoglobin response as defined in the protocol. [ Time Frame: 20 weeks ]

Secondary Outcome Measures :
  1. Analysis/reanalysis of the primary endpoint with regard to hemoglobin control, need for rescue, baseline hemoglobin, and protocol-defined study groups. [ Time Frame: 20 weeks ]
  2. Hematologic response to include actual values and change from baseline in hematologic parameters. [ Time Frame: 20 weeks ]
  3. Need for transfusion and/or ESA rescue. [ Time Frame: 20 weeks ]
  4. Safety and tolerability measures to include assessments of adverse events, vital signs, ECGs, and laboratory assay results. [ Time Frame: 20 weeks of therapy, 4 week follow-up ]

Other Outcome Measures:
  1. Iron metabolism to include actual values and change from baseline in iron indices. [ Time Frame: 20 weeks ]
  2. Iron utilization (both oral and intravenous). [ Time Frame: 20 weeks ]
  3. Concentration measurements of AKB-6548 and metabolites. [ Time Frame: Weeks 12 and 20 visits ]
  4. Neurocognitive and patient reported outcome measures. [ Time Frame: 20 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 82 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01906489


Locations
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United States, Arizona
Glendale, Arizona, United States
Tucson, Arizona, United States
United States, California
Azusa, California, United States
Chula Vista, California, United States
Downey, California, United States
El Centro, California, United States
La Mesa, California, United States
Long Beach, California, United States
Riverside, California, United States
Sacramento, California, United States
San Diego, California, United States
United States, Colorado
Arvada, Colorado, United States
Westminster, Colorado, United States
United States, Florida
Lauderdale Lakes, Florida, United States
Port Charlotte, Florida, United States
Tampa, Florida, United States
United States, Georgia
Augusta, Georgia, United States
Macon, Georgia, United States
United States, Idaho
Meridian, Idaho, United States
United States, Illinois
Evergreen Park, Illinois, United States
United States, Louisiana
Lafayette, Louisiana, United States
Shreveport, Louisiana, United States
United States, Michigan
Detroit, Michigan, United States
Lansing, Michigan, United States
Petoskey, Michigan, United States
Pontiac, Michigan, United States
United States, Missouri
Farmington, Missouri, United States
Kansas City, Missouri, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, New York
Flushing, New York, United States
Mineola, New York, United States
New Rochelle, New York, United States
Rosedale, New York, United States
United States, North Carolina
Asheville, North Carolina, United States
Charlotte, North Carolina, United States
Rocky Mount, North Carolina, United States
Wilmington, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, South Carolina
Columbia, South Carolina, United States
United States, Tennessee
Knoxville, Tennessee, United States
United States, Texas
Arlington, Texas, United States
Austin, Texas, United States
Edinburg, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
United States, Utah
Saint George, Utah, United States
Sponsors and Collaborators
Akebia Therapeutics
Investigators
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Study Director: Akebia Therapeutics Sponsor GmbH
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Akebia Therapeutics
ClinicalTrials.gov Identifier: NCT01906489    
Other Study ID Numbers: AKB-6548-CI-0007
First Posted: July 24, 2013    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Akebia Therapeutics:
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
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Anemia
 Hematologic Diseases
Urologic Diseases
Renal Insufficiency