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42-Day 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: NCT01381094
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Akebia Therapeutics

Brief Summary:
The purpose of this study is to evaluate the dose response (efficacy), safety, and tolerability of orally administered AKB-6548 in pre-dialysis subjects with anemia with repeat dosing for 42 days.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AKB-6548 240 mg Drug: AKB-6548
oral dose administered once daily for 42 days

Experimental: AKB-6548 370 mg Drug: AKB-6548
oral dose administered once daily for 42 days

Experimental: AKB-6548 500 mg Drug: AKB-6548
oral dose administered once daily for 42 days

Experimental: AKB-6548 630 mg Drug: AKB-6548
oral dose administered once daily for 42 days

Placebo Comparator: Placebo Drug: Placebo
oral placebo administered once daily for 42 days




Primary Outcome Measures :
  1. Mean absolute change in hemoglobin. [ Time Frame: 42 days ]

Secondary Outcome Measures :
  1. Hematologic response to include rate of response, actual values, change from baseline, and maximum change in hematologic parameters. [ Time Frame: 42 days ]
  2. Safety and tolerability measures will include assessments of adverse events, vital signs, ECGs, physical exam findings, and laboratory assays (hematology and chemistry). [ Time Frame: 42 days of therapy, 2 week follow-up ]
  3. Pharmacokinetic assessment will involve both pre-dose and post-dose plasma concentration of AKB-6548. [ Time Frame: Weeks 2 and 4 visits ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • 18 to 79 years of age, inclusive
  • Chronic Kidney Disease (eGFR <60 mL/min), not yet on dialysis
  • Hemoglobin (Hgb) ≤ 10.5 g/dL
  • TSAT ≥ 20%
  • Ferritin ≥ 50 ng/mL

Key Exclusion Criteria:

  • BMI >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
  • Subjects 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
  • AST or ALT >1.8x 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

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): NCT01381094


Locations
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United States, Arkansas
Pine Bluff, Arkansas, United States
United States, California
Covina, California, United States
Los Angeles, California, United States
Lynwood, California, United States
Riverside, California, United States
San Dimas, California, United States
Whittier, California, United States
United States, Florida
Coral Springs, Florida, United States
Lauderdale Lakes, Florida, United States
Miami, Florida, United States
Ocala, Florida, United States
United States, Georgia
Augusta, Georgia, United States
Macon, Georgia, United States
United States, Kansas
Wichita, Kansas, United States
United States, Louisiana
Shreveport, Louisiana, United States
United States, Massachusetts
Springfield, Massachusetts, United States
United States, Michigan
Detroit, Michigan, United States
Pontiac, Michigan, United States
Warren, Michigan, United States
United States, New York
Bethpage, New York, United States
Mineola, New York, United States
United States, North Carolina
Wilmington, North Carolina, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Tennessee
Knoxville, Tennessee, United States
United States, Texas
Austin, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Sponsors and Collaborators
Akebia Therapeutics
Investigators
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Study Director: Akebia Therapeutics, MD Sponsor GmbH

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Akebia Therapeutics
ClinicalTrials.gov Identifier: NCT01381094    
Other Study ID Numbers: AKB-6548-CI-0005
First Posted: June 27, 2011    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
safety
efficacy
tolerability
pharmacokinetics
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Anemia
Hematologic Diseases
Urologic Diseases
Renal Insufficiency