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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Akebia Therapeutics
ClinicalTrials.gov Identifier:
NCT01381094
First received: June 23, 2011
Last updated: October 3, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Anemia
Kidney Disease
 Drug: AKB-6548
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Akebia Therapeutics:

Primary Outcome Measures:
  • Mean absolute change in hemoglobin. [ Time Frame: 42 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hematologic response to include rate of response, actual values, change from baseline, and maximum change in hematologic parameters. [ Time Frame: 42 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic assessment will involve both pre-dose and post-dose plasma concentration of AKB-6548. [ Time Frame: Weeks 2 and 4 visits ] [ Designated as safety issue: Yes ]

Enrollment: 93
Study Start Date: June 2011
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01381094

  Hide Study Locations
Locations
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
Study Chair: Robert Shalwitz, MD Akebia Therapeutics
  More Information

No publications provided

Responsible Party: Akebia Therapeutics
ClinicalTrials.gov Identifier: NCT01381094     History of Changes
Other Study ID Numbers: AKB-6548-CI-0005
Study First Received: June 23, 2011
Last Updated: October 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Akebia Therapeutics:
anemia
chronic kidney disease
CKD
chronic renal insufficiency
renal impairment
 erythropoietin
safety
efficacy
tolerability
pharmacokinetics

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
 Hematologic Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on May 21, 2013