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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.
Information provided by (Responsible Party):
Akebia Therapeutics Identifier:
First received: June 23, 2011
Last updated: March 29, 2016
Last verified: March 2016
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
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:

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


Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01381094

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

Responsible Party: Akebia Therapeutics Identifier: NCT01381094     History of Changes
Other Study ID Numbers: AKB-6548-CI-0005 
Study First Received: June 23, 2011
Last Updated: March 29, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Akebia Therapeutics:
chronic kidney disease
chronic renal insufficiency
renal impairment

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency processed this record on October 21, 2016