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
  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:


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

  Show 28 Study Locations
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 April 17, 2014