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Safety and Efficacy Study for 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:
NCT01235936
First received: November 5, 2010
Last updated: September 27, 2012
Last verified: September 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of repeat doses of orally administered AKB-6548 in pre-dialysis subjects with anemia.


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2a Open-Label Pilot Study to Assess the Pharmacodynamic Response, Pharmacokinetics, Safety, and Tolerability of 28-Day Repeat Oral Doses of AKB-6548 in Subjects With Anemia Secondary to Chronic Kidney Disease (CKD), Stages 3 and/or 4

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Akebia Therapeutics:

Primary Outcome Measures:
  • Hematologic response to include rate of response, actual values, change from baseline, and maximum change in hematologic parameters. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability measures will include assessments of adverse events, vital signs, ECGs, physical exam findings, and laboratory assays (hematology, chemistry, and coagulation tests). [ Time Frame: 28 days of therapy, 2 week follow-up ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic assessment will involve pre-dose plasma concentration of AKB-6548. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: October 2010
Study Completion Date: May 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AKB-6548 Drug: AKB-6548
Different dose levels

  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 Stage 3 or Stage 4
  • Hemoglobin (Hgb) < 10.5 g/dl
  • TSAT > 20% and CBC indicating normocytic red blood cell morphology

Key Exclusion Criteria:

  • BMI > 40
  • 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 10 weeks prior to the Screening visit
  • Subjects meeting the criteria of ESA resistance within the previous 4 months
  • Individual doses of intravenous iron of 250 mg or larger 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: NCT01235936

Locations
United States, Georgia
Augusta, Georgia, United States
United States, Texas
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: NCT01235936     History of Changes
Other Study ID Numbers: AKB-6548-CI-0004
Study First Received: November 5, 2010
Last Updated: September 27, 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 22, 2013