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Safety and Efficacy Study for 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: NCT01235936
Recruitment Status : Completed
First Posted : November 8, 2010
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 safety, efficacy, and pharmacokinetics of repeat doses of orally administered AKB-6548 in pre-dialysis subjects with anemia.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AKB-6548 Drug: AKB-6548
Different dose levels




Primary Outcome Measures :
  1. Hematologic response to include rate of response, actual values, change from baseline, and maximum change in hematologic parameters. [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. 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 ]
  2. Pharmacokinetic assessment will involve pre-dose plasma concentration of AKB-6548. [ Time Frame: 28 days ]


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 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

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): NCT01235936


Locations
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United States, Georgia
Augusta, Georgia, United States
United States, Texas
San Antonio, Texas, United States
Sponsors and Collaborators
Akebia Therapeutics
Investigators
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Study Director: Akebia Therapeutics, MD Sponsor GmbH

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Responsible Party: Akebia Therapeutics
ClinicalTrials.gov Identifier: NCT01235936     History of Changes
Other Study ID Numbers: AKB-6548-CI-0004
First Posted: November 8, 2010    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
Glycine
Glycine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs