Safety and Efficacy Study for AKB-6548 in Participants With Chronic Kidney Disease and Anemia

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-21

Study Completion Date

2011-05-31

Brief Summary

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

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Detailed Description

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Conditions

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Anemia Kidney Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AKB-6548

Group Type EXPERIMENTAL

AKB-6548

Intervention Type DRUG

Different dose levels

Interventions

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AKB-6548

Different dose levels

Intervention Type DRUG

Eligibility Criteria

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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

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
* Participants 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No