Safety and Efficacy Study for AKB-6548 in Subjects With Chronic Kidney Disease and Anemia
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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 :
Actual Primary Completion Date :
Actual Study Completion Date :
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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 :
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 ]
Pharmacokinetic assessment will involve pre-dose plasma concentration of AKB-6548. [ Time Frame: 28 days ]
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Ages Eligible for Study:
18 Years to 79 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
New York Heart Association Class III or IV congestive heart failure
Myocardial infarction, acute coronary syndrome, or stroke within 6 months prior to dosing