42-Day Repeat Oral Dose Study of AKB-6548 in Subjects With Chronic Kidney Disease and Anemia
42-Day Repeat Oral Dose Study of AKB-6548 in Subjects With Chronic Kidney Disease and Anemia
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.
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