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



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease, Anemia
Therapuetic Areas:Hematology, Nephrology / Urology
Healthy:No
Age Range:18 - 79
Updated:11/16/2018
Start Date:June 2011
End Date:March 2012

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Phase 2a Randomized, Double-Blind, Placebo-Controlled, Dose Range Study to Assess the Pharmacodynamic Response, Pharmacokinetics, Safety, and Tolerability of 42-Day Repeat Oral Doses of AKB-6548 in Subjects With Anemia Secondary to Chronic Kidney Disease (CKD), Stages 3 and 4

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
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