Overview

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

Status:
Completed
Trial end date:
2011-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Akebia Therapeutics
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