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

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• 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 (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