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