Overview
Safety and Efficacy Study for AKB-6548 in Subjects With Chronic Kidney Disease and Anemia
Status:
Completed
Completed
Trial end date:
2011-05-01
2011-05-01
Target enrollment:
0
0
Participant gender:
All
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 2Accepts Healthy Volunteers?
NoDetails
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