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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and tolerability of orally administered AKB-6548 in patients with Chronic Kidney Disease (pre-dialysis) with anemia with dosing for 20 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Akebia Therapeutics

Criteria

Key Inclusion Criteria:

• 18 to 82 years of age, inclusive

• Chronic Kidney Disease with a GFR category of G3a-G5 and not yet on dialysis

• eGFR ≥ 10 and ≤ 65 mL/minute/1.73 m2

• Anemia secondary to CKD with an ESA status and a Screening HGB as per protocol

• Iron replete with ferritin and TSAT levels as defined per protocol

Key Exclusion Criteria:

• BMI > 44.0 kg/m2

• Red blood cell transfusion within 11 weeks prior to the Screening visit

• Androgen therapy within the previous 21 days prior to the Screening visit

• Intravenous iron within the past 4 weeks prior to the Screening visit

• AST or ALT >1.8x ULN, alkaline phosphatase >2x ULN, or total bilirubin >1.5x ULN

• Screening ECG with QTc > 500 msec

• Uncontrolled hypertension

• Class III or IV congestive heart failure

• Myocardial infarction, acute coronary syndrome, or stroke within 6 months prior to the Screening visit