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



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease, Anemia
Therapuetic Areas:Hematology, Nephrology / Urology
Healthy:No
Age Range:18 - 82
Updated:11/16/2018
Start Date:July 2013
End Date:October 2014

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Phase 2b Randomized, Double-Blind, Placebo-Controlled Study to Assess the Pharmacodynamic Response, Safety, and Tolerability to 20 Weeks of Oral Dosing of AKB-6548 in Subjects With Anemia Secondary to Chronic Kidney Disease (CKD), GFR Categories G3a-G5 (Stages 3, 4, AND 5) (Pre-Dialysis)

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.


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
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