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 |
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.
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
We found this trial at
50
sites
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