42-Day Repeat Oral Dose Study of AKB-6548 in Subjects With Chronic Kidney Disease and Anemia
Status: | Completed |
---|---|
Conditions: | Renal Impairment / Chronic Kidney Disease, Anemia |
Therapuetic Areas: | Hematology, Nephrology / Urology |
Healthy: | No |
Age Range: | 18 - 79 |
Updated: | 11/16/2018 |
Start Date: | June 2011 |
End Date: | March 2012 |
Phase 2a Randomized, Double-Blind, Placebo-Controlled, Dose Range Study to Assess the Pharmacodynamic Response, Pharmacokinetics, Safety, and Tolerability of 42-Day Repeat Oral Doses of AKB-6548 in Subjects With Anemia Secondary to Chronic Kidney Disease (CKD), Stages 3 and 4
The purpose of this study is to evaluate the dose response (efficacy), safety, and
tolerability of orally administered AKB-6548 in pre-dialysis subjects with anemia with repeat
dosing for 42 days.
tolerability of orally administered AKB-6548 in pre-dialysis subjects with anemia with repeat
dosing for 42 days.
Key Inclusion Criteria:
- 18 to 79 years of age, inclusive
- Chronic Kidney Disease (eGFR <60 mL/min), not yet on dialysis
- Hemoglobin (Hgb) ≤ 10.5 g/dL
- TSAT ≥ 20%
- Ferritin ≥ 50 ng/mL
Key Exclusion Criteria:
- BMI >42
- 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 11 weeks prior to the Screening visit
- Subjects meeting the criteria of ESA resistance within the previous 4 months
- Individual doses of intravenous iron of greater than 250 mg 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
We found this trial at
28
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