Safety and Efficacy Study for 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: | October 2010 |
| End Date: | May 2011 |
Phase 2a Open-Label Pilot Study to Assess the Pharmacodynamic Response, Pharmacokinetics, Safety, and Tolerability of 28-Day Repeat Oral Doses of AKB-6548 in Subjects With Anemia Secondary to Chronic Kidney Disease (CKD), Stages 3 and/or 4
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.
doses of orally administered AKB-6548 in pre-dialysis subjects with anemia.
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
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