16-Week Repeat Oral Dose Study of AKB-6548 for Anemia in Subjects With End Stage Renal Disease (ESRD) Requiring Chronic Hemodialysis
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease, Anemia |
| Therapuetic Areas: | Hematology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 79 |
| Updated: | 11/16/2018 |
| Start Date: | September 2014 |
| End Date: | August 2015 |
Phase 2 Open-Label Study to Assess the Efficacy, Safety, and Tolerability of AKB-6548 in Subjects With Anemia Secondary to End Stage Renal Disease (ESRD), Undergoing Chronic Hemodialysis.
The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and
tolerability of orally administered AKB-6548 in subjects with end stage renal disease
undergoing chronic hemodialysis.
tolerability of orally administered AKB-6548 in subjects with end stage renal disease
undergoing chronic hemodialysis.
Key Inclusion Criteria:
- 18 to 79 years inclusive
- Chronic Kidney Disease (CKD) Stage 5 on chronic hemodialysis for at least 3 months
- Anemia secondary to CKD treated with erythropoiesis stimulating agent and intravenous
iron
Key Exclusion Criteria:
- BMI >44.0 kg/m2
- Transfusion within 8 weeks prior to Screening
- ALT or total bilirubin >1.25x ULN
- Uncontrolled hypertension
- Class III or IV congestive heart failure
- Myocardial infarction, acute coronary syndrome, stroke or transient ischemic attack
within 6 months prior to Screening
We found this trial at
16
sites
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