16-Week Repeat Oral Dose Study of AKB-6548 for Anemia in Participants With End Stage Renal Disease (ESRD) Requiring Chronic Hemodialysis
Summary
The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and tolerability of orally administered AKB-6548 in participants with end stage renal disease undergoing chronic hemodialysis.
Timeline
- Start
- 2014-09-10
- Primary completion
- 2015-07-22
- Completion
- 2015-07-22
Outcome
Missed primary endpoint
registry analysis (superiority test); Vadadustat 300 mg Once Daily (QD) vs Vadadustat 450 mg QD; Least Squares Mean Differences 0.29 (95% CI -0.25 to 0.82) NCT02260193 ↗
registry analysis (superiority test); Vadadustat 300 mg Once Daily (QD) vs Vadadustat 450 mg QD; Least Squares Mean Differences 0.04 (95% CI -0.54 to 0.61) NCT02260193 ↗
registry analysis (superiority test); Vadadustat 300 mg Once Daily (QD) vs Vadadustat 450 mg QD; Least squares mean difference -0.34 (95% CI -0.71 to 0.04) NCT02260193 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vadadustat | Small molecule | — | Oral |