16-Week Repeat Oral Dose Study of AKB-6548 for Anemia in Subjects With End Stage Renal Disease (ESRD) Requiring Chronic Hemodialysis

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Akebia Therapeutics
• Treatments: Glycine

Criteria

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