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

Akebia Therapeutics

Status and phase: Completed; Phase 2

Conditions: Anemia; End Stage Renal Disease

Treatments: Drug: AKB-6548

Study type: Interventional

Funder types: Industry

Identifiers

NCT02260193

AKB-6548-CI-0011

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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:

• Body mass index >44.0 kilograms per meter squared (kg/m^2)
• Transfusion within 8 weeks prior to Screening
• Alanine transaminase 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 3 patient groups

AKB-6548, starting dose 1

Experimental group

Treatment:

Drug: AKB-6548

Drug: AKB-6548

Drug: AKB-6548

AKB-6548, starting dose 2

Experimental group

Treatment:

Drug: AKB-6548

Drug: AKB-6548

Drug: AKB-6548

AKB-6548, starting dose 3

Experimental group

Treatment:

Drug: AKB-6548

Drug: AKB-6548

Drug: AKB-6548