Safety and Efficacy Study for AKB-6548 in Participants With Chronic Kidney Disease and Anemia

Akebia Therapeutics

Status and phase: Completed; Phase 2

Conditions: Anemia; Kidney Disease

Treatments: Drug: AKB-6548

Study type: Interventional

Funder types: Industry

Identifiers

NCT01235936

AKB-6548-CI-0004

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, pharmacodynamics and pharmacokinetics of repeat doses of orally administered AKB-6548 in pre-dialysis participants with anemia.

Enrollment: 10 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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
• Participants 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

AKB-6548

Experimental group

Treatment:

Drug: AKB-6548