42-Day Repeat Oral Dose Study of 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; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01381094

AKB-6548-CI-0005

Details and patient eligibility

About

The purpose of this study is to evaluate the dose response (efficacy), pharmacodynamic response, pharmacokinetics, safety, and tolerability of orally administered AKB-6548 in pre-dialysis participants with anemia with repeat dosing for 42 days.

Enrollment: 93 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 (eGFR <60 mL/min), not yet on dialysis
• Hemoglobin (Hgb) ≤ 10.5 g/dL
• Transferring saturation ≥ 20%
• Ferritin ≥ 50 ng/mL

Key Exclusion Criteria:

• Body mass index >42
• 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 11 weeks prior to the Screening visit
• Participants meeting the criteria of ESA resistance within the previous 4 months
• Individual doses of intravenous iron of greater than 250 mg within the past 21 days
• Aspartate aminotransferase or alanine aminotransferase >1.8x upper limit of normal (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: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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93 participants in 5 patient groups, including a placebo group

AKB-6548 240 mg

Experimental group

Treatment:

Drug: AKB-6548

AKB-6548 370 mg

Experimental group

Treatment:

Drug: AKB-6548

AKB-6548 500 mg

Experimental group

Treatment:

Drug: AKB-6548

AKB-6548 630 mg

Experimental group

Treatment:

Drug: AKB-6548

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo