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

Akebia Therapeutics10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anemia Kidney Disease

Interventions

AKB-6548DRUG

Different dose levels

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Locations (2)

Unnamed facility

Augusta, Georgia, United States

Unnamed facility

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Mean Change From Baseline in Hemoglobin (Hgb) on Day 29

Blood samples were collected to assess Hgb. Baseline Hgb was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). A positive change from baseline indicates that hemoglobin concentration increased.

Time frame: Baseline; Day 29

Secondary Outcomes

Mean Change From Baseline in Hematocrit on Day 29

Blood samples were collected to assess hematocrit. A positive change from baseline indicates hematocrit concentration increased.

Time frame: Baseline; Day 29

Mean Change From Baseline in Total Red Blood Cell (RBC) Count on Day 29

Blood samples were collected to assess RBC count. Baseline RBC count was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). A positive change from baseline indicates RBC count increased.

Time frame: Baseline; Day 29

Mean Change From Baseline in Absolute Reticulocyte Count on Day 29

Blood samples were collected to assess reticulocyte count. Baseline absolute reticulocyte count was defined as the average of the 3 reticulocyte counts obtained prior to dosing (Screening, Pre- Baseline, and Baseline). A positive change from baseline indicates absolute reticulocyte count increased.

Time frame: Baseline; Day 29

Mean Change From Baseline in Reticulocyte Hemoglobin (Hgb) Content on Day 29

Blood samples were collected to assess reticulocyte Hgb. Baseline Hgb was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). A positive change from baseline indicates reticulocyte Hgb content increased.

Time frame: Baseline; Day 29

Number of Participants With Absolute Change From Baseline in Hemoglobin (Hgb) at Day 29

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Blood samples were collected to assess Hgb. Baseline Hgb was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline).

Number of Participants With the Percentage Change From Baseline in Hemoglobin (Hgb) at Day 29

Blood samples were collected to assess Hgb. Baseline Hgb was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline).

Time frame: Day 29

Number of Participants With Percentage Change From Baseline in Hematocrit at Day 29

Blood samples were collected to assess hematocrit.

Time frame: Day 29

Number of Participants With Percentage Change From Baseline in Red Blood Cell (RBC) Count at Day 29

Blood samples were collected to assess RBC count. Baseline RBC count was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline).

Time frame: Day 29

Number of Participants With Change From Baseline in Absolute Reticulocyte Count at Day 29

Time frame: Day 29

Change From Baseline in Ferritin on Day 29

Blood samples were collected to assess ferritin. A positive change from baseline indicates ferritin content increased.

Time frame: Baseline; Day 29

Change From Baseline in Iron on Day 29

Blood samples were collected to assess iron. A positive change from baseline indicates iron content increased.

Time frame: Baseline; Day 29

Change From Baseline in Total Iron Binding Capacity on Day 29

Blood samples were collected to assess total iron binding capacity. A positive change from baseline indicates total iron binding capacity increased.

Time frame: Baseline; Day 29

Change From Baseline in Transferrin Saturation on Day 29

Blood samples were collected to assess transferrin saturation. The transferrin saturation is the ratio of the serum iron concentration and the total iron-binding capacity, expressed as a percentage. A positive change from baseline indicates transferrin saturation increased.

Time frame: Baseline; Day 29

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

An Adverse Event (AE) was defined as any untoward medical occurrence, signs, symptoms, disease, or laboratory or physiological observations occurring in a participant administered with drug, regardless of a causal relationship with that treatment or usage. This also included all suspected adverse medication reactions, reactions from medication overdose, abuse, withdrawal, sensitivity, toxicity, unrelated illnesses, including worsening a pre-existing condition, injury, or accidents. Serious Adverse Events (SAEs) was defined as any life-threatening condition; hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or death.