Clinical trial NCT01235936: Safety and Efficacy Study for AKB-6548 in Participants With Chronic Kidney Disease and Anemia
Official title: Phase 2a Open-Label Pilot Study to Assess the Pharmacodynamic Response, Pharmacokinetics, Safety, and Tolerability of 28-Day Repeat Oral Doses of AKB-6548 in Subjects With Anemia Secondary to Chronic Kidney Disease (CKD), Stages 3 and/or 4
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anemia
Kidney Disease
Keywords: anemia
chronic kidney disease
CKD
chronic renal insufficiency
renal impairment
erythropoietin
safety
efficacy
tolerability
pharmacokinetics
Lead sponsor: Akebia Therapeutics
Sponsor class: INDUSTRY
First posted: 2010-11-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Mean Change From Baseline in Hemoglobin (Hgb) on Day 29
timeFrame: Baseline; Day 29
Secondary outcomes:
measure: Mean Change From Baseline in Hematocrit on Day 29
timeFrame: Baseline; Day 29
measure: Mean Change From Baseline in Total Red Blood Cell (RBC) Count on Day 29
timeFrame: Baseline; Day 29
measure: Mean Change From Baseline in Absolute Reticulocyte Count on Day 29
timeFrame: Baseline; Day 29
measure: Mean Change From Baseline in Reticulocyte Hemoglobin (Hgb) Content on Day 29
timeFrame: Baseline; Day 29
measure: Number of Participants With Absolute Change From Baseline in Hemoglobin (Hgb) at Day 29
timeFrame: Day 29
measure: Number of Participants With the Percentage Change From Baseline in Hemoglobin (Hgb) at Day 29
timeFrame: Day 29
measure: Number of Participants With Percentage Change From Baseline in Hematocrit at Day 29
timeFrame: Day 29
measure: Number of Participants With Percentage Change From Baseline in Red Blood Cell (RBC) Count at Day 29
timeFrame: Day 29
measure: Number of Participants With Change From Baseline in Absolute Reticulocyte Count at Day 29
timeFrame: Day 29
measure: Change From Baseline in Ferritin on Day 29
timeFrame: Baseline; Day 29
measure: Change From Baseline in Iron on Day 29
timeFrame: Baseline; Day 29
measure: Change From Baseline in Total Iron Binding Capacity on Day 29
timeFrame: Baseline; Day 29
measure: Change From Baseline in Transferrin Saturation on Day 29
timeFrame: Baseline; Day 29
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to 2 weeks post 28 days of treatment
measure: Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values
timeFrame: Up to 2 weeks post 28 days of treatment
measure: Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values
timeFrame: Up to 2 weeks post 28 days of treatment
measure: Number of Participants With Clinically Abnormal 12-Lead Electrocardiogram (ECG) Findings
timeFrame: Up to 2 weeks post 28 days of treatment
measure: Mean Change From Baseline in PR Interval, QT Interval, QRS Interval, and QT Corrected (QTc) Interval
timeFrame: Up to 2 weeks post 28 days of treatment
measure: Mean Trough Concentrations of Vadadustat at Day 8, 15, 22 and 29
timeFrame: Pre-dose at Day 8, 15, 22 and 29
Other outcomes:
Locations:
city: Augusta
country: United States
state: Georgia
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Akebia Therapeutics Inc.
name: Chief Medical Officer
role: STUDY_DIRECTOR
References: