Clinical trial NCT02260193: 16-Week Repeat Oral Dose Study of AKB-6548 for Anemia in Participants With End Stage Renal Disease (ESRD) Requiring Chronic Hemodialysis
Official title: Phase 2 Open-Label Study to Assess the Efficacy, Safety, and Tolerability of AKB-6548 in Subjects With Anemia Secondary to End Stage Renal Disease (ESRD), Undergoing Chronic Hemodialysis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anemia
End Stage Renal Disease
Keywords: anemia
end stage renal disease
chronic kidney disease
CKD
dialysis
chronic renal insufficiency
renal impairment
erythropoietin
kidney
oral anemia treatment
hemoglobin
hypoxia-inducible factor
HIF
hypoxia-inducible factor propyl-hydroxylase inhibitor
HIF-PHI
pharmacokinetics
Lead sponsor: Akebia Therapeutics
Sponsor class: INDUSTRY
First posted: 2014-10-09
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Change From Pre-dose Average in Hemoglobin (Hgb) Level to The Mid-study Average
timeFrame: Pre-dose (Screening, Second Screening, and Baseline), Week 7, and Week 8
measure: Change From Pre-dose Average in Hgb Level to The End-of-study Average
timeFrame: Pre-dose, Week 15, and Week 16
measure: Change From Mid-study Average in Hgb Level to The End-of-study Average
timeFrame: Week 7, Week 8, Week 15, and Week 16
Secondary outcomes:
measure: Change From Baseline in Hgb
timeFrame: Baseline, Week 4, Week 8, Week 12, and Week 16
measure: Change From Baseline in Hematocrit
timeFrame: Baseline, Week 4, Week 8, Week 12, and Week 16
measure: Change From Baseline in Red Blood Cell (RBC) Count
timeFrame: Baseline, Week 4, Week 8, Week 12, and Week 16
measure: Change From Baseline in Absolute Reticulocyte Count
timeFrame: Baseline, Week 4, Week 8, Week 12, and Week 16
measure: Change From Baseline in Percent Reticulocyte Count
timeFrame: Baseline, Week 4, Week 8, Week 12, and Week 16
measure: Change From Baseline in Reticulocyte Hgb Content
timeFrame: Baseline, Week 2, Week 4, Week 8, and Week 16
measure: Change From Baseline in Ferritin
timeFrame: Baseline, Week 4, Week 8, Week 12, and Week 16
measure: Change From Baseline in Hepcidin
timeFrame: Baseline, Week 8, and Week 16
measure: Change From Baseline in Total Iron-Binding Capacity (TIBC)
timeFrame: Baseline, Week 4, Week 8, Week 12, and Week 16
measure: Change From Baseline in Transferrin Saturation (TSAT)
timeFrame: Baseline, Week 4, Week 8, Week 12, and Week 16
measure: Change From Baseline in Iron
timeFrame: Baseline, Week 4, Week 8, Week 12, and Week 16
measure: Number of Participants Who Received Erythropoiesis-stimulating Agent (ESA) Rescue Therapy
timeFrame: Up to Week 16
measure: Number of Participants Who Received Blood Transfusion Rescue Therapy
timeFrame: Up to Week 16
measure: Mean Plasma Concentrations of Vadadustat
timeFrame: Pre-dialysis and post-dialysis on Week 2 and Week 16
measure: Mean Plasma Concentrations of Vadadustat-O-Glucuronide Metabolite
timeFrame: Pre-dialysis and post-dialysis on Week 2 and Week 16
measure: Mean Plasma Concentrations of Vadadustat-Acyl-Glucuronide Metabolite
timeFrame: Pre-dialysis and post-dialysis on Week 2 and Week 16
measure: Number of Participants Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Up to Week 20
measure: Number of Participants With Clinically Significant Changes From Baseline in Vital Signs
timeFrame: Up to Week 20
measure: Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values
timeFrame: Up to Week 20
measure: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings
timeFrame: Up to Week 20
Other outcomes:
measure: Mean Intravenous Iron Replacement Therapy
timeFrame: Baseline, Week 8, and Week 16
Locations:
city: El Granada
country: United States
state: California
city: Long Beach
country: United States
state: California
city: San Dimas
country: United States
state: California
city: Santa Clarita
country: United States
state: California
city: Whittier
country: United States
state: California
city: Arvada
country: United States
state: Colorado
city: Westminster
country: United States
state: Colorado
city: Naples
country: United States
state: Florida
city: North Miami Beach
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Astoria
country: United States
state: New York
city: Arlington
country: United States
state: Texas
city: Grand Prairie
country: United States
state: Texas
city: Greenville
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Mechanicsville
country: United States
state: Virginia
Study officials:
affiliation: Akebia Therapeutics Inc.
name: Chief Medical Officer
role: STUDY_DIRECTOR
References: