Phase 2 N=94 Treatment

16-Week Repeat Oral Dose Study of AKB-6548 for Anemia in Participants With End Stage Renal Disease (ESRD) Requiring Chronic Hemodialysis

Anemia · End Stage Renal Disease

Bottom Line

View on ClinicalTrials.gov: NCT02260193 ↗

Enrolled (actual)

Serious AEs

23.4%

Results posted

Jul 2022

Primary outcome: Primary: Change From Pre-dose Average in Hemoglobin (Hgb) Level to The Mid-study Average — 10.43; 10.55; 10.52; 0.00 Grams per deciliter (g/dL)

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: AKB-6548 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Akebia Therapeutics
Primary completion: Jul 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Pre-dose Average in Hemoglobin (Hgb) Level to The Mid-study Average	10.43; 10.55; 10.52; 0.00; -0.29; -0.36	—
PRIMARY Change From Pre-dose Average in Hgb Level to The End-of-study Average	10.43; 10.55; 10.52; -0.03; -0.07; -0.14	—
PRIMARY Change From Mid-study Average in Hgb Level to The End-of-study Average	10.41; 10.26; 10.19; -0.18; 0.16; -0.07	—
SECONDARY Change From Baseline in Hgb	10.50; 10.51; 10.50; -0.06; -0.21; -0.35	—
SECONDARY Change From Baseline in Hematocrit	31.2; 31.6; 31.4; -0.4; -1.4; -0.7	—
SECONDARY Change From Baseline in Red Blood Cell (RBC) Count	3.34; 3.49; 3.49; -0.06; -0.11; -0.16	—
SECONDARY Change From Baseline in Absolute Reticulocyte Count	0.0704; 0.0661; 0.0742; -0.0059; 0.0023; -0.0001	—
SECONDARY Change From Baseline in Percent Reticulocyte Count	2.14; 1.89; 2.19; -0.16; 0.14; 0.07	—
SECONDARY Change From Baseline in Reticulocyte Hgb Content	32.39; 32.12; 30.99; -0.13; -0.03; 1.01	—
SECONDARY Change From Baseline in Ferritin	762.88; 781.96; 807.75; -48.80; -61.21; -10.29	—
SECONDARY Change From Baseline in Hepcidin	102.59; 119.61; 105.35; -6.46; -27.80; -9.14	—
SECONDARY Change From Baseline in Total Iron-Binding Capacity (TIBC)	204.5; 196.7; 188.8; 25.7; 22.0; 18.7	—
SECONDARY Change From Baseline in Transferrin Saturation (TSAT)	34.6; 33.7; 37.5; 5.4; 2.1; 3.6	—
SECONDARY Change From Baseline in Iron	70.6; 66.6; 75.4; 20.7; 18.5; 13.3	—
SECONDARY Number of Participants Who Received Erythropoiesis-stimulating Agent (ESA) Rescue Therapy	4; 6; 2	—
SECONDARY Number of Participants Who Received Blood Transfusion Rescue Therapy	1; 1; 0	—
SECONDARY Mean Plasma Concentrations of Vadadustat	12.89; 17.27; 5.329; 13.72; 18.69; 5.287	—
SECONDARY Mean Plasma Concentrations of Vadadustat-O-Glucuronide Metabolite	16.66; 26.36; 6.295; 8.725; 13.26; 3.101	—
SECONDARY Mean Plasma Concentrations of Vadadustat-Acyl-Glucuronide Metabolite	0.0136; 0.0224; 0.0800; 0.0142; 0.0095; 0.0129	—
SECONDARY Number of Participants Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	26; 26; 26; 2; 6; 5	—
SECONDARY Number of Participants With Clinically Significant Changes From Baseline in Vital Signs	0; 0; 0	—
SECONDARY Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values	0; 0; 0	—
SECONDARY Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings	0; 0; 0	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02260193). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.