Phase 2 N=10 Treatment

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

Anemia · Kidney Disease

Bottom Line

View on ClinicalTrials.gov: NCT01235936 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2022

Primary outcome: Primary: Mean Change From Baseline in Hemoglobin (Hgb) on Day 29 — 9.91; 0.63 Grams per decilitre (g/dL) — p=0.0020

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: Apr 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Baseline in Hemoglobin (Hgb) on Day 29	9.91; 0.63	0.0020 sig
SECONDARY Mean Change From Baseline in Hematocrit on Day 29	30.43; 1.62	=0.0156 sig
SECONDARY Mean Change From Baseline in Total Red Blood Cell (RBC) Count on Day 29	3.313; 0.167	0.0098 sig
SECONDARY Mean Change From Baseline in Absolute Reticulocyte Count on Day 29	51076.00; 18647.00	=0.0195 sig
SECONDARY Mean Change From Baseline in Reticulocyte Hemoglobin (Hgb) Content on Day 29	31.49; 0.13	=0.8262
SECONDARY Number of Participants With Absolute Change From Baseline in Hemoglobin (Hgb) at Day 29	6; 5; 3; 2	—
SECONDARY Number of Participants With the Percentage Change From Baseline in Hemoglobin (Hgb) at Day 29	5; 3; 3	—
SECONDARY Number of Participants With Percentage Change From Baseline in Hematocrit at Day 29	6; 2; 2	—
SECONDARY Number of Participants With Percentage Change From Baseline in Red Blood Cell (RBC) Count at Day 29	5; 3; 3	—
SECONDARY Number of Participants With Change From Baseline in Absolute Reticulocyte Count at Day 29	8; 7; 6	—
SECONDARY Change From Baseline in Ferritin on Day 29	324.0; -52.3	=0.0020 sig
SECONDARY Change From Baseline in Iron on Day 29	69.4; -8.2	=0.2383
SECONDARY Change From Baseline in Total Iron Binding Capacity on Day 29	266.4; 43.4	=0.0039 sig
SECONDARY Change From Baseline in Transferrin Saturation on Day 29	26.1; -6.4	=0.0039 sig
SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs)	5; 0; 0	—
SECONDARY Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values	—	—
SECONDARY Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values	—	—
SECONDARY Number of Participants With Clinically Abnormal 12-Lead Electrocardiogram (ECG) Findings	—	—
SECONDARY Mean Change From Baseline in PR Interval, QT Interval, QRS Interval, and QT Corrected (QTc) Interval	183.2; -4.4; 415.6; 1.4; 95.4; 3.4	—
SECONDARY Mean Trough Concentrations of Vadadustat at Day 8, 15, 22 and 29	3260.6; 3826.3; 3667.4; 5622.4	—

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) 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01235936). 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.