Phase 3 N=369 Randomized Treatment

Efficacy and Safety Study to Evaluate Vadadustat for the Correction or Maintenance Treatment of Anemia in Participants With Incident Dialysis-dependent Chronic Kidney Disease (DD-CKD)

Anemia · Dialysis-Dependent Chronic Kidney Disease

Bottom Line

View on ClinicalTrials.gov: NCT02865850 ↗

Enrolled (actual)

369

Serious AEs

53.2%

Results posted

Jul 2022

Primary outcome: Primary: Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36) — 1.26; 1.58 Grams per deciliter (g/dL)

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Vadadustat (Drug); Darbepoetin alfa (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Akebia Therapeutics
Primary completion: Jan 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36)	1.26; 1.58	—
PRIMARY Median Time to First Major Adverse Cardiovascular Event (MACE)	26.21; 46.64	=0.9950
SECONDARY Change From Baseline in Hb to the Average Over the Secondary Efficacy Period (Weeks 40 to 52)	1.42; 1.50	—
SECONDARY Median Time to First MACE Plus Hospitalization for Heart Failure or Thromboembolic Event Excluding Vascular Access Thrombosis	27.14; 47.00	=0.8871
SECONDARY Median Time to First Cardiovascular MACE	18.50; 54.07	=0.5210
SECONDARY Median Time to First Cardiovascular Death	22.00; 58.14	=0.9527
SECONDARY Median Time to First All-cause Mortality	31.71; 45.36	=0.5115

Summary

A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction or maintenance treatment of anemia in participants with incident dialysis-dependent chronic kidney disease (DD-CKD).

Eligibility Criteria

Inclusion Criteria

≥18 years of age
Initiated chronic maintenance dialysis (either peritoneal or hemodialysis) for end-stage kidney disease within 16 weeks prior to Screening
Mean Screening hemoglobin between 8.0 and 7700 units/dose three times per week or >23,000 units per week
Darbepoetin alfa: >100 micrograms per week (mcg/week)
methoxy polyethylene glycol-epoetin beta: >100 micrograms (mcg) every other week or >200 mcg/month
Hypersensitivity to Vadadustat, Darbepoetin alfa or any of their excipients

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02865850). 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.