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HIF-PH Inhibitor

Vadadustat for Anemia of Chronic Kidney Disease (VOICE Trial)

Phase 3
Waitlist Available
Research Sponsored by USRC Kidney Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Receiving outpatient in-center hemodialysis at least three times per week for end-stage kidney disease
Adult patients greater than or equal to 18 years of age
Must not have
Contraindication to receive vadadustat or any of its known constituents per the United States Prescribing Information (USPI) as determined by the treating clinician
Concomitant use of any hypoxia-inducible factor prolyl-hydroxylases or probenecid
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is studying the safety of vadadustat given three times a week to treat anemia in hemodialysis patients with End Stage Kidney Disease. Researchers want to collect safety data from a

Who is the study for?
This trial is for adults with anemia due to chronic kidney disease who are undergoing in-center hemodialysis. Participants must be stable on their current erythropoiesis-stimulating agent treatment. Those with uncontrolled hypertension, recent blood clots, or known hypersensitivity to vadadustat cannot join.
What is being tested?
The study compares the safety of a drug called vadadustat, given three times a week, against other drugs that stimulate red blood cell production. It's designed to see if vadadustat can be safely adopted for regular use in treating anemia in patients receiving hemodialysis.
What are the potential side effects?
Possible side effects include high blood pressure, diarrhea, nausea, vomiting and muscle spasms. Since it affects red blood cell production, there may also be risks related to changes in the number of these cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am on hemodialysis for kidney failure three times a week.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot take vadadustat or its ingredients due to health reasons.
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I am not taking any medication for anemia or gout.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2020 Phase 3 trial • 1751 Patients • NCT02648347
33%
End stage renal disease
17%
Hypertension
13%
Diarrhoea
13%
Oedema peripheral
11%
Hyperkalaemia
11%
Urinary tract infection
10%
Nausea
8%
Fall
8%
Constipation
7%
Pneumonia
7%
Hyperphosphataemia
7%
Vomiting
7%
Metabolic acidosis
6%
Upper respiratory tract infection
6%
Back pain
6%
Nasopharyngitis
6%
Hypotension
5%
Headache
5%
Hypoglycaemia
5%
Cough
5%
Fluid overload
5%
Dizziness
5%
Acute kidney injury
5%
Cardiac failure congestive
5%
Arthralgia
4%
Acute myocardial infarction
3%
Bronchitis
3%
Sepsis
3%
Death
3%
Cardiac arrest
2%
Acute respiratory failure
2%
Cellulitis
2%
Cardiac failure
2%
Chronic kidney disease
2%
Cardiac failure acute
2%
Anaemia
1%
Acute left ventricular failure
1%
Chronic obstructive pulmonary disease
1%
Hyperglycaemia
1%
Escherichia urinary tract infection
1%
Deep vein thrombosis
1%
Pulmonary oedema
1%
Gastrointestinal haemorrhage
1%
Atrial fibrillation
1%
Metabolic encephalopathy
1%
Septic shock
1%
Cardio-respiratory arrest
1%
Cerebrovascular accident
1%
Diabetic ketoacidosis
1%
Transient ischaemic attack
1%
Coronary artery disease
1%
Diabetic nephropathy
1%
Hypertensive urgency
1%
Pleural effusion
1%
Gastroenteritis
1%
Osteomyelitis
1%
Urosepsis
1%
Syncope
1%
Myocardial infarction
1%
Gangrene
1%
Pulmonary hypertension
1%
Hip fracture
1%
Transaminases increased
1%
Ischaemic stroke
1%
Uraemic encephalopathy
1%
Pneumonia aspiration
1%
Renal failure
1%
Diabetic foot
1%
Non-cardiac chest pain
1%
Influenza
1%
Hypovolaemia
1%
Cardiogenic shock
1%
Clostridium difficile colitis
1%
Staphylococcal sepsis
1%
Angina pectoris
1%
Peritonitis
1%
Azotaemia
1%
Blood loss anaemia
1%
Diabetes mellitus inadequate control
1%
Respiratory failure
1%
Nephrogenic anaemia
1%
Asthenia
1%
Acute pulmonary oedema
1%
Device related infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vadadustat
Darbepoetin Alfa

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: VadadustatExperimental Treatment1 Intervention
Vadadustat, 300 mg tablets, administered orally three times per week
Group II: Erythropoiesis-stimulating agent (ESA) - Standard of Care (SOC)Active Control1 Intervention
Epoetin alfa (EPOGEN), Methoxy polyethylene glycol-epoetin beta (Mircera), or Darbepoetin alfa (Aranesp) administered as per standard of care
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vadadustat
2016
Completed Phase 3
~8830

Find a Location

Who is running the clinical trial?

USRC Kidney ResearchLead Sponsor
3 Previous Clinical Trials
664 Total Patients Enrolled
Akebia TherapeuticsIndustry Sponsor
34 Previous Clinical Trials
10,248 Total Patients Enrolled
2 Trials studying Anemia of Chronic Kidney Disease
142 Patients Enrolled for Anemia of Chronic Kidney Disease
~1467 spots leftby Jun 2026
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