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Erythropoiesis-Stimulating Agent

Vadadustat for Anemia of Chronic Kidney Disease

Phase 3
Waitlist Available
Research Sponsored by Akebia Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; weeks 46-52
Awards & highlights

Study Summary

This trial will compare the efficacy and safety of vadadustat to an existing anemia treatment in hemodialysis patients.

Eligible Conditions
  • Anemia of Chronic Kidney Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; weeks 46-52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; weeks 46-52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change in hemoglobin (Hb) between Baseline (average pretreatment Hb) and the primary evaluation period (average Hb from Weeks 20 to 26, inclusive)
Number of participants with treatment-emergent non-serious adverse events and treatment-emergent serious adverse events
Secondary outcome measures
Mean change in Hb between Baseline (average pretreatment Hb) and the secondary evaluation period (average Hb from Weeks 46 to 52, inclusive)

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%
Back pain
6%
Nasopharyngitis
6%
Upper respiratory tract infection
6%
Hypotension
5%
Cough
5%
Hypoglycaemia
5%
Headache
5%
Dizziness
5%
Fluid overload
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%
Hyperglycaemia
1%
Acute left ventricular failure
1%
Escherichia urinary tract infection
1%
Chronic obstructive pulmonary disease
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

3Treatment groups
Experimental Treatment
Active Control
Group I: Vadadustat low doseExperimental Treatment1 Intervention
Participants previously receiving Mircera® received vadadustat for up to 52 weeks with an initial dose of 600 milligrams (mg).
Group II: Vadadustat high doseExperimental Treatment1 Intervention
Participants previously receiving Mircera® received vadadustat for up to 52 weeks with an initial dose of 900 mg.
Group III: Mircera®Active Control1 Intervention
Participants will continue to receive Mircera® for up to 52 weeks.
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?

Akebia TherapeuticsLead Sponsor
33 Previous Clinical Trials
9,903 Total Patients Enrolled
2 Trials studying Anemia of Chronic Kidney Disease
142 Patients Enrolled for Anemia of Chronic Kidney Disease
Chief Medical OfficerStudy DirectorAkebia Therapeutics Inc.
122 Previous Clinical Trials
21,068 Total Patients Enrolled
2 Trials studying Anemia of Chronic Kidney Disease
142 Patients Enrolled for Anemia of Chronic Kidney Disease

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do we have a comprehensive understanding of Vadadustat's effects?

"Vadadustat was first studied in 2020 at Hospital Kajang. Since the inception of the medication, there have been 101 completed trials. Right now, there are 2 clinical trials that are actively recruiting patients. Several of these trial locations are in Columbia, South carolina."

Answered by AI

In how many different areas is this experiment being conducted today?

"Currently, 59 clinical trial sites are enrolling patients for this study. While some of the centres are located in cities such as Columbia and Las Vegas, others are based in more rural areas. If you are interested in enrolling, please choose the location nearest you to avoid having to travel long distances."

Answered by AI

Are there any current vacancies for volunteers in this test?

"No, this particular study is not recruiting patients at the moment. The listing was first posted on July 21st, 2021 and was last updated on August 19th, 2022. For those still searching, there are 727 clinical trials actively recruiting patients with kidney diseases and 2 trials for Vadadustat that are presently enrolling participants."

Answered by AI

How many people are currently enrolled in this clinical trial?

"This study is not recruiting at the moment. 727 other trials for patients with kidney diseases are open and accepting participants."

Answered by AI

What are the potential risks of Vadadustat?

"Vadadustat was given a score of 3 because it is a Phase 3 trial, meaning that there is already some data to support its efficacy and multiple rounds of data to support its safety."

Answered by AI

To your knowledge, does a study like this one exist?

"Vadadustat's journey began in 2020 with a clinical sponsored by Novotech (Australia) Pty Limited. The first trial, conducted in 2020, had 391 participants. After the success of the initial Phase 3 drug trial, Vadadustat is now being studied in 8 countries across 64 cities."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects
2021. "Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04707768.
~119 spots leftby Apr 2025
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