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HIF-PH Inhibitor

Roxadustat for Anemia of Chronic Kidney Disease

Phase 3
Waitlist Available
Research Sponsored by FibroGen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline without rescue therapy
Awards & highlights

Study Summary

This study is evaluating whether a drug may help improve the health of children with kidney disease.

Eligible Conditions
  • Anemia of Chronic Kidney Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~averaged over weeks 16-24
This trial's timeline: 3 weeks for screening, Varies for treatment, and averaged over weeks 16-24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients with mean Hb ≥ 11.0 g/dL
Secondary outcome measures
Mean change in Hb
Time to first Hb response (this only applies to NDD patients)

Side effects data

From 2019 Phase 3 trial • 616 Patients • NCT02021318
36%
End stage renal disease
33%
Hypertension
13%
Hyperkalaemia
12%
Oedema peripheral
10%
Diarrhoea
10%
Glomerular filtration rate decreased
9%
Viral upper respiratory tract infection
8%
Urinary tract infection
8%
Nausea
8%
Iron deficiency
6%
Bronchitis
6%
Vomiting
5%
Muscle spasms
5%
Back pain
5%
Pneumonia
5%
Constipation
5%
Hyperphosphataemia
5%
Arthralgia
4%
Headache
4%
Dizziness
4%
Atrial fibrillation
4%
Dyspnoea
4%
Pruritus
3%
Sepsis
3%
Acute myocardial infarction
3%
Insomnia
3%
Cardiac failure
3%
Cardiac failure congestive
2%
Dehydration
2%
Angina pectoris
2%
Cardiac failure acute
2%
Acute kidney injury
2%
Hypertensive crisis
2%
Anaemia
2%
Pyelonephritis acute
2%
Arteriovenous fistula thrombosis
1%
Death
1%
Influenza
1%
Subdural haematoma
1%
Pulmonary embolism
1%
Cholecystitis acute
1%
General physical health deterioration
1%
Clostridium difficile colitis
1%
Azotaemia
1%
Cardiac arrest
1%
Osteomyelitis
1%
Device related infection
1%
Peritonitis
1%
Blood potassium increased
1%
Coronary artery disease
1%
Acute coronary syndrome
1%
Escherichia pyelonephritis
1%
Acute prerenal failure
1%
Renal colic
1%
Chronic obstructive pulmonary disease
1%
Pleural effusion
1%
Pulmonary hypertension
1%
Pulmonary oedema
1%
Hyponatraemia
1%
Metabolic acidosis
1%
Asthenia
1%
Cellulitis
1%
Escherichia urinary tract infection
1%
Gastroenteritis
1%
Cerebrovascular accident
1%
Urosepsis
1%
Fall
1%
Ischaemic stroke
1%
Syncope
1%
Transient ischaemic attack
1%
Uraemic encephalopathy
1%
Delirium
1%
Hypotension
1%
Peripheral arterial occlusive disease
1%
Respiratory failure
1%
Peritoneal dialysis complication
1%
Prostate cancer
1%
Peripheral ischaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Darbepoetin Alfa
Roxadustat

Trial Design

1Treatment groups
Experimental Treatment
Group I: RoxadustatExperimental Treatment1 Intervention
Starting doses of 20, 50, 70 or 100 mg based on weight.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Roxadustat
2012
Completed Phase 4
~11230

Find a Location

Who is running the clinical trial?

AstraZenecaIndustry Sponsor
4,262 Previous Clinical Trials
288,595,242 Total Patients Enrolled
1 Trials studying Anemia of Chronic Kidney Disease
25 Patients Enrolled for Anemia of Chronic Kidney Disease
FibroGenLead Sponsor
57 Previous Clinical Trials
15,304 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Investigating the Efficacy, Safety and PK of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With CKD
2022. "Investigating the Efficacy, Safety and PK of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With CKD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04621331.
~0 spots leftby Apr 2025
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