Roxadustat

Generic Name: Roxadustat

Brand Names: Evrenzo

Drug Type: Small Molecule

Chemical Formula: C_₁₉H_₁₆N_₂O_₅

CAS Number: 808118-40-3

Unique Ingredient Identifier: X3O30D9YMX

Background: Roxadustat is a first-in-class hypoxia-inducible factor prolyl hydroxylase inhibitor used to treat anemia associated with chronic kidney disease. It works by reducing the breakdown of the hypoxia-inducible factor (HIF), which is a transcription factor that stimulates red blood cell production in response to low oxygen levels. Roxadustat was first approved by...

Indication: Roxadustat is indicated for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease (CKD).

Associated Conditions: Anemia

Associated Therapies: -

Clinical Trials

Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease, on Dialysis.

Phase 3

Completed

Conditions: Anemia

Interventions: Drug: Roxadustat
Drug: Epoetin alfa

First Posted Date: 2014-06-25

Last Posted Date: 2019-12-16

Lead Sponsor: AstraZeneca

Target Recruit Count: 2133

Registration Number: NCT02174731

Locations: 🇻🇳
Research Site, Hue, Vietnam

Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease (CKD), Not on Dialysis

Phase 3

Completed

Conditions: Anemia

Interventions: Drug: Placebo
Drug: Roxadustat

First Posted Date: 2014-06-25

Last Posted Date: 2019-12-16

Lead Sponsor: AstraZeneca

Target Recruit Count: 2781

Registration Number: NCT02174627

Locations: 🇻🇳
Research Site, Hue, Vietnam

Safety and Efficacy Study of Roxadustat (FG-4592) for the Treatment of Anemia in End-Stage Renal Disease (ESRD) Newly Initiated Dialysis Participants

Phase 3

Completed

Conditions: Anemia in Incident Dialysis Patients

Interventions: Drug: Epoetin Alfa
Drug: Roxadustat

First Posted Date: 2014-02-03

Last Posted Date: 2021-10-01

Lead Sponsor: FibroGen

Target Recruit Count: 1043

Registration Number: NCT02052310

Locations: 🇧🇬
Invesigational Site, Stara Zagora, Bulgaria
🇷🇺
Investigational site, St. Petersburg, Russian Federation
🇺🇸
Meridian, Meridian, Idaho, United States

and more 5 locations

Roxadustat in the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients, Not on Dialysis, in Comparison to Darbepoetin Alfa

Phase 3

Completed

Conditions: Anemia in Chronic Kidney Disease in Non-dialysis Patients

Interventions: Drug: Roxadustat
Drug: Darbepoetin alfa

First Posted Date: 2013-12-27

Last Posted Date: 2024-11-14

Lead Sponsor: Astellas Pharma Europe B.V.

Target Recruit Count: 616

Registration Number: NCT02021318

Locations: 🇧🇬
Site BG35927, Sofia, Bulgaria
🇫🇷
Site FR33004, Avignon, France
🇩🇪
Site DE49057, Hoyerswerda, Germany

and more 122 locations

Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not Requiring Dialysis

Phase 3

Completed

Conditions: Anemia in Chronic Kidney Disease in Non-dialysis Patients

Interventions: Drug: Placebo
Drug: Roxadustat

First Posted Date: 2013-06-27

Last Posted Date: 2024-11-14

Lead Sponsor: Astellas Pharma Europe B.V.

Target Recruit Count: 594

Registration Number: NCT01887600

Locations: 🇪🇸
Site ES34011, Galdakao, Vizcaya, Spain
🇪🇸
Site ES34003, Barcelona, Spain
🇺🇦
Site UA38015, Kherson, Ukraine

and more 135 locations

A Study to Investigate the Effect of ASP1517 After Intermittent Oral Dosing in Dialysis Chronic Kidney Disease Patients With Anemia Compared With Darbepoetin as a Reference Drug

Phase 2

Completed

Conditions: Renal Anemia Associated With Chronic Renal Failure (CRF)

Interventions: Drug: roxadustat
Drug: darbepoetin alfa

First Posted Date: 2013-06-27

Last Posted Date: 2024-10-30

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 130

Registration Number: NCT01888445

A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis

Phase 3

Completed

Conditions: CKD Anemia

Interventions: Drug: Placebo
Drug: Roxadustat

First Posted Date: 2012-12-17

Last Posted Date: 2021-10-01

Lead Sponsor: FibroGen

Target Recruit Count: 922

Registration Number: NCT01750190

Locations: 🇦🇷
Investigational Product, Villa Domínico, Provincia De Buenos Aires, Argentina
🇹🇭
Investigational Site, Chiang Mai, Thailand
🇵🇭
Investigational site, Pasig, Philippines

Open-Label Extension Study for the Long-Term Efficacy and Safety of Roxadustat in Participants With Dialysis and Non-Dialysis Chronic Kidney Disease

Phase 2

Completed

Conditions: Chronic Kidney Disease
End Stage Renal Disease
Anemia

Interventions: Drug: Roxadustat

First Posted Date: 2012-06-28

Last Posted Date: 2021-10-01

Lead Sponsor: FibroGen

Target Recruit Count: 15

Registration Number: NCT01630889

Locations: 🇵🇷
CAIMED School of Medicine, Ponce, Puerto Rico
🇵🇷
Consolidated Medical Plaza, Caguas, Puerto Rico
🇺🇸
Mountain Kidney & HTN Associates, PA, Asheville, North Carolina, United States

and more 2 locations

Study of Roxadustat (FG-4592) to Correct Anemia in Newly Initiated Dialysis Participants Not on Erythropoiesis-Stimulating Agent Treatment

Phase 2

Completed

Conditions: Dialysis
Anemia

Interventions: Drug: Roxadustat
Drug: Oral Iron
Drug: IV Iron

First Posted Date: 2011-08-11

Last Posted Date: 2021-10-01

Lead Sponsor: FibroGen

Target Recruit Count: 60

Registration Number: NCT01414075

Study of Roxadustat in Non-Dialysis Chronic Kidney Disease Participants With Anemia

Phase 2

Completed

Conditions: Chronic Kidney Disease
Anemia

Interventions: Drug: Roxadustat

First Posted Date: 2010-11-19

Last Posted Date: 2022-02-10

Lead Sponsor: FibroGen

Target Recruit Count: 145

Registration Number: NCT01244763

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

© Copyright 2024. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy