Roxadustat
- Generic Name
- Roxadustat
- Brand Names
- Evrenzo
- Drug Type
- Small Molecule
- Chemical Formula
- C19H16N2O5
- 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
- -
Efficacy and Safety of Roxadustat for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome With Low Red Blood Cell Transfusion Burden
- Conditions
- Interventions
- First Posted Date
- 2017-08-28
- Last Posted Date
- 2024-08-01
- Lead Sponsor
- FibroGen
- Target Recruit Count
- 184
- Registration Number
- NCT03263091
- Locations
- 🇺🇸
Investgational site, Atlanta, Georgia, United States
🇺🇸Investiational Site, Weston, Florida, United States
🇮🇱Investigational site, Tel HaShomer, Israel
A Study of Intermittent Oral Dosing of ASP1517 in Non-Dialysis Chronic Kidney Disease Patients With Anemia
- First Posted Date
- 2016-12-12
- Last Posted Date
- 2024-10-31
- Lead Sponsor
- Astellas Pharma Inc
- Target Recruit Count
- 334
- Registration Number
- NCT02988973
- Locations
- 🇯🇵
Site JP00010, Toyama, Japan
🇯🇵Site JP00057, Kitakyusyu, Fukuoka, Japan
🇯🇵Site JP00009, Kasugai, Aichi, Japan
A Phase 1 Study of Roxadustat in Subjects With Different Degrees of Renal Function
- First Posted Date
- 2016-11-16
- Last Posted Date
- 2020-02-12
- Lead Sponsor
- Astellas Pharma Europe B.V.
- Target Recruit Count
- 34
- Registration Number
- NCT02965040
- Locations
- 🇩🇪
Site DE49001, Munchen, Germany
🇬🇧Site GB44001, Liverpool, United Kingdom
A Study of Intermittent Oral Dosing of ASP1517 in ESA-untreated Chronic Kidney Disease Patients With Anemia
- First Posted Date
- 2016-11-16
- Last Posted Date
- 2024-10-31
- Lead Sponsor
- Astellas Pharma Inc
- Target Recruit Count
- 100
- Registration Number
- NCT02964936
- Locations
- 🇯🇵
Site JP00029, Iwate, Japan
🇯🇵Site JP00032, Oita, Japan
🇯🇵Site JP00019, Saitama, Japan
A Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia
- Conditions
- Interventions
- First Posted Date
- 2016-11-02
- Last Posted Date
- 2024-10-30
- Lead Sponsor
- Astellas Pharma Inc
- Target Recruit Count
- 303
- Registration Number
- NCT02952092
- Locations
- 🇯🇵
Site JP00033, Aichi, Japan
🇯🇵Site JP00004, Ehime, Japan
🇯🇵Site JP00041, Ibaraki, Japan
A Study of Intermittent Oral Dosing of ASP1517 in Erythropoieses Stimulating Agent (ESA)-Naive Hemodialysis Chronic Kidney Disease Patients With Anemia
- Conditions
- Interventions
- First Posted Date
- 2016-05-23
- Last Posted Date
- 2024-10-30
- Lead Sponsor
- Astellas Pharma Inc
- Target Recruit Count
- 75
- Registration Number
- NCT02780141
- Locations
- 🇯🇵
Site JP00003, Aichi, Japan
🇯🇵Site JP00005, Aichi, Japan
🇯🇵Site JP00002, Niigata, Japan
A Study of Intermittent Oral Dosing of ASP1517 in Peritoneal Dialysis Chronic Kidney Disease Patients With Anemia
- Conditions
- Interventions
- First Posted Date
- 2016-05-23
- Last Posted Date
- 2024-10-30
- Lead Sponsor
- Astellas Pharma Inc
- Target Recruit Count
- 56
- Registration Number
- NCT02780726
- Locations
- 🇯🇵
Site JP00005, Fukuoka, Japan
🇯🇵Site JP00004, Aichi, Japan
🇯🇵Site JP00003, Nagano, Japan
A Long Term Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia Converted From Erythropoieses Stimulating Agent (ESA) Treatment
- First Posted Date
- 2016-05-20
- Last Posted Date
- 2024-10-31
- Lead Sponsor
- Astellas Pharma Inc
- Target Recruit Count
- 164
- Registration Number
- NCT02779764
- Locations
- 🇯🇵
Site JP00001, Yamaguchi, Japan
🇯🇵Site JP00004, Gunma, Japan
🇯🇵Site JP00021, Hokkaido, Japan
Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis
- Conditions
- Interventions
- First Posted Date
- 2014-10-30
- Last Posted Date
- 2024-11-27
- Lead Sponsor
- Astellas Pharma Europe B.V.
- Target Recruit Count
- 838
- Registration Number
- NCT02278341
- Locations
- 🇵🇱
Site PL48002, Katowice, Poland
🇭🇷Site HR38509, Zagreb, Grad Zagreb, Croatia
🇭🇷Site HR38505, Karlovac, Croatia
Study to Evaluate the Efficacy and Safety of Roxadustat in the Treatment of Anemia in Participants With ESRD on Stable Dialysis
- Conditions
- Interventions
- First Posted Date
- 2014-10-24
- Last Posted Date
- 2021-10-29
- Lead Sponsor
- FibroGen
- Target Recruit Count
- 741
- Registration Number
- NCT02273726
- Locations
- 🇵🇷
Research Center, San Juan, Puerto Rico
Drug Development Updates
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