20 completed, 2 active not recruiting, 1 not yet recruiting, 1 terminated. 26 Phase 3, 1 Phase 2.
By phase and status
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All 26 trials
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|
A Study to Investigate the Efficacy and Safety of Roxadustat (FG-4592) for Treating Anemia in Participants With Myelodysplastic Syndromes (MDS)
Roxadustat, Placebo - Myelodysplastic Syndromes | Phase 3 | Not yet recruiting | 201 | 2027-04-01 | 2026-07-23 |
Effect of Perioperative Roxadustat in Elective Lumbar Interbody Fusion Surgery.
Roxadustat - Perioperative Anemia | Phase 3 | Active not recruiting | 158 | 2024-11-10 | 2025-01-13 |
A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease
Roxadustat - Chronic Kidney Disease, Renal Anemia | Phase 3 | Active not recruiting | 98 | 2024-01-16 | 2026-10-13 |
Investigating the Efficacy, Safety and PK of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With CKD
Roxadustat - Anemia Associated With Chronic Kidney Disease | Phase 3 | Withdrawn | | 2022-05-23 | 2022-07-05 |
A Study to Evaluate the Efficacy and Safety of Roxadustat for the Treatment of Anemia in Participants Receiving Chemotherapy Treatment for Non-Myeloid Malignancies
SEPO®, Roxadustat - Chemotherapy Induced Anemia | Phase 3 | Completed | 159 | 2022-03-16 | 2023-06-06 |
Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With CKD
Roxadustat - Anemia Associated With Chronic Kidney Disease | Phase 3 | Unknown | 30 | 2021-09-01 | 2021-08-09 |
Study of Roxadustat Conversion in Participants Receiving Stable ESA or as Initial Anemia Treatment in Hemodialysis Participants
Roxadustat - Anemia Associated With End Stage Renal Disease | Phase 3 | Completed | 283 | 2020-07-22 | 2022-07-26 |
Study of Roxadustat Conversion in Participants Receiving Stable Erythropoiesis-Stimulating Agent (ESA) or as Initial Anemia Treatment in Chronic Dialysis Participants
Roxadustat - Anemia Associated With End Stage Renal Disease (ESRD) | Phase 3 | Completed | 203 | 2020-05-26 | 2022-09-13 |
Efficacy and Safety of FG-4592 for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome (MDS)
FG-4592, Placebo - Anemia, Myelodysplastic Syndrome | Phase 2 / Phase 3 | Completed | 43 | 2018-06-06 | 2023-05-03 |
Efficacy and Safety of Roxadustat for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome With Low Red Blood Cell Transfusion Burden
Roxadustat, Placebo - Primary MDS (Very Low, Low or Intermediate IPSS-R With <5% Blasts), Anemia | Phase 3 | Terminated | 184 | 2018-01-29 | 2024-08-01 |
A Study of Intermittent Oral Dosing of ASP1517 in Non-Dialysis Chronic Kidney Disease Patients With Anemia
roxadustat, DA - Chronic Kidney Disease | Phase 3 | Completed | 334 | 2017-01-12 | 2024-10-31 |
A Study of Intermittent Oral Dosing of ASP1517 in ESA-untreated Chronic Kidney Disease Patients With Anemia
roxadustat - Chronic Kidney Disease | Phase 3 | Completed | 100 | 2017-01-11 | 2024-10-31 |
A Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia
roxadustat, Darbepoetin alfa - Hemodialysis Chronic Kidney Disease Patients With Anemia | Phase 3 | Completed | 303 | 2016-11-30 | 2024-10-30 |
A Study of Intermittent Oral Dosing of ASP1517 in Peritoneal Dialysis Chronic Kidney Disease Patients With Anemia
roxadustat - Peritoneal Dialysis Chronic Kidney Disease Patients With Anemia | Phase 3 | Completed | 56 | 2016-06-22 | 2024-10-30 |
A Study of Intermittent Oral Dosing of ASP1517 in Erythropoieses Stimulating Agent (ESA)-Naive Hemodialysis Chronic Kidney Disease Patients With Anemia
roxadustat - ESA-naive Hemodialysis Chronic Kidney Disease Patients With Anemia | Phase 3 | Completed | 75 | 2016-06-02 | 2024-10-30 |
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
roxadustat - Hemodialysis Patients With Renal Anemia | Phase 3 | Completed | 164 | 2016-05-16 | 2024-10-31 |
FG-4592 for Treatment of Anemia in Subjects With Chronic Kidney Disease
FG-4592, Epoetin Alfa - Anemia | Phase 3 | Completed | 305 | 2015-12-01 | 2017-08-24 |
FG-4592 for Treatment of Anemia in Subjects With Chronic Kidney Disease Not on Dialysis
FG-4592, Placebo - Anemia | Phase 3 | Completed | 154 | 2015-12-01 | 2017-08-24 |
Study to Evaluate the Efficacy and Safety of Roxadustat in the Treatment of Anemia in Participants With ESRD on Stable Dialysis
Epoetin Alfa, Roxadustat - CKD Anemia in Stable Dialysis Patients | Phase 3 | Completed | 741 | 2015-01-15 | 2021-10-29 |
Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis
Roxadustat, Epoetin alfa, Darbepoetin alfa - Anemia, End Stage Renal Disease (ESRD) | Phase 3 | Completed | 838 | 2014-11-21 | 2024-11-27 |
Showing 20 of 26. Sign in to see all of them.
Conditions studied
Anemia (18) · Renal Insufficiency, Chronic (12) · Kidney Failure, Chronic (5) · Myelodysplastic Syndromes (3)
Sponsors
Kyntra Bio (12) · Astellas Pharma Inc (6) · Astellas Pharma Europe B.V. (3) · AstraZeneca (2) · Astellas Pharma Global Development, Inc. (1) · Mao Jianhua (1) · Second Affiliated Hospital, Zhejiang University, School of Medicine (1)
Countries
United States (9) · Poland (8) · Russia (7) · Spain (7) · Bulgaria (6) · China (6) · Japan (6) · Romania (6) · Germany (5) · Hungary (5) · Slovakia (5) · Ukraine (5) · United Kingdom (5) · Belgium (4) · Colombia (4)
Top investigators
Mark Eisner (2) · Mark Houser, MD (2) · Steven Fishbane, MD (2) · Charles Bradley, PhD (1) · Mark Eisner, MD, MPH (1) · Meraf Eyassu (1) · Min Yan, MD, PhD (1)
Results publications
PMID 36005278, PMID 36749544, PMID 38363463, PMID 38363466, PMID 34362786, PMID 31340089, PMID 31340116, PMID 32493693, PMID 33568383, PMID 33732977, PMID 34628408, PMID 34724251, PMID 35361724, PMID 36710399, PMID 39353163