24 completed, 2 active not recruiting, 1 not yet recruiting, 1 terminated. 14 Phase 3, 9 Phase 2, 6 Phase 1, 1 Phase 4.
By phase and status
Follow FG-4592: new trials by email Literature Review of FG-4592 trials Research Report on FG-4592
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Roxadustat - Anemia Associated With Chronic Kidney Disease | Phase 3 | Withdrawn | | 2022-05-23 | 2022-07-05 |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 |
Evaluation of Efficacy and Safety of Roxadustat for the Treatment of Chemotherapy Induced Anemia
Roxadustat - Chemotherapy Induced Anemia | Phase 2 | Completed | 92 | 2019-08-20 | 2022-06-03 |
Evaluate the Efficacy and Safety of Multiple Roxadustat Dosing Regimens for the Treatment of Anemia in Dialysis Participants With Chronic Kidney Disease
Roxadustat - CKD Anemia in Dialysis Participants | Phase 4 | Completed | 318 | 2019-06-11 | 2022-05-06 |
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 Phase 1 Study of Roxadustat in Subjects With Different Degrees of Renal Function
Roxadustat - Normal Renal Function, Impaired Renal Function | Phase 1 | Completed | 34 | 2016-12-12 | 2020-02-12 |
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 |
Safety and Efficacy Study of Roxadustat (FG-4592) for the Treatment of Anemia in End-Stage Renal Disease (ESRD) Newly Initiated Dialysis Participants
Roxadustat, Epoetin Alfa - Anemia in Incident Dialysis Patients | Phase 3 | Completed | 1043 | 2014-02-11 | 2021-10-01 |
Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not Requiring Dialysis
Roxadustat, Placebo - Anemia in Chronic Kidney Disease in Non-dialysis Patients | Phase 3 | Completed | 594 | 2013-09-03 | 2024-11-14 |
A Study to Investigate the Exposure and Safety and Tolerability of a Single Dose of FG-4592 in Subjects With Moderately Diminished Liver Function Compared to Those With Normal Liver Function
FG-4592 - PK of FG-4592, Hepatic Insufficiency | Phase 1 | Completed | 16 | 2013-09-01 | 2014-06-11 |
A Study to Evaluate the Dose-proportionality and Effects of FG-4592 in Healthy Young and Elderly Male and Female Subjects
FG-4592, Placebo - PK for FG-4592, Healthy Subjects | Phase 1 | Completed | 48 | 2013-09-01 | 2014-06-12 |
A Study to Evaluate the Effects of Multiple Doses of FG-4592 on the Exposure, Safety and Tolerability and Effect of Warfarin in Healthy Subjects
Warfarin, FG-4592 - Pharmacokinetics of FG-4592, Healthy Subjects | Phase 1 | Completed | 22 | 2013-09-01 | 2014-09-30 |
A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis
Roxadustat, Placebo - CKD Anemia | Phase 3 | Completed | 922 | 2012-11-05 | 2021-10-01 |
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Conditions studied
Anemia (22) · Renal Insufficiency, Chronic (13) · Kidney Failure, Chronic (9) · Myelodysplastic Syndromes (3) · Hepatic Insufficiency (1) · Renal Insufficiency (1)
Sponsors
Kyntra Bio (20) · Astellas Pharma Europe B.V. (6) · Astellas Pharma Global Development, Inc. (1) · Astellas Pharma Inc (1) · Second Affiliated Hospital, Zhejiang University, School of Medicine (1)
Countries
United States (11) · China (8) · Germany (6) · Poland (5) · Russia (5) · United Kingdom (5) · Belgium (4) · Bulgaria (4) · Italy (4) · Puerto Rico (4) · Romania (4) · Spain (4) · Colombia (3) · South Korea (3) · Turkey (Türkiye) (3)
Top investigators
Charles Bradley, PhD (1) · Marietta Franco (1) · Mark Eisner, MD, MPH (1) · Meraf Eyassu (1) · Min Yan, MD, PhD (1) · Peony Yu (1)
Results publications
PMID 36005278, PMID 38363466, PMID 34362786, PMID 36749544, PMID 26238121, PMID 26947173, PMID 31340089, PMID 31340116, PMID 33165773, PMID 33732977, PMID 34724251, PMID 36710399, PMID 39353163
NIH funding
2015 (1)