46 completed, 5 unknown, 4 not yet recruiting, 2 active not recruiting. 26 Phase 3, 16 Phase 2, 12 Phase 1, 8 Phase 4, 1 Not applicable.
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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 | Kyntra Bio | 201 | 2027-04-01 | 2026-07-23 |
| Comparison Between Darbapoeitin Alpha and Roxadustat in CKD-related Anemia Roxadustat, Darbepoetin Alfa Injection - CKD Anemia, CKD Anemia in Stable Dialysis Patients | Completed | Ain Shams University | 66 | 2026-04-15 | 2026-10-28 | |
| Roxadustat Versus Erythropoietin for Anaemia Treatment in Diabetic Nephropathy Roxadustat, Erythropoietin - Diabetic Nephropathy, Anemia | Not applicable | Completed | Hanzla Arshad | 64 | 2025-12-20 | 2026-08-26 |
| Effect of Roxadustat on Heart Failure Patients With Anaemia and Moderate-to-Severe Chronic Kidney Disease Roxadustat - Heart Failure, CKD | Not yet recruiting | Zhongda Hospital | 200 | 2025-12-01 | 2025-12-08 | |
| Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitors on Sarcopenia in Hemodialysis Patients Roxadustat, Recombinant human erythropoietin (EPO) - Sarcopenia, Anemia Associated With Chronic Kidney Disease (CKD) | Phase 4 | Not yet recruiting | Tianjin Medical University General Hospital | 60 | 2025-09-10 | 2025-09-09 |
| The Effect of Roxadustat on Renal Oxygenation in Diabetes Nephropathy Roxadustat, Darbepoietin Alfa - Diabetes Complications, Diabetes; Nephropathy (Manifestation) | Phase 2 | Not yet recruiting | Region Stockholm | 30 | 2025-06-01 | 2024-11-19 |
| Roxadustat for Bone and Neuropsychiatric Aspects in Hemodialysis Patients Roxadustat, Conventional Anemia Management - Kidney Failure,Chronic, Anemia in End Stage Renal Disease | Phase 1 / Phase 2 | Recruiting | Mansoura University | 46 | 2025-04-15 | 2025-05-11 |
| Roxadustat's Effect on Heart, Nutrition, and Inflammation in Hemodialysis Patients Roxadustat, Conventional Anemia Management - Kidney Failure, Chronic, Malnutrition-Inflammation Syndrome | Phase 1 / Phase 2 | Recruiting | Mansoura University | 46 | 2025-04-15 | 2025-05-13 |
| Effect of Perioperative Roxadustat in Elective Lumbar Interbody Fusion Surgery. Roxadustat - Perioperative Anemia | Phase 3 | Active not recruiting | Second Affiliated Hospital, Zhejiang University, School of Medicine | 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 | Astellas Pharma Global Development, Inc. | 98 | 2024-01-16 | 2026-10-13 |
| Roxadustat Combined With Luspatercept Versus Luspatercept Monotherapy in the Treatment of Refractory MDS-RS Roxadustat, Luspatercept - Myelodysplastic Syndromes | Phase 4 | Unknown | Peking Union Medical College Hospital | 62 | 2023-08-01 | 2023-08-23 |
| A Single-arm Trial of Roxadustat Combined With Retinoic Acid in the Treatment of Refractory Low-risk MDS Roxadustat in combination with retinoic acid - Myelodysplastic Syndromes | Phase 1 / Phase 2 | Withdrawn | Peking Union Medical College Hospital | 2023-08-01 | 2026-07-07 | |
| Effect of Low Doses of Hypoxia-inducible Factor- Prolyl Hydroxylase Enzyme Inhibitor Plus Iron in the Treatment of Anemia in Dialysis-dependent Chronic Kidney Disease Patients Roxadustat - Anemia in Dialysis-dependent CKD Patients | Phase 4 | Completed | Alexandria University | 72 | 2023-05-24 | 2026-06-24 |
| Study of the Safety and Efficacy of Roxadustat in the Treatment of Heart Failure With Chronic Kidney Disease and Anemia Roxadustat, Recombinant human eythropoietin and/or Iron agents - Heart Failure, Chronic Kidney Diseases | Phase 4 | Unknown | China-Japan Friendship Hospital | 300 | 2023-02-01 | 2023-01-20 |
| 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 | Kyntra Bio | 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 | Kyntra Bio | 159 | 2022-03-16 | 2023-06-06 |
| HEC53856 Phase Ib Study in Patients With Non-dialysis Renal Anemia HEC53856, Roxadustat, Placebo - Chronic Kidney Diseases, Renal Anemia | Phase 1 | Completed | Sunshine Lake Pharma Co., Ltd. | 40 | 2021-11-04 | 2025-05-15 |
| Study of Roxadustat's Effect on Anemia in Patients With Diabetic Kidney Disease Roxadustat - Diabetic Kidney Disease, Anemia | Phase 4 | Completed | Second Xiangya Hospital of Central South University | 124 | 2021-11-02 | 2026-01-26 |
| Study of Roxadustat for Reducing the Incidence of Acute Kidney Injury After Coronary Artery Bypass Grafting Roxadustat, Placebo - Coronary Artery Bypass | Phase 2 | Terminated | Peking Union Medical College Hospital | 98 | 2021-09-30 | 2025-12-09 |
| 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 | Mao Jianhua | 30 | 2021-09-01 | 2021-08-09 |
Showing 20 of 63. Sign in to see all of them.
Anemia (35) · Renal Insufficiency, Chronic (20) · Kidney Failure, Chronic (12) · Myelodysplastic Syndromes (5) · Diabetic Nephropathies (2) · Heart Failure (2) · Renal Insufficiency (2) · Acute Kidney Injury (1) · Cardiovascular Diseases (1) · Diabetes Complications (1) · Diabetes Mellitus (1) · Hepatic Insufficiency (1) · Hypoxia (1) · Kidney Diseases (1) · ST Elevation Myocardial Infarction (1)
Kyntra Bio (22) · Astellas Pharma Inc (10) · Astellas Pharma Europe B.V. (7) · AstraZeneca (3) · Peking Union Medical College Hospital (3) · Astellas Pharma Global Development, Inc. (2) · Mansoura University (2) · Ain Shams University (1) · Alexandria University (1) · China-Japan Friendship Hospital (1) · Hanzla Arshad (1) · Mao Jianhua (1) · Peking University First Hospital (1) · Region Stockholm (1) · Ruijin Hospital (1)
China (18) · United States (15) · Japan (10) · Germany (9) · Poland (8) · Russia (8) · Bulgaria (7) · Spain (7) · Romania (6) · United Kingdom (6) · Hungary (5) · Puerto Rico (5) · Slovakia (5) · Ukraine (5) · Belgium (4)
Mark Eisner (2) · Mark Houser, MD (2) · Steven Fishbane, MD (2) · Charles Bradley, PhD (1) · Jie Dong, MD (1) · Li Xuemei (1) · Lin Sun, doctor (1) · Marietta Franco (1)
PMID 36005278, PMID 36749544, PMID 38363463, PMID 38363466, PMID 34362786, PMID 26238121, PMID 26947173, PMID 31340089, PMID 31340116, PMID 32493693, PMID 33165773, PMID 33568383, PMID 33732977, PMID 34628408, PMID 34724251, PMID 35257058, PMID 35361724, PMID 35806119, PMID 36364144, PMID 36710399, PMID 37812446, PMID 38280066, PMID 38333911, PMID 39353163, PMID 39899733, PMID 42811164, PMID 42853570
2015 (1), 2018 (1)