34 completed, 3 withdrawn, 1 active not recruiting, 1 not yet recruiting. 17 Phase 3, 13 Phase 1, 11 Phase 2, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 17 | Completed 12, Withdrawn 3, Active not recruiting 1, Recruiting 1 |
| Phase 1 | 13 | Completed 13 |
| Phase 2 | 11 | Completed 9, Recruiting 1, Terminated 1 |
| Phase 4 | 1 | Not yet recruiting 1 |
Follow vadadustat: new trials by email Literature Review of vadadustat trials Research Report on vadadustat
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 |
|---|---|---|---|---|---|---|
| Effects of Vadadustat on Anemia, Quality of Life, and Inflammation in Dialysis Patients Vadadustat - Renal Anemia | Phase 4 | Not yet recruiting | Mackay Memorial Hospital | 40 | 2026-04-15 | 2026-04-23 |
| Vadadustat for the Treatment of Nonintubated Acute Respiratory Distress Syndrome Due to Pathogen-Associated Lung Injury Vadadustat 900mg, Vadadustat 1200mg, Placebo - Nonintubated Acute Respiratory Distress Syndrome (ARDS), Pathogen-associated Lung Injury | Phase 2 / Phase 3 | Recruiting | Paul Potnuru | 1100 | 2025-10-23 | 2026-08-10 |
| To Evaluate the Efficacy of Three Times Weekly (TIW) Vadadustat Compared to Standard of Care ESA in Patients With Anemia of CKD Receiving In-Center Hemodialysis Erythropoiesis-Stimulating Agent (ESA), Vadadustat - Anemia of Chronic Kidney Disease | Phase 3 | Completed | Akebia Therapeutics | 353 | 2025-07-24 | 2026-09-04 |
| Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease vadadustat - Anemia of Chronic Kidney Disease | Phase 3 | Withdrawn | Akebia Therapeutics | 2025-01-01 | 2025-10-01 | |
| Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease Naive to Erythropoiesis-Stimulating Agents Vadadustat - Anemia of Chronic Kidney Disease | Phase 3 | Withdrawn | Akebia Therapeutics | 2025-01-01 | 2025-10-01 | |
| Vafseo Outcomes In-Center Experience Vadadustat, Erythropoiesis Stimulating Agent - Anemia of Chronic Kidney Disease | Phase 3 | Active not recruiting | USRC Kidney Research | 2200 | 2024-11-20 | 2026-03-10 |
| Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects Vadadustat, Mircera® - Anemia Associated With Chronic Kidney Disease (CKD) | Phase 3 | Completed | Akebia Therapeutics | 456 | 2021-06-18 | 2025-01-15 |
| Vadadustat for the Prevention and Treatment of Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Patients With Coronavirus Disease 2019 (COVID-19) vadadustat, placebo - Acute Respiratory Distress Syndrome, Coronavirus Infection | Phase 2 | Completed | The University of Texas Health Science Center, Houston | 448 | 2020-08-22 | 2025-03-26 |
| Study in Healthy Adult Subjects to Assess the Effect of Phosphate Binders on the Pharmacokinetics of a Single Dose of Vadadustat Vadadustat, Sevelamer carbonate, Calcium acetate - Healthy Volunteers | Phase 1 | Completed | Akebia Therapeutics | 54 | 2020-06-15 | 2020-10-08 |
| Trial Evaluating the Efficacy and Safety of Oral Vadadustat Once Daily (QD) and Three Times Weekly (TIW) for the Maintenance Treatment of Anemia in Hemodialysis Subjects Converting From Erythropoiesis-Stimulating Agents (ESAs) Vadadustat, Darbepoetin alfa - Anemia | Phase 3 | Completed | Akebia Therapeutics | 319 | 2020-05-27 | 2025-05-22 |
| Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vadadustat in Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease Vadadustat, Darbepoetin alfa, Epoetin alfa - Anemia Associated With Chronic Kidney Disease | Phase 1 | Completed | Akebia Therapeutics | 46 | 2019-05-28 | 2020-09-16 |
| Study of Vadadustat in Hemodialysis Participants With Anemia Switching From Epoetin Alfa Vadadustat, Epoetin Alfa, Vadadustat TIW - Anemia, Dialysis-dependent Chronic Kidney Disease | Phase 2 | Completed | Akebia Therapeutics | 175 | 2019-01-31 | 2022-09-29 |
| Study to Evaluate the Effect of Rabeprazole on the Pharmacokinetics of Vadadustat Vadadustat, Rabeprazole - Drug Interaction Potentiation, Pharmacokinetics | Phase 1 | Completed | Akebia Therapeutics | 20 | 2018-10-03 | 2019-03-22 |
| Effects of Iron Supplements on the Pharmacokinetics of MT-6548 MT-6548, Iron supplement A, Iron supplement B - Healthy | Phase 3 | Completed | Tanabe Pharma Corporation | 61 | 2018-08-27 | 2026-04-06 |
| A Study in Evaluating Bioequivalence of Test and Reference Vadadustat 450 MG and 150 MG Tablets and to Determine Food Effect on the 450 MG Tablet vadadustat - Healthy | Phase 1 | Completed | Akebia Therapeutics | 54 | 2018-08-03 | 2019-03-22 |
| Drug-Drug Interaction Study of Vadadustat With Digoxin, Adefovir and Furosemide Vadadustat, Furosemide, Adefovir - Drug Interaction Potentiation | Phase 1 | Completed | Akebia Therapeutics | 62 | 2018-07-20 | 2019-03-22 |
| Drug-Drug Interaction Study of Vadadustat With Cyclosporine, Probenecid and Rifampin vadadustat, Rifampin, Probenecid - Drug Interaction Potentiation | Phase 1 | Completed | Akebia Therapeutics | 40 | 2018-07-20 | 2019-03-22 |
| Drug-Drug Interaction Study of Vadadustat With Rosuvastatin, Sulfasalazine, Pravastatin, Atorvastatin and Simvastatin Vadadustat, Simvastatin, Rosuvastatin - Drug Interaction Potentiation | Phase 1 | Completed | Akebia Therapeutics | 134 | 2018-06-17 | 2019-03-22 |
| A Single Dose Study of Oral Vadadustat in Subjects With Normal and Impaired Hepatic Function Vadadustat - Hepatic Impairment | Phase 1 | Completed | Akebia Therapeutics | 24 | 2018-06-12 | 2019-03-22 |
| A Study in Evaluating Bioequivalence Between Test and Reference Formulations of Vadadustat Tablets in Healthy Adults vadadustat reference tablets, vadadustat test tablets - Healthy | Phase 1 | Completed | Akebia Therapeutics | 50 | 2018-04-12 | 2019-03-22 |
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Anemia (25) · Renal Insufficiency, Chronic (18) · Renal Insufficiency (11) · Kidney Diseases (4) · Kidney Failure, Chronic (3) · COVID-19 (1) · Coronavirus Infections (1) · Respiratory Distress Syndrome (1)
Akebia Therapeutics (32) · Tanabe Pharma Corporation (5) · Mackay Memorial Hospital (1) · Paul Potnuru (1) · The University of Texas Health Science Center, Houston (1) · USRC Kidney Research (1)
United States (27) · Canada (7) · Japan (7) · Italy (5) · Poland (5) · Argentina (4) · Brazil (4) · Mexico (4) · Russia (4) · South Korea (4) · Ukraine (4) · Australia (3) · Bulgaria (3) · France (3) · Germany (3)
Bentley J. Bobrow, MD (1) · Paul Potnuru, MD (1)
PMID 36005278, PMID 40359056, PMID 33913637, PMID 33913638, PMID 37096396, PMID 38530490, PMID 39231617, PMID 27650732, PMID 28343225, PMID 33283981, PMID 33650630, PMID 33883252, PMID 34115437, PMID 34511184, PMID 37427292, PMID 39521398, PMID 40790188
2015 (2), 2016 (2), 2019 (1)