Akebia Therapeutics, Inc.
AKBAHealthcare|Biotechnology|US
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-0.02 (-5.69%)
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Clinical Trials (43)
| Trial | Conditions | Phase | Status | Enrollment | Design | Drug |
|---|---|---|---|---|---|---|
| NCT06520826 Vafseo Outcomes In-Center Experience | Anemia of Chronic Kidney Disease | P3 | Active | 2,200 | RCT, Open-label | Vadadustat, Erythropoiesis Stimulating Agent |
| NCT07086755 Vadadustat for the Treatment of Nonintubated Acute Respiratory Distress Syndrome Due to Pathogen-Associated Lung Injury | Nonintubated Acute Respiratory Distress Syndrome (ARDS), Pathogen-associated Lung Injury | P2P3 | Recruiting | 1,100 | RCT, Double-blind | Vadadustat 900mg, Vadadustat 1200mg, Placebo |
| NCT06419205 A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G | IgA Nephropathy, Lupus Nephritis (LN) | P2 | Recruiting | 30 | Open-label | ADX-097 |
| NCT07268638 A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS) | Focal Segmental Glomerulosclerosis | P2 | Recruiting | 60 | RCT, Double-blind | Praliciguat (Part A), Praliciguat (Part B) |
| NCT07429006 SAD and MAD Study of AKB-9090 in Healthy Adult Participants | Healthy Volunteers | P1 | Recruiting | 44 | RCT, Double-blind | AKB-9090 |
| NCT04922645 Auryxia (Ferric Citrate) Therapy for In-Center and Home Dialysis Participants | Hyperphosphatemia, Anemia, Iron Deficiency | P4 | Completed | 214 | RCT, Open-label | Ferric Citrate 1 gram Oral Tablet, Standard of care phosphate-lowering therapy |
| NCT04313153 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) | Anemia | P3 | Completed | 319 | RCT, Open-label | Vadadustat, Darbepoetin alfa |
| NCT06901505 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 | Anemia of Chronic Kidney Disease | P3 | Completed | 353 | RCT, Open-label | Erythropoiesis-Stimulating Agent (ESA), Vadadustat |
| NCT05085275 Ferric Citrate for the Prevention of Renal Failure in Adults With Advanced Chronic Kidney Disease | Anemia, Iron Deficiency, Hyperphosphatemia | P3 | Completed | 289 | RCT, Double-blind | Ferric Citrate 1 GM Oral Tablet [AURYXIA], Placebo |
| NCT02648347 Study to Evaluate Vadadustat for the Correction of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease | Anemia, Non-Dialysis-Dependent Chronic Kidney Disease | P3 | Completed | 1,751 | RCT, Open-label | Vadadustat, Darbepoetin alfa |
| NCT02680574 Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD) | Anemia, Non-Dialysis-Dependent Chronic Kidney Disease | P3 | Completed | 1,725 | RCT, Open-label | Vadadustat, Darbepoetin alfa |
| NCT02892149 Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Dialysis-dependent Chronic Kidney Disease (DD-CKD) | Anemia, Dialysis-Dependent Chronic Kidney Disease | P3 | Completed | 3,554 | RCT, Open-label | Vadadustat, Darbepoetin alfa |
| NCT05082571 Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease | Anemia of Chronic Kidney Disease | P3 | Withdrawn | — | Open-label | vadadustat |
| NCT04707768 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 | Anemia Associated With Chronic Kidney Disease (CKD) | P3 | Completed | 456 | RCT, Open-label | Vadadustat, Mircera® |
| NCT07565701 Safety and Efficacy of a Phased Transition From Epogen to Three Times Weekly Oral Vadadustat for the Treatment of Anemia in Subjects Receiving In-Center Hemodialysis | Anemia Associated With Chronic Kidney Disease | P3 | Not Yet Recruiting | 100 | Open-label | Epoetin alga (Epogen)/vadadustat |
| NCT02865850 Efficacy and Safety Study to Evaluate Vadadustat for the Correction or Maintenance Treatment of Anemia in Participants With Incident Dialysis-dependent Chronic Kidney Disease (DD-CKD) | Anemia, Dialysis-Dependent Chronic Kidney Disease | P3 | Completed | 369 | RCT, Open-label | Vadadustat, Darbepoetin alfa |
| NCT03242967 Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) | Anemia, Dialysis-Dependent Chronic Kidney Disease | P3 | Withdrawn | — | RCT, Open-label | Vadadustat, Darbepoetin alfa |
| NCT05082584 Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease Naive to Erythropoiesis-Stimulating Agents | Anemia of Chronic Kidney Disease | P3 | Withdrawn | — | Open-label | Vadadustat |
| NCT01235936 Safety and Efficacy Study for AKB-6548 in Participants With Chronic Kidney Disease and Anemia | Anemia, Kidney Disease | P2 | Completed | 10 | Open-label | AKB-6548 |
| NCT03140722 Study to Evaluate Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents | Anemia, Dialysis-Dependent Chronic Kidney Disease | P2 | Terminated | 2 | RCT, Open-label | vadadustat, epoetin alfa |
| NCT01381094 42-Day Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia | Anemia, Kidney Disease | P2 | Completed | 93 | RCT, Double-blind | AKB-6548, Placebo |
| NCT03054350 Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Dialysis-Dependent Chronic Kidney Disease (DD-CKD) | Anemia, Dialysis Dependent Chronic Kidney Disease | P2 | Completed | 60 | RCT, Double-blind | Vadadustat, Placebo |
| NCT04478071 Vadadustat for the Prevention and Treatment of Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Patients With Coronavirus Disease 2019 (COVID-19) | Acute Respiratory Distress Syndrome, Coronavirus Infection | P2 | Completed | 448 | RCT, Double-blind | vadadustat, placebo |
| NCT03254485 A Study of the Effect of IW-1973 on the Exercise Capacity of Patients With Heart Failure With Preserved Ejection Fraction (HFpEF) | Heart Failure With Preserved Ejection Fraction | P2 | Completed | 196 | RCT, Double-blind | IW-1973, Placebo Oral Tablet |
| NCT04707573 Study to Assess the Safety and Pharmacokinetics of AKB-6548 in Participants With Chronic Kidney Disease (CKD), Stages 3 and 4 | Chronic Kidney Disease | P2 | Completed | 22 | Open-label | Vadadustat |
| NCT01906489 20-Week Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia | Anemia, Chronic Kidney Disease | P2 | Completed | 210 | RCT, Double-blind | AKB-6548, Placebo |
| NCT02260193 16-Week Repeat Oral Dose Study of AKB-6548 for Anemia in Participants With End Stage Renal Disease (ESRD) Requiring Chronic Hemodialysis | Anemia, End Stage Renal Disease | P2 | Completed | 94 | Open-label | AKB-6548, AKB-6548, AKB-6548 |
| NCT03054337 Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Non-Dialysis Dependent Chronic Kidney Disease (NDD-CKD) | Anemia, Non-dialysis Dependent Chronic Kidney Disease | P2 | Completed | 51 | RCT, Double-blind | Vadadustat, Placebo |
| NCT03217591 A Study to Evaluate the Soluble Guanylate Cyclase (sGC) Stimulator IW-1973 in Diabetic Nephropathy / Diabetic Kidney Disease as Measured by Albuminuria | Type 2 Diabetes Mellitus With Diabetic Nephropathy | P2 | Completed | 156 | RCT, Double-blind | IW-1973, IW-1973, Placebo |
| NCT03799627 Study of Vadadustat in Hemodialysis Participants With Anemia Switching From Epoetin Alfa | Anemia, Dialysis-dependent Chronic Kidney Disease | P2 | Completed | 175 | RCT, Open-label | Vadadustat, Epoetin Alfa, Vadadustat TIW |
| NCT02412449 Relative Bioavailability of Two Formulations of AKB-6548 and the Food Effect of a New Tablet in Healthy Adult Subjects | Healthy | P1 | Completed | 18 | RCT, Open-label | AKB-6548 tablet, reference formulation given in the fasted state, AKB-6548 tablet, test formulation given in the fasted state., AKB-6548 tablet, test formulation given in the fed state |
| NCT03789032 Study to Evaluate the Effect of Rabeprazole on the Pharmacokinetics of Vadadustat | Drug Interaction Potentiation, Pharmacokinetics | P1 | Completed | 20 | Open-label | Vadadustat, Rabeprazole |
| NCT03657290 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 | Healthy | P1 | Completed | 54 | RCT, Open-label | vadadustat |
| NCT03801759 Drug-Drug Interaction Study of Vadadustat With Digoxin, Adefovir and Furosemide | Drug Interaction Potentiation | P1 | Completed | 62 | Open-label | Vadadustat, Furosemide, Adefovir, Digoxin |
| NCT02502500 Effect of AKB-6548 on the Pharmacokinetics of Celecoxib | Healthy Volunteers | P1 | Completed | 12 | RCT, Open-label | Celecoxib, AKB-6548 |
| NCT03801746 Drug-Drug Interaction Study of Vadadustat With Cyclosporine, Probenecid and Rifampin | Drug Interaction Potentiation | P1 | Completed | 40 | RCT, Open-label | vadadustat, Rifampin, Probenecid, Cyclosporins |
| NCT02062203 Effect of AKB-6548 on Cardiac Repolarization Intervals in Healthy Volunteers | Healthy Volunteers | P1 | Completed | 50 | RCT, Double-blind | AKB-6548 (therapeutic dose), AKB-6548 (supratherapeutic dose), Placebo, Moxifloxacin |
| NCT02327546 Effects of Ferrous Sulfate on the Pharmacokinetics of AKB-6548 | Healthy Volunteers | P1 | Completed | 10 | RCT, Open-label | AKB-6548, Ferrous Sulfate |
| NCT03992066 Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vadadustat in Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease | Anemia Associated With Chronic Kidney Disease | P1 | Completed | 46 | RCT, Open-label | Vadadustat, Darbepoetin alfa, Epoetin alfa |
| NCT04299633 Study in Healthy Adult Subjects to Assess the Effect of Phosphate Binders on the Pharmacokinetics of a Single Dose of Vadadustat | Healthy Volunteers | P1 | Completed | 54 | RCT, Open-label | Vadadustat, Sevelamer carbonate, Calcium acetate, Auryxia® |
| NCT03801733 Drug-Drug Interaction Study of Vadadustat With Rosuvastatin, Sulfasalazine, Pravastatin, Atorvastatin and Simvastatin | Drug Interaction Potentiation | P1 | Completed | 134 | RCT, Open-label | Vadadustat, Simvastatin, Rosuvastatin, Atorvastatin, Pravastatin, Sulfasalazine |
| NCT03639155 A Study in Evaluating Bioequivalence Between Test and Reference Formulations of Vadadustat Tablets in Healthy Adults | Healthy | P1 | Completed | 50 | RCT, Open-label | vadadustat reference tablets, vadadustat test tablets |
| NCT03799848 A Single Dose Study of Oral Vadadustat in Subjects With Normal and Impaired Hepatic Function | Hepatic Impairment | P1 | Completed | 24 | Open-label | Vadadustat |