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Clinical trials
catalyst calendar across sponsors →Studies where AKBA is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
37 interventional · 17 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3GNCT06419205Number of participants reporting treatment emergent adverse events (TEAEs)Open-label · Treatment | Phase 2 | Recruiting | Drug: ADX-097 | IgA Nephropathy, Lupus Nephritis (LN), C3 (Complement Component 3) Glomerulopathy | 30 | Feb 2028 | ≤ 559 d | 2026-08-04 |
| A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS)NCT07268638Change from Baseline in urine protein-to-creatinine ratio (UPCR)Randomized · Triple-masked · Treatment | Phase 2 | Recruiting | Drug: Praliciguat · Other: Placebo | Focal Segmental Glomerulosclerosis | 60 | Jun 2027 | ≤ 315 d | 2026-08-13 |
| SAD and MAD Study of AKB-9090 in Healthy Adult ParticipantsNCT07429006Number of participants who will report serious Treatment emergent adverse events (TEAEs) and TEAEsRandomized · Double-masked · Treatment | Phase 1 | Recruiting | Drug: AKB-9090 · Other: Placebo | Healthy Volunteers | 70 | Oct 2026 | ≤ 73 d | 2026-04-13 |
| 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 HemodialysisNCT06901505Change in hemoglobin (Hb)Randomized · Open-label · Treatment | Phase 3 | Active, not recruiting | Drug: Erythropoiesis-Stimulating Agent (ESA), Vadadustat | Anemia of Chronic Kidney Disease | 353 | Aug 2026 | ≤ 12 d | 2026-02-23 |
| Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney DiseaseNCT05082571Mean Change in Hemoglobin (Hb) Values Between Baseline and the Primary Evaluation Period (Average Hb From Weeks 21 to 28)Open-label · Treatment | Phase 3 | Withdrawnsponsor's stated reason: Sponsor decision | Drug: vadadustat | Anemia of Chronic Kidney Disease | 0 | Jul 2026 | — | 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 AgentsNCT05082584Mean Change in Hemoglobin (Hb) Values Between Baseline and the Primary Evaluation Period (Average Hb From Weeks 21 to 28)Open-label · Treatment | Phase 3 | Withdrawnsponsor's stated reason: Sponsor decision | Drug: Vadadustat | Anemia of Chronic Kidney Disease | 0 | Jul 2026 | — | 2025-10-01 |
| 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 SubjectsNCT04707768results2025-01-15Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Evaluation Period (PEP) (Weeks 20 to 26)Randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Vadadustat, Mircera® | Anemia Associated With Chronic Kidney Disease (CKD) | 456 | 2023-01-06actual | — | 2025-01-15 |
| 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)NCT04313153results2025-05-22Change From Baseline in Hb to the Average Over the Primary Evaluation Period (PEP) (Weeks 20 to 26)Randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Vadadustat, Darbepoetin alfa | Anemia | 319 | 2021-11-26actual | — | 2025-05-22 |
| Study in Healthy Adult Subjects to Assess the Effect of Phosphate Binders on the Pharmacokinetics of a Single Dose of VadadustatNCT04299633Vadadustat area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast)Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Vadadustat, Sevelamer carbonate, Calcium acetate, Auryxia® | Healthy Volunteers | 54 | 2020-08-02actual | — | 2020-10-08 |
| Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)NCT02680574results2022-06-27Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36)Randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Vadadustat, Darbepoetin alfa | Anemia, Non-Dialysis-Dependent Chronic Kidney Disease | 1,725 | 2020-06-18actual | — | 2022-06-27 |
| Study of Vadadustat in Hemodialysis Participants With Anemia Switching From Epoetin AlfaNCT03799627results2022-09-29Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP)Randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Vadadustat, Epoetin Alfa, Vadadustat TIW | Anemia, Dialysis-dependent Chronic Kidney Disease | 175 | 2020-06-05actual | — | 2022-09-29 |
| Study to Evaluate Vadadustat for the Correction of Anemia in Participants With Non-dialysis-dependent Chronic Kidney DiseaseNCT02648347results2022-06-27Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36)Randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Vadadustat, Darbepoetin alfa | Anemia, Non-Dialysis-Dependent Chronic Kidney Disease | 1,751 | 2020-06-04actual | — | 2022-06-27 |
| Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vadadustat in Hemodialysis Subjects With Anemia Associated With Chronic Kidney DiseaseNCT03992066Mean area under concentration-time curve from time 0 to the last quantifiable concentration (AUClast)Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Vadadustat, Darbepoetin alfa, Epoetin alfa | Anemia Associated With Chronic Kidney Disease | 46 | 2020-05-05actual | — | 2020-09-16 |
| 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)NCT02865850results2022-07-18Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36)Randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Vadadustat, Darbepoetin alfa | Anemia, Dialysis-Dependent Chronic Kidney Disease | 369 | 2020-01-31actual | — | 2022-07-18 |
| Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Dialysis-dependent Chronic Kidney Disease (DD-CKD)NCT02892149results2022-06-28Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36)Randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Vadadustat, Darbepoetin alfa | Anemia, Dialysis-Dependent Chronic Kidney Disease | 3,554 | 2020-01-16actual | — | 2022-06-28 |
| A Study to Evaluate the Soluble Guanylate Cyclase (sGC) Stimulator IW-1973 in Diabetic Nephropathy / Diabetic Kidney Disease as Measured by AlbuminuriaNCT03217591results2022-09-15Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) and Study Drug-Related TEAEsRandomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: IW-1973, IW-1973, Placebo | Type 2 Diabetes Mellitus With Diabetic Nephropathy | 156 | 2019-08-20actual | — | 2022-09-15 |
| A Study of the Effect of IW-1973 on the Exercise Capacity of Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)NCT03254485results2022-09-15Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Study Drug-related TEAEsRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: IW-1973, Placebo Oral Tablet | Heart Failure With Preserved Ejection Fraction | 196 | 2019-08-19actual | — | 2022-09-15 |
| Drug-Drug Interaction Study of Vadadustat With Rosuvastatin, Sulfasalazine, Pravastatin, Atorvastatin and SimvastatinNCT03801733Area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast) of rosuvastatin, sulfasalazine, pravastatin and simvastatinRandomized · Open-label · Basic science | Phase 1 | Completed | Drug: Vadadustat, Simvastatin, Rosuvastatin, Atorvastatin, Pravastatin, Sulfasalazine | Drug Interaction Potentiation | 134 | 2018-11-24actual | — | 2019-03-22 |
| Study to Evaluate the Effect of Rabeprazole on the Pharmacokinetics of VadadustatNCT03789032Area under plasma concentration-time curve from 0 to last quantifiable concentration (AUClast) for vadadustatOpen-label · Treatment | Phase 1 | Completed | Drug: Vadadustat, Rabeprazole | Drug Interaction Potentiation, Pharmacokinetics | 20 | 2018-11-09actual | — | 2019-03-22 |
| A Single Dose Study of Oral Vadadustat in Subjects With Normal and Impaired Hepatic FunctionNCT03799848Area under the concentration-time curve from dosing to last measurable concentration (AUClast)Open-label · Basic science | Phase 1 | Completed | Drug: Vadadustat | Hepatic Impairment | 24 | 2018-10-18actual | — | 2019-03-22 |
| 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 TabletNCT03657290Bioequivalence - Area under plasma concentration-time curve from 0 to last quantifiable concentration (AUClast)Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: vadadustat | Healthy | 54 | 2018-10-16actual | — | 2019-03-22 |
| Drug-Drug Interaction Study of Vadadustat With Digoxin, Adefovir and FurosemideNCT03801759Area under plasma concentration-time curve from 0 to last quantifiable concentration (AUClast) for digoxin, adefovir and furosemideNon-randomized · Open-label · Basic science | Phase 1 | Completed | Drug: Vadadustat, Furosemide, Adefovir, Digoxin | Drug Interaction Potentiation | 62 | 2018-09-30actual | — | 2019-03-22 |
| Drug-Drug Interaction Study of Vadadustat With Cyclosporine, Probenecid and RifampinNCT03801746Area under plasma concentration-time curve from 0 to last quantifiable concentration (AUClast) of vadadustatRandomized · Open-label · Basic science | Phase 1 | Completed | Drug: vadadustat, Rifampin, Probenecid, Cyclosporins | Drug Interaction Potentiation | 40 | 2018-08-15actual | — | 2019-03-22 |
| A Study in Evaluating Bioequivalence Between Test and Reference Formulations of Vadadustat Tablets in Healthy AdultsNCT03639155Area under plasma concentration-time curve from 0 to last quantifiable concentration (AUClast)Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: vadadustat reference tablets, vadadustat test tablets | Healthy | 50 | 2018-05-23actual | — | 2019-03-22 |
| Study to Evaluate Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating AgentsNCT03140722results2021-02-21Change From Baseline in Hemoglobin (Hb) Over Time During the Treatment PeriodRandomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Revised study design. | Drug: vadadustat, epoetin alfa | Anemia, Dialysis-Dependent Chronic Kidney Disease | 2 | 2018-03-21actual | — | 2021-02-21 |
| Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD)NCT03242967Mean change in Hb between baseline and the primary evaluation periodRandomized · Open-label · Treatment | Phase 3 | Withdrawnsponsor's stated reason: Revised study design. | Drug: Vadadustat, Darbepoetin alfa | Anemia, Dialysis-Dependent Chronic Kidney Disease | 0 | 2018-02-12actual | — | 2018-11-05 |
| Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Dialysis-Dependent Chronic Kidney Disease (DD-CKD)NCT03054350results2021-04-08Mean Change in Hemoglobin (Hb) Levels From Pre-treatment to the End of the Primary Efficacy PeriodRandomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Vadadustat, Placebo | Anemia, Dialysis Dependent Chronic Kidney Disease | 60 | 2017-10-24actual | — | 2021-04-08 |
| Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Non-Dialysis Dependent Chronic Kidney Disease (NDD-CKD)NCT03054337results2021-04-08Mean Change in Hemoglobin (Hb) Levels From Pre-treatment to the End of the Primary Efficacy PeriodRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Vadadustat, Placebo | Anemia, Non-dialysis Dependent Chronic Kidney Disease | 51 | 2017-07-04actual | — | 2021-04-08 |
| Effect of AKB-6548 on the Pharmacokinetics of CelecoxibNCT02502500PK parameters (Cmax)Randomized · Open-label · Other | Phase 1 | Completed | Drug: Celecoxib, AKB-6548 | Healthy Volunteers | 12 | Jul 2015actual | — | 2018-11-14 |
| 16-Week Repeat Oral Dose Study of AKB-6548 for Anemia in Participants With End Stage Renal Disease (ESRD) Requiring Chronic HemodialysisNCT02260193results2022-07-01Change From Pre-dose Average in Hemoglobin (Hgb) Level to The Mid-study AverageNon-randomized · Open-label · Treatment | Phase 2 | Completed | Drug: AKB-6548, AKB-6548, AKB-6548 | Anemia, End Stage Renal Disease | 94 | 2015-07-22actual | — | 2022-07-01 |
| Relative Bioavailability of Two Formulations of AKB-6548 and the Food Effect of a New Tablet in Healthy Adult SubjectsNCT02412449Bioavailability endpoints: Area under the plasma concentration-time curve from 0 to last quantifiable concentration (AUC 0-t) of AKB-6548Randomized · Open-label · Other | Phase 1 | Completed | Drug: 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 | Healthy | 18 | Apr 2015actual | — | 2018-11-14 |
| Effects of Ferrous Sulfate on the Pharmacokinetics of AKB-6548NCT02327546PK parameters of AKB-6548: Maximum plasma concentration (Cmax)Randomized · Open-label · Other | Phase 1 | Completed | Drug: AKB-6548, Ferrous Sulfate | Healthy Volunteers | 10 | Dec 2014actual | — | 2018-11-14 |
| 20-Week Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and AnemiaNCT01906489results2022-07-01Percentage of Participants Achieving a Successful Hemoglobin ResponseRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: AKB-6548, Placebo | Anemia, Chronic Kidney Disease | 210 | 2014-09-03actual | — | 2022-07-21 |
| Effect of AKB-6548 on Cardiac Repolarization Intervals in Healthy VolunteersNCT02062203Placebo-corrected change-from-baseline QTcF (ΔΔQTcF) following AKB-6548 administration.Randomized · Quadruple-masked · Other | Phase 1 | Completed | Drug: AKB-6548 (therapeutic dose), AKB-6548 (supratherapeutic dose), Placebo, Moxifloxacin | Healthy Volunteers | 50 | Apr 2014actual | — | 2018-11-14 |
| 42-Day Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and AnemiaNCT01381094results2022-07-01Absolute Change From Baseline in Hemoglobin (Hgb) to End of Treatment (Week 6)Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: AKB-6548, Placebo | Anemia, Kidney Disease | 93 | 2012-02-16actual | — | 2022-07-01 |
| Safety and Efficacy Study for AKB-6548 in Participants With Chronic Kidney Disease and AnemiaNCT01235936results2022-07-01Mean Change From Baseline in Hemoglobin (Hgb) on Day 29Open-label · Treatment | Phase 2 | Completed | Drug: AKB-6548 | Anemia, Kidney Disease | 10 | 2011-04-13actual | — | 2022-07-01 |
| Study to Assess the Safety and Pharmacokinetics of AKB-6548 in Participants With Chronic Kidney Disease (CKD), Stages 3 and 4NCT04707573results2022-05-17Number of Participants With Treatment-emergent Adverse Events (TEAEs)Non-randomized · Open-label · Treatment | Phase 2 | Completed | Drug: Vadadustat | Chronic Kidney Disease | 22 | 2010-09-24actual | — | 2022-06-28 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19