Numerous clinical trials spanning Phase 1 through Phase 4 evaluate the therapeutic efficacy, safety, and pharmacokinetics of vadadustat. Sponsored by pharmaceutical companies such as Akebia Therapeutics alongside academic institutions like The University of Texas Health Science Center, Houston, these studies primarily focus on anemia in non-dialysis and dialysis-dependent chronic kidney disease, as well as secondary indications including drug interaction potentiation and coronavirus-associated acute respiratory distress syndrome. Recruitment statuses across these protocols encompass active, completed, suspended, and withdrawn studies.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07086755 | RECRUITING | Nonintubated Acute Respiratory Distress Syndrome (ARDS); Pathogen-associated Lung Injury |
Paul Potnuru |
2025-10-23 | PHASE2; PHASE3 |
| NCT07565701 | NOT_YET_RECRUITING | Anemia Associated With Chronic Kidney Disease |
Geoff Block |
2026-04 | PHASE3 |
| NCT07537816 | NOT_YET_RECRUITING | Renal Anemia |
Mackay Memorial Hospital |
2026-04-15 | PHASE4 |
| NCT06901505 | COMPLETED | Anemia of Chronic Kidney Disease |
Akebia Therapeutics |
2025-07-24 | PHASE3 |
| NCT05082571 | WITHDRAWN | Anemia of Chronic Kidney Disease |
Akebia Therapeutics |
2025-01 | PHASE3 |
| NCT05082584 | WITHDRAWN | Anemia of Chronic Kidney Disease |
Akebia Therapeutics |
2025-01 | PHASE3 |
| NCT06520826 | ACTIVE_NOT_RECRUITING | Anemia of Chronic Kidney Disease |
USRC Kidney Research |
2024-11-20 | PHASE3 |
| NCT05082584 | Suspended | Anemia of Chronic Kidney Disease |
Akebia Therapeutics |
2025-01 | Phase 3 |
| NCT05082571 | Suspended | Anemia of Chronic Kidney Disease |
Akebia Therapeutics |
2025-01 | Phase 3 |
| NCT04707768 | COMPLETED | Anemia Associated With Chronic Kidney Disease (CKD) |
Akebia Therapeutics |
2021-06-18 | PHASE3 |
| NCT04478071 | COMPLETED | Acute Respiratory Distress Syndrome; Coronavirus Infection |
The University of Texas Health Science Center, Houston |
2020-08-22 | PHASE2 |
| NCT04313153 | COMPLETED | Anemia |
Akebia Therapeutics |
2020-05-27 | PHASE3 |
| NCT04299633 | COMPLETED | Healthy Volunteers |
Akebia Therapeutics |
2020-06-15 | PHASE1 |
| NCT02680574 | COMPLETED | Anemia; Non-Dialysis-Dependent Chronic Kidney Disease |
Akebia Therapeutics |
2016-02 | PHASE3 |
| NCT03799627 | COMPLETED | Anemia; Dialysis-dependent Chronic Kidney Disease |
Akebia Therapeutics |
2019-01-31 | PHASE2 |
| NCT02648347 | COMPLETED | Anemia; Non-Dialysis-Dependent Chronic Kidney Disease |
Akebia Therapeutics |
2015-12 | PHASE3 |
| NCT03992066 | COMPLETED | Anemia Associated With Chronic Kidney Disease |
Akebia Therapeutics |
2019-05-28 | PHASE1 |
| NCT02865850 | COMPLETED | Anemia; Dialysis-Dependent Chronic Kidney Disease |
Akebia Therapeutics |
2016-07 | PHASE3 |
| NCT02892149 | COMPLETED | Anemia; Dialysis-Dependent Chronic Kidney Disease |
Akebia Therapeutics |
2016-08 | PHASE3 |
| NCT03992066 | Completed | Anemia Associated With Chronic Kidney Disease |
Akebia Therapeutics |
2019-05-28 | Phase 1 |
| NCT03799627 | Completed | Anemia|Dialysis-dependent Chronic Kidney Disease |
Akebia Therapeutics |
2019-01-31 | Phase 2 |
| NCT03801733 | COMPLETED | Drug Interaction Potentiation |
Akebia Therapeutics |
2018-06-17 | PHASE1 |
| NCT03789032 | COMPLETED | Drug Interaction Potentiation; Pharmacokinetics |
Akebia Therapeutics |
2018-10-03 | PHASE1 |
| NCT03799848 | COMPLETED | Hepatic Impairment |
Akebia Therapeutics |
2018-06-12 | PHASE1 |
| NCT03657290 | COMPLETED | Healthy |
Akebia Therapeutics |
2018-08-03 | PHASE1 |
| NCT03789032 | Completed | Drug Interaction Potentiation|Pharmacokinetics |
Akebia Therapeutics |
2018-10-03 | Phase 1 |
| NCT03801759 | COMPLETED | Drug Interaction Potentiation |
Akebia Therapeutics |
2018-07-20 | PHASE1 |
| NCT03801746 | COMPLETED | Drug Interaction Potentiation |
Akebia Therapeutics |
2018-07-20 | PHASE1 |
| NCT03639155 | COMPLETED | Healthy |
Akebia Therapeutics |
2018-04-12 | PHASE1 |
| NCT03140722 | TERMINATED | Anemia; Dialysis-Dependent Chronic Kidney Disease |
Akebia Therapeutics |
2017-05-02 | PHASE2 |
| NCT03242967 | WITHDRAWN | Anemia; Dialysis-Dependent Chronic Kidney Disease |
Akebia Therapeutics |
2017-08 | PHASE3 |
| NCT03054350 | COMPLETED | Anemia; Dialysis Dependent Chronic Kidney Disease |
Akebia Therapeutics |
2016-12 | PHASE2 |
| NCT03054337 | COMPLETED | Anemia; Non-dialysis Dependent Chronic Kidney Disease |
Akebia Therapeutics |
2016-10 | PHASE2 |
| NCT04707573 | COMPLETED | Chronic Kidney Disease |
Akebia Therapeutics |
2010-07-08 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-08-10)
Check the
Vadadustat
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.