Clinical Trials
Multiple clinical trials spanning Phase 1 through Phase 4 evaluate fenoldopam's therapeutic efficacy in acute kidney injury, renal failure, salt-sensitive hypertension, splanchnic underperfusion, and perioperative complications during cardiac surgery requiring cardiopulmonary bypass. Sponsored by academic institutions and government organizations—including the University of Virginia, National Institutes of Health, and Università Vita-Salute San Raffaele—these initiatives comprise completed Phase 2 and Phase 3 studies on postoperative renal preservation alongside terminated or unverified protocols. Collectively, these investigations assess the drug's prophylactic and renal-protective potential across diverse clinical indications, including acute renal impairment in infants with patent ductus arteriosus.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT02620761 | TERMINATED | Patent Ductus Arteriosus (PDA); Acute Kidney Injury (AKI) |
Medical College of Wisconsin |
2019-02-06 | PHASE2; PHASE3 |
| NCT02620761 | Terminated | Patent Ductus Arteriosus (PDA)|Acute Kidney Injury (AKI) |
Medical College of Wisconsin |
2019-02-06 | Phase 2|Phase 3 |
| NCT00557219 | TERMINATED | Acute Renal Failure |
Medical University of Gdansk |
2008-04 | PHASE3 |
| NCT01690832 | UNKNOWN | Coronary Artery Disease |
University of Roma La Sapienza |
2012-09 | PHASE4 |
| NCT00621790 | COMPLETED | Acute Renal Failure |
Università Vita-Salute San Raffaele |
2008-02 | PHASE3 |
| NCT01073189 | WITHDRAWN | Kidney Failures, Acute |
Southeast Renal Research Institute |
2010-04 | PHASE4 |
| NCT00982527 | COMPLETED | Kidney Failure, Acute |
Bambino Gesù Hospital and Research Institute |
2009-09 | PHASE3 |
| NCT00743106 | TERMINATED | Partial Nephrectomy |
The Cleveland Clinic |
2002-09 | |
| NCT00747331 | COMPLETED | Cardiac Complications; Cardiopulmonary Bypass |
IRCCS Policlinico S. Donato |
2008-09 | PHASE4 |
| NCT00286403 | WITHDRAWN | Acute Renal Failure |
Southeast Renal Research Institute |
2008-08 | PHASE2; PHASE3 |
| NCT00592150 | UNKNOWN | Hypertension |
University of Virginia |
2007-06 | PHASE1 |
| NCT00592150 | Unknown status | Hypertension |
University of Virginia|National Institutes of Health (NIH) |
2007-06 | Phase 1 |
| NCT00467181 | COMPLETED | Cardiac Surgery With Cardiopulmonary Bypass |
Summa Health System |
2005-01 | PHASE2 |
| NCT00122018 | COMPLETED | Kidney Failure, Acute; Kidney Failure, Chronic; Cardiac Surgical Procedures |
Linda F. Barr, M.D. |
2002-05 | PHASE2 |
| NCT01324245 | COMPLETED | Salt-sensitive Hypertension |
Georgetown University |
2002-11 |
(data from https://clinicaltrials.gov, updated on 2022-09-16)
Compliance for Clinical Use
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>).