Fenoldopam mesylate Clinical Trials

Size	Price	Qty
10mg	USD 147
200mg	USD 690

Clinical Trials

Multiple clinical trials spanning Phases 1 through 4 evaluate fenoldopam primarily for acute kidney injury, renal failure, cardiac complications during cardiopulmonary bypass, salt-sensitive hypertension, and pediatric acute renal failure. Sponsored predominantly by academic hospitals and research foundations, these investigations encompass recruitment statuses ranging from completed Phase 2 and Phase 3 studies to terminated or withdrawn protocols. Collectively, this research assesses the drug's efficacy in perioperative organ perfusion and postoperative renal preservation.

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
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NCT01073189	WITHDRAWN	Kidney Failures, Acute	Southeast Renal Research Institute	2010-04	PHASE4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NCT00286403	WITHDRAWN	Acute Renal Failure	Southeast Renal Research Institute	2008-08	PHASE2; PHASE3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
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)

Check the Fenoldopam mesylate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fenoldopam acts as a selective dopamine-1 receptor agonist, activating adenylate cyclase to elevate intracellular cyclic AMP levels, which induces vascular smooth muscle relaxation and renal arteriolar vasodilation. This signaling cascade increases renal blood flow and promotes natriuresis, offering protective therapeutic effects against acute kidney injury and postoperative renal dysfunction in patients undergoing cardiac surgery with cardiopulmonary bypass.

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>).