Urea Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Several clinical trials evaluate therapeutic devices and management strategies in patients with renal failure, chronic kidney disease, cardiorenal syndrome, hypotension, left ventricular dysfunction, and heart failure. Spanning Phase 2, Phase 3, and protocols designated with a phase status of Not Applicable, these research initiatives are led by academic institutions and industry sponsors, including the University of Michigan and Fresenius Medical Care. Currently, the recruitment statuses for these studies are reported as suspended or not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04589065	Suspended	Heart Failure\|Chronic Systolic Heart Failure\|Renal Failure\|Cardiorenal Syndrome	Lenar Yessayan\|University of Michigan	2024-09	Not Applicable
NCT06405555	Not yet recruiting	Heart Failure With Reduced Ejection Fraction\|Hypotension\|LV Dysfunction	Ottawa Heart Institute Research Corporation	2024-08-01	Phase 2\|Phase 3
NCT06390592	Not yet recruiting	Renal Failure\|Chronic Kidney Disease	Fresenius Medical Care Deutschland GmbH\|Alcedis GmbH	2024-06	Not Applicable

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Urea functions as an endogenous osmolyte and metabolite that interacts with renal urea transporters to establish trans-epithelial osmotic gradients within the inner medullary collecting duct. By modulating intratubular fluid osmolarity and passive water reabsorption, urea plays a pivotal role in maintaining systemic fluid homeostasis, solute clearance, and osmotic balance in clinical conditions such as heart failure, cardiorenal syndrome, and chronic renal failure.

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>).