Edetate calcium disodium Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Clinical trials evaluating edetate calcium disodium have addressed heavy metal toxicity and supportive cancer care, though all documented studies were ultimately withdrawn. Specifically, a Phase 4 study sponsored by Mt. Sinai Medical Center Miami aimed to investigate gadolinium retention following magnetic resonance imaging in patients with normal kidney function. Meanwhile, a trial with an unclassified phase supported by M.D. Anderson Cancer Center and the National Cancer Institute explored catheter flush solutions to prevent line infections and occlusions in oncology patients.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02421029	Withdrawn	Heavy Metal Toxicity	Mt. Sinai Medical Center Miami	2017-07	Phase 4
NCT00378781	Withdrawn	Cancer	M.D. Anderson Cancer Center\|National Cancer Institute (NCI)		Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Edetate calcium disodium acts as a chelating agent by binding multivalent metal cations through coordination complexes, displacing calcium with lead and other heavy metals possessing higher binding affinity. This chelation forms soluble, non-toxic complexes that prevent toxic metal-protein interactions and promote rapid renal excretion, thereby mitigating physiological damage in heavy metal toxicity and supporting clinical management in toxicological and oncological settings.

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>).