Iron Dextran Clinical Trials

Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate iron dextran across therapeutic settings including iron deficiency anemia, pregnancy-associated anemia, iron malabsorption, chronic kidney disease, chemotherapy-induced anemia, and prematurity-related iron deficiency. Sponsored by academic medical centers, university hospitals, and pharmaceutical organizations, these investigations assess intravenous dosing regimens, safety, and therapeutic outcomes. Study statuses encompass completed, recruiting, active not recruiting, withdrawn, and suspended.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05340465	RECRUITING	Prematurity; Iron-deficiency; Iron Deficiency Anemia; Iron Malabsorption	University of Washington	2022-11-27	PHASE2
NCT07706582	ACTIVE_NOT_RECRUITING	Iron Deficiency Anemia (IDA); ESRD (End Stage Renal Disease)	Beni-Suef University	2025-11-02	PHASE2
NCT06508827	WITHDRAWN	Anemia, Iron Deficiency; Melanoma	Indiana University	2025-05	PHASE2
NCT05292001	RECRUITING	Acute Blood Loss Anemia; Fracture	Oregon Health and Science University	2022-06-01	PHASE4
NCT05960227	COMPLETED	Anemia, Iron Deficiency; Acute Kidney Injury	Hospital Civil de Guadalajara	2023-01-06	PHASE2
NCT05167734	COMPLETED	Anemia; Critical Illness	Mayo Clinic	2021-11-30	PHASE2
NCT05714176	UNKNOWN	CKD - Chronic Kidney Disease	Menoufia University	2023-02-01	PHASE4
NCT05047211	COMPLETED	Anemia, Iron Deficiency; Delivery Complication	The University of Texas Medical Branch, Galveston	2021-10-07	PHASE4
NCT02889133	COMPLETED	Iron Deficiency	Columbia University	2017-01
NCT03438227	COMPLETED	Iron Deficiency Anemia of Pregnancy; Iron Malabsorption	Indiana University	2018-04-15	PHASE4
NCT02731378	UNKNOWN	Chemotherapy-induced Anaemia	Shanghai East Hospital	2016-12	PHASE4
NCT03279536	COMPLETED	Iron Deficiency Anemia	Woman's Health University Hospital, Egypt	2017-11-01	PHASE1; PHASE2
NCT03212781	COMPLETED	Anemia	Assiut University	2016-06	PHASE3
NCT02038023	COMPLETED	Pregnancy	Auerbach Hematology Oncology Associates P C	2013-07	PHASE2
NCT03286205	Withdrawn	Anemia Iron Deficiency	Sutter Gould Medical Foundation	2015-04-14	Phase 4
NCT02086838	COMPLETED	Treatment of Iron Deficiency Anemia in Pregnancy	Ain Shams University	2013-07	PHASE4
NCT02038023	Completed	Pregnancy	Auerbach Hematology Oncology Associates P C\|Pharmacosmos A/S	2013-07	Phase 2
NCT01290315	COMPLETED	Iron Deficiency Anemia	American Regent, Inc.	2009-08	PHASE2
NCT01307007	COMPLETED	Iron Deficiency Anemia	American Regent, Inc.	2010-09	PHASE2
NCT00704028	COMPLETED	Anemia	American Regent, Inc.	2008-06	PHASE3
NCT00593619	SUSPENDED	Iron Deficiency Anemia; Perioperative Blood Conservation	London Health Sciences Centre	2008-01	PHASE4
NCT00401544	COMPLETED	Anemia; Non-Myeloid Malignancies	Amgen	2006-12	PHASE2
NCT00482716	UNKNOWN	Anemia; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Unspecified Adult Solid Tumor, Protocol Specific	St. Bartholomew's Hospital	2007-01	PHASE3
NCT01151592	WITHDRAWN	Iron Deficiency Anemia	American Regent, Inc.		PHASE4

(data from https://clinicaltrials.gov, updated on 2026-05-26)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Upon parenteral uptake, iron dextran undergoes endocytosis by reticuloendothelial macrophages, releasing elemental ferric iron to bind circulating transferrin and ferritin to restore intracellular and systemic iron pools. This replenishment of functional iron fuels heme synthesis and erythroid cell proliferation, effectively alleviating systemic iron depletion in clinical conditions such as iron deficiency anemia and anemia associated with chronic kidney disease or pregnancy.

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>).