Doxercalciferol Clinical Trials

Size	Price	Qty
1mg	USD 147
5mg	USD 370

Clinical Trials

A completed Phase 1 clinical trial, sponsored by industry partners OPKO IP Holdings II Inc. and OPKO Health Inc., investigated the therapeutic application of doxercalciferol. The randomized cross-over study compared single doses of doxercalciferol injection and CTAP201 injection in patients with chronic kidney disease, secondary hyperparathyroidism, chronic renal insufficiency, and chronic renal failure. This research provides essential early-stage safety and dose-determination data for managing renal metabolic disorders.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00792857	Completed	Chronic Kidney Disease\|Secondary Hyperparathyroidism\|Chronic Renal Insufficiency\|Chronic Renal Failure	OPKO IP Holdings II Inc.\|OPKO Health Inc.	2008-11	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Doxercalciferol, a synthetic 1α-hydroxyvitamin D2 analog, undergoes metabolic activation to bind vitamin D receptors, subsequently suppressing transcriptional pathways governing parathyroid hormone synthesis and secretion in parathyroid cells. This targeted suppression reduces pathologically elevated parathyroid hormone levels, providing essential clinical utility in preventing metabolic bone disease in patients with secondary hyperparathyroidism and chronic kidney disease.

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>).