HA130 Clinical Trials

Size	Price	Qty
5mg	USD 127
25mg	USD 379

Clinical Trials

Several clinical trials evaluate HA130-associated interventions across renal disease stages and uremic complications, including chronic kidney disease stage 5D, end-stage renal disease on dialysis, refractory pruritus, hyperparathyroidism, ostalgia, and chronic inflammatory syndromes. Ranging from Phase 2 and Phase 3 protocols to unspecified phase designations, these studies are sponsored by academic and medical institutions such as Sun Yat-sen University and Botkin Hospital. Currently completed or actively recruiting, these investigations assess interventions including sorption technologies and combination hemodialysis with hemoperfusion.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07123909	RECRUITING	CKD (Chronic Kidney Disease) Stage 5D; Uremia; Chronic; Uremic; Toxemia; Inflammation Chronic; Hemodialysis; Inflammation Biomarkers; Dialysis Related Complication; Anemia Associated With End Stage Renal Disease	Botkin Hospital	2025-06-01
NCT02461953	COMPLETED	Renal Dialysis; Hemoperfusion; Quality of Life	Chinese PLA General Hospital	2015-06
NCT02747979	COMPLETED	Hyperparathyroidism; Refractory Pruritus; Ostalgia; Insomnia	Sun Yat-sen University	2009-04	PHASE2; PHASE3

(data from https://clinicaltrials.gov, updated on 2025-12-10)

Check the HA130 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

HA130 acts as a potent and selective inhibitor of autotaxin (ATX) with an IC50 of 28 nM, directly blocking the lysophospholipase D activity responsible for generating lysophosphatidic acid (LPA). By suppressing LPA-mediated downstream signaling pathways that promote cell proliferation, tissue fibrosis, and inflammatory cascades, this target inhibition modulates signaling networks relevant to chronic kidney disease, uremic pruritus, and systemic inflammation.

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>).