Several clinical trials evaluate hippuric acid as a uremic toxin or metabolic biomarker across conditions such as chronic kidney disease, uremic toxin clearance, exercise-induced muscular injury, inborn urea cycle disorders, and acne vulgaris. These Phase 1 and unassigned-phase studies—sponsored by academic medical centers, non-profit organizations, and pharmaceutical entities including GlaxoSmithKline and Baylor College of Medicine—range from currently recruiting and not yet recruiting to completed investigations assessing peritoneal dialysis systems and topical pharmacokinetics. Overall, these trials leverage hippuric acid levels to evaluate metabolic clearance, renal dysfunction, and therapeutic detoxification efficiency.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06314503 | Recruiting | Renal Insufficiency Chronic|Kidney Failure Chronic|Chronic Kidney Diseases |
UMC Utrecht|European Commission Horizon 2020|Dutch Kidney Foundation|Health Holland|Nanodialysis Ltd|Università degli studi di Modena e Reggio Emilia (UNIMORE)|Servicio Madrileno De Salud (SERMAS)|PPI Healthcare Consulting Ltd |
2024-01-22 | Not Applicable |
| NCT06002529 | Not yet recruiting | To Evaluate the Clearance Rate of Uremic Toxin by HFR |
RenJi Hospital |
2023-08-18 | Not Applicable |
| NCT05184855 | Completed | Muscular Injury |
Appalachian State University |
2021-12-01 | Not Applicable |
| NCT02111200 | Completed | Urea Cycle Disorders Inborn |
Baylor College of Medicine |
2014-09 | Not Applicable |
| NCT01527123 | Completed | Acne Vulgaris |
GlaxoSmithKline |
2012-02-28 | Phase 1 |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Mechanism and Biochemical Profile
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>).