Creatinine Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

Several clinical trials evaluate or utilize creatinine across diverse conditions, including acute kidney injury, contrast-induced nephropathy, renal insufficiency, anti-neutrophil cytoplasmic antibody-associated vasculitis, Werner syndrome, and renal transplantation. These studies encompass Phase 2, Phase 4, and unassigned phase designs, with recruitment statuses categorized as withdrawn or not yet recruiting. Sponsored by academic and pharmaceutical entities—including Maastricht University Medical Center, NovelMed Therapeutics, PRG Science & Technology Co. Ltd., and University Hospital Geneva—they assess renal parameters and targeted therapies in these patient populations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04598516	Withdrawn	Acute Kidney Injury (Nontraumatic)\|Contrast-induced Nephropathy\|Renal Insufficiency	Maastricht University Medical Center	2097-11-01	--
NCT04597892	Withdrawn	Renal Insufficiency\|Acute Kidney Injury\|Contrast-induced Nephropathy	Maastricht University Medical Center	2097-05-01	--
NCT06226662	Not yet recruiting	Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis	NovelMed Therapeutics	2025-06	Phase 2
NCT05847179	Not yet recruiting	Werner Syndrome	PRG Science & Technology Co. Ltd.	2025-01-01	Phase 2
NCT05935293	Not yet recruiting	Renal Transplantation\|Dexmedetomidine	Eduardo Schiffer\|University Hospital Geneva	2024-12-01	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Creatinine is a physiological breakdown product of muscle creatine phosphate that accumulates in systemic circulation and undergoes passive glomerular filtration without substantial tubular reabsorption or metabolic modification. Assessment of systemic creatinine accumulation directly reflects changes in renal clearance efficiency, rendering serum creatinine concentration an indispensable biomarker of glomerular filtration rate in conditions such as acute kidney injury, renal insufficiency, and post-renal transplantation monitoring.

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>).