Geneuity Clinical Research Services announces the recent validation and use in clinical trials of two human biomarker assays that play a key role in the early detection of kidney damage.

These quantitative, predictive measurements for the biomarkers NGAL (Neutrophil Gelantinase-associated lipocalin) and KIM-1 (kidney injury molecule 1) will assist our drug development clients in initial Phase I dosing and Phase 2 proof of concept clinical trials as well as play a crucial role in Phase 3 efficacy/safety trials for early detection of drug toxicity. Rapid, cost-effective biomarker analysis is critical to pharmaceutical and biotechnology companies for enhancing discovery to market performance. Screening patients enrolled in early Phase clinical trials for kidney damage due to drug toxicity is of particular importance as drug concentration in the kidney is 1000 fold higher than in circulating plasma.

The urine biomarkers NGAL and KIM-1 can detect potential drug-induced damage to kidney cells in human clinical trials at a much earlier stage of renal toxicity than the nonspecific BUN (Blood Urea Nitrogen) and serum creatinine markers traditionally used to detect kidney damage. Serum creatinine and BUN have poor sensitivity and specificity, are expressed in a steady state, and lag behind both renal injury and renal recovery. These results delay detection of damage and discontinuation of nephrotoxic agents.

Of note, new safety initiatives and general acceptance of these markers as better indicators of early kidney damage have recently led regulatory agencies such as the U.S. Food and Drug Administration (FDA) to accept biomarker data as a measurement of kidney damage as part of the drug approval process. This information greatly improves the efficiency of clinical trials by allowing drug developers to either adjust dosage levels or cease development of toxic compounds at an earlier stage, said Dr. Ranee Taylor, director of Business Development for Geneuity.

The use of biomarkers such as NGAL and KIM1 in human clinical trials will become routine when there is concern that a drug might be nephrotoxic. In addition to use in clinical trials, NGAL and KIM1 levels are predictive for graft function after renal transplant and for assessing the severity of kidney damage resulting from diseases such as diabetes, viral infection, autoimmune conditions and hypertension.


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