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Urinary kidney biomarkers (KIM-1, albumin, total protein, 2-microglobulin, cystatin C, clusterin and trefoil factor-3) that are considered acceptable biomarkers for the detection of acute drug-induced nephrotoxicity in rats and can be included along with traditional clinical chemistry markers and histopathology in toxicology studies. These biomarkers may be used voluntarily as additional evidence of nephrotoxicity in nonclinical safety assessment studies to complement the standard data (BUN and sCr). In ROC analyses, some of these biomarkers showed better sensitivity and specificity than BUN and sCr relative to histopathological alterations considered to be the gold standard when tested with a limited number of nephrotoxicant and control compounds.
Proper citation: PSTC Nephrotoxicity Biomarkers (RRID:SCR_003709) Copy
http://www.asn-online.org/khi/
Consortium that brings together the kidney community (patient advocacy groups, industry, government agencies, and professional organizations) to overcome existing challenges, including regulatory and nonregulatory barriers, and optimize the development and safety of products that impact kidney health including drugs, devices, biologics, and food products. The goals of the consortium are to: * Facilitate dialogue and research that informs regulatory processes with regard to the kidney health of patients being treated for kidney-related as well as other diseases. * Assess current medical therapies and diagnostics to identify areas in need of greater innovation and/or better defined regulatory pathways. * Develop innovative and efficient trial designs appropriate to answer the most important questions related to kidney health. * Establish expert consensus around common terminology and key definitions related to kidney health. * Develop approaches to the systematic collection of retrospective or prospective data, such as registries and/or global databases, and establishment of data standards. * Coordinate think tanks, public forums, educational exchanges, and other events to promote discussion and updates on topics in kidney health pertaining to drug, device, biologics, and food product development and evaluation. * Create transparent infrastructure and processes that facilitate collaboration and communication among the greater nephrology community and the FDA, including: * Seek input from all stakeholders (including nephrologists and other health professionals, patient groups, industry, the National Institutes of Health, the Centers for Medicare and Medicaid Services, the Health Resources and Services Administration, and other federal agencies). * Leverage previously conducted and ongoing clinical studies, research infrastructure, and databases. * Create an open and efficient mechanism for encouraging and objectively evaluating potential projects submitted to KHI. * Involve consortium members in the selection and execution of projects. * Establish systems to optimize post-market surveillance of products that affect kidney health, either intentionally or via adverse drug reactions. * Author journal articles and white papers regarding key issues, describing opportunities and challenges and proposing solutions, as well as promoting execution of these solutions.
Proper citation: Kidney Health Initiative (RRID:SCR_003869) Copy
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM380961.pdf
An electronically administered patient-reported outcome (PRO) measure that is a qualified measure of symptoms of acute bacterial exacerbation of chronic bronchitis in patients with chronic obstructive pulmonary disease (ABECB-COPD), for use in phase 2 trials. Refer to the proposed context of use, http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/UCM399682.pdf. Its intent to quantify frequency, severity, and duration of acute exacerbations in clinical trials of COPD including those with chronic bronchitis. It is designed as an electronic diary made up of fourteen items to be completed by the patient each evening just prior to bedtime. (An item-reduction statistical analysis narrowed the questions from 23 to 14.) For more information see, http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/UCM386248.pdf
Proper citation: Exacerbations of Chronic Pulmonary Disease Tool (RRID:SCR_003718) Copy
Serum / plasma biomarkers, Cardiac troponins T (cTnT) and I (cTnI), in safety assessment studies for rats, dogs, and monkeys are qualified biomarkers for the following contexts of use: # When there is previous indication of cardiac structural damage with a particular drug, cardiac troponin testing can help estimate a lowest toxic dose or a highest non-toxic dose to help choose doses for human testing. In this case, cardiac troponins may serve as a clinical chemistry correlate to the histology. For example, in a safety assessment study, lower doses without increases in cardiac troponins may be used to support a no observed effect level (NOEL) identified by histology. # When there is known cardiac structural damage with a particular pharmacologic class of a drug and histopathologic analyses do not reveal structural damage, circulating cardiac troponins may be used to support or refute the inference of low cardiotoxic potential. # When unexpected cardiac structural toxicity is found in a nonclinical study, the retroactive (reflex) examination of serum or plasma from that study for cardiac troponins can be used to help determine a no observed adverse effect level (NOAEL) or lowest observed adverse effect level (LOAEL). The results of this testing may support inclusion of cardiac troponin testing in subsequent safety assessment studies.
Proper citation: O'Brien Reagan York and Jacobsen Drug-induced Cardiotoxicity Biomarkers (RRID:SCR_003717) Copy
Urinary kidney biomarkers, Clusterin and Renal Papillary Antigen-1 (RPA-1), that sponsors may use to determine more conservative NOAELs for estimating starting doses in the initial human clinical trial of a drug that displays nonclinical nephrotoxicity as determined by histopathology. When tested with a limited number of nephrotoxic compounds, the Receiver Operating Characteristic (ROC) analyses showed that urinary clusterin and renal papillary antigen-1 (RPA-1) have better sensitivity and specificity than BUN and creatinine for the detection of specific kidney pathologies in male rats. Clusterin and RPA-1 provide additional and complementary information to BUN, serum creatinine (sCr), and histopathology for the detection of acute drug-induced nephrotoxicity in safety assessment studies.
Proper citation: ILSI HESI Drug-induced Nephrotoxicity Biomarkers (RRID:SCR_003716) Copy
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