Phase II year
2010
(last award dollars: 2011)
Kidney disease in the United States has been described as an epidemic. More than 20 million patients have chronic kidney disease (CKD) and these numbers are increasing annually. As a result, the number of patients with end-stage renal disease (ESRD) is expected to double between 1999 and 2010. These increases in CKD and ESRD are associated with significant morbidity, mortality and healthcare costs. Early detection and treatment of kidney disease has been shown to improve outcomes, but kidney disease is often under diagnosed resulting in lost opportunities to treat. The importance of early diagnosis and treatment of kidney disease has been extensively reviewed and published as a K/DOQI clinical practice guideline by the National Kidney Foundation. Monitoring changes in glomerular filtration rate (GFR) provides the best means for early detection of kidney disease. The test that is most widely used in the US to screen abnormalities in GFR is serum creatinine. However, estimated GFR values using serum creatinine have limited diagnostic value over methods that directly measured GFR using an ideal filtration marker, such as inulin. This Phase II application seeks support to further develop a novel readout system, based on immunoassay technology, to directly measure GFR. As demonstrated during Phase I, our test is accurate, simple-to-use, inexpensive and can be widely assessable. The test utilizes FDA-cleared compounds that are known to be GFR markers. As a result, our proposed GFR test will be able to more quickly enter the marketplace.
Public Health Relevance: The project will further develop a diagnostic test to measure kidney function. The test will utilize well-known and widely available analytical technology and will utilize clinically available compounds. Therefore, this test will be able to quickly enter the market-place.
Thesaurus Terms: 1,3-Benzenedicarboxamide, 5-(Acetyl(2,3-Dihydroxypropyl)Amino)-N,N'-Bis(2,3-Dihydroxypropyl)-2,4,6-Triiodo-; 21+ Years Old; 4h-Imidazol-4-One, 2-Amino-1,5-Dihydro-1-Methyl-; Address; Adoption; Adult; American; Arm; Blood; Blood Serum; Crea; Certification; Characteristics; Chronic Kidney Failure; Chronic Renal Disease; Clinical; Clinical Practice Guideline; Clinical Practice Guidelines; Clinical Research; Clinical Study; Clinical Trials; Clinical Trials, Unspecified; Collection; Complex; Controlled Clinical Trials; Creatinine; Data; Detection; Development; Development And Research; Diagnosis; Diagnostic; Diagnostic Method; Diagnostic Procedure; Diagnostic Technique; Diagnostic Tests; Dietary Intervention; Disease; Disorder; Documentation; Dose; Drugs; Elisa; Esrd; Early Diagnosis; End Stage Renal Failure; End-Stage Kidney Disease; Ensure; Enzyme-Linked Immunosorbent Assay; Epidemic; Epidemiology; Equipment; Fda Approved; Filtration; Foundations; Fractionation, Filtration; Funding; Future; Gadolinium Dtpa; Gadolinium Diethylenetriaminepenta-Acetic Acid; Gadopentetic Acid; Gd-Dtpa; Generations; Glomerular Filtration Rate; Glycans; Goals; Head; Health Care Costs; Health Costs; Healthcare Costs; Human; Human, Adult; Human, General; Immunoassay; Inulin; Investigators; Iohexol; Iohexol 350; Kidney; Kidney Diseases; Kidney Failure, Chronic; Laboratories; Legal Patent; Mr Imaging; Mr Tomography; Mri; Magnetic Resonance Imaging; Magnetic Resonance Imaging Scan; Man (Taxonomy); Man, Modern; Marketing; Measurement; Measures; Medical; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; Medication; Methods; Moab, Clinical Treatment; Molecular Weight; Monitor; Monoclonal Antibodies; Morbidity; Morbidity - Disease Rate; Mortality; Mortality Vital Statistics; Nmr Imaging; Nmr Tomography; Nephropathy; Nuclear Magnetic Resonance Imaging; Nutrition Interventions; Nutritional Interventions; Outcome; Patents; Patients; Performance; Pharmaceutic Preparations; Pharmaceutical Agent; Pharmaceutical Preparations; Pharmaceuticals; Pharmacologic Substance; Pharmacological Substance; Phase; Polysaccharides; Principal Investigator; Procedures; Process; Programs (Pt); Programs [publication Type]; Publishing; R & D; R&D; Radioactivity; Reagent; Renal Disease; Renal Disease, End-Stage; Renal Failure, Chronic; Renal Clearance Function; Renal Function; Reporting; Research; Research Personnel; Researchers; Reticuloendothelial System, Blood; Risk; Sbir; Sbirs (R43/44); Sales; Sampling; Sensitivity And Specificity; Serum; Small Business Innovation Research; Small Business Innovation Research Grant; Study Section; System; System, Loinc Axis 4; Technology; Testing; Time; United States; Upper Arm; Urinary System, Kidney; Urinary System, Urine; Urine; Validation; Zeugmatography; Adult Human (21+); Base; Chronic Kidney Disease; Clinical Investigation; Commercialization; Cross Reactivity; Dalton; Design; Designing; Disease/Disorder; Drug/Agent; Early Detection; Improved; Kidney Disorder; Kidney Function; Manufacturing Process; Novel; Pre-Clinical; Preclinical; Preference; Programs; Public Health Relevance; Quality Assurance; Renal; Renal Clearance; Renal Disorder; Research And Development; Success; Validation Studies
