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http://www.astellas.com/

Japanese pharmaceutical company formed from the merger of Yamanouchi Pharmaceutical Co., Ltd. and Fujisawa Pharmaceutical Co., Ltd. Astellas' franchise areas are urology, immunology (transplantation), dermatology, cardiology, and infectious disease. Priority areas for R&D are infectious diseases, diabetes, gastrointestinal diseases, oncology, and diseases of the central nervous system. The company's headquarters are in Tokyo, with research centers in Tsukuba and Osaka. Clinical development is centered in Northbrook, Illinois and Leiderdorp, Netherlands. Combined revenues of the two pre-merger companies were $7.9 billion in 2004. Worldwide the company employs about 17,000 people. (Wikipedia)

Proper citation: Astellas Pharma Inc. (RRID:SCR_003769) Copy   

•   Source: SciCrunch Registry

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/UCM285010.pdf

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   

•   Source: SciCrunch Registry

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/UCM382536.pdf

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   

•   Source: SciCrunch Registry

http://clinicaltrials.gov/show/NCT00143949

Randomized, multicenter, double-blind study to determine if renin angiotensin medications, either losartan (angiotensin II blocker) or enalapril (converting enzyme inhibitor), can prevent or delay the onset of diabetic kidney disease in patients with type 1 diabetic patients who do not have hypertension, diabetic nephropathy, or predictive levels of microalbuminuria. Two hundred eight five patients ages 16-61 with 2-20 yrs of Type 1 Diabetes Mellitus and no renal functional abnormalities were randomized into a parallel, double-blind, placebo-controlled study involving 3 groups (95 patients/group). Each group received an angiotensin-converting enzyme inhibitor (ACEI) (enalapril), or an angiotensin II receptor blocker (Losartan), or placebo. All patients had their usual Diabetes Mellitus (DM) management. Baseline studies included measures of glomerular filtration rate (GFR), urinary albumin excretion rate (UAE), blood pressure (BP), and a percutaneous renal biopsy. Patients were followed by quarterly measures of BP, HbA1C, UAE, and drug compliance. There were annual measures of GFR and a repeat renal biopsy after 5 yrs in the study. The main endpoint is kidney structural changes over time, especially mesangial fractional volume (v(Mes/glom)). Secondary endpoints will be other DN structural measures and measures of kidney function (UAE, GFR). These studies will determine whether rennin angiotensin system blockage in the early stages of DN can prevent the early kidney structural changes in this important disorder. Ancillary studies will evaluate the effects of treatment group on the development and progression of diabetic retinopathy and will develop predictors of study participants'''' compliance. Baseline, 2.5 and 5 year retinal fundus photographs in the RASS patients were obtained.

Proper citation: Renin Angiotensin System Study (RRID:SCR_013385) Copy   

•   Source: SciCrunch Registry

http://c-path.org/programs/pkd/

Consortium to develop evidence supporting the use of imaging Total Kidney Volume (TKV) as a prognostic biomarker that predicts the progression of Autosomal Dominant Polycystic Kidney Disease (ADPKD) to select patients likely to respond to therapy into clinical trials. It aims to replace the currently used measurement of glomerular filtration rate (GFR). Scientists will use the data collected to develop a disease progression model that will evaluate the relationship between TKV and the known complications of ADPKD, including rate of loss of kidney function, hypertension, gross hematuria, kidney stones, urinary tract infections, development of end-stage renal disease, and mortality. These analyses will be used to support the regulatory qualification of TKV as an accepted measure for assessing the progression of ADPKD in clinical trials in which new therapies are tested. PKDOC has the following goals: # Develop standard clinical data elements and definitions that are specific to ADPKD # Create a database of aggregated data from existing multiple, longitudinal, and well-characterized research registries maintained over decades by the leading institutions in ADPKD clinical investigation # Advance and harmonize the missions of regulatory agencies by creating tools that help with the evaluation of new pharmaceutical compounds # Develop a quantitative disease progression model to examine the linkage between TKV and disease outcomes

Proper citation: Polycystic Kidney Disease Outcomes Consortium (RRID:SCR_003674) Copy   

•   Source: SciCrunch Registry

http://clinicaltrials.gov/

Registry and results database of federally and privately supported clinical trials conducted in United States and around world. Provides information about purpose of trial, who may participate, locations, and phone numbers for more details. This information should be used in conjunction with advice from health care professionals.Offers information for locating federally and privately supported clinical trials for wide range of diseases and conditions. Research study in human volunteers to answer specific health questions. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings. ClinicalTrials.gov contains trials sponsored by National Institutes of Health, other federal agencies, and private industry. Studies listed in database are conducted in all 50 States and in 178 countries.

Proper citation: ClinicalTrials.gov (RRID:SCR_002309) Copy   

•   Source: SciCrunch Registry

http://www.kegg.jp/

Integrated database resource consisting of 16 main databases, broadly categorized into systems information, genomic information, and chemical information. In particular, gene catalogs in completely sequenced genomes are linked to higher-level systemic functions of cell, organism, and ecosystem. Analysis tools are also available. KEGG may be used as reference knowledge base for biological interpretation of large-scale datasets generated by sequencing and other high-throughput experimental technologies.

Proper citation: KEGG (RRID:SCR_012773) Copy   

•   Source: SciCrunch Registry