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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

https://glomcon.org

Consortium to bring together clinicians, pathologists, researchers, and biotech innovators to create scalable network of stakeholders interested in helping patients with glomerular kidney disease. Makes collective expertise of its members available for discussion of individual cases, provides infrastructure for biomarker studies, enables genomic research, and facilitates clinical trials.

Proper citation: Glomerular Disease Study & Trial Consortium (RRID:SCR_017264) Copy   

•   Source: SciCrunch Registry

http://www.nncc-exam.org/

Organization that established credentialing mechanisms to promote patient safety and to improve the quality of care provided to nephrology patients. There is a diversity of examinations providing the opportunity for certification at various levels of education, experience, and areas of practice within nephrology nursing. All of the certification examinations are endorsed by American Nephrology Nurses'''' Association (ANNA). The Commission recognizes the value of education, administration, research, and clinical practice in fostering personal and professional growth and currently provides six examinations to validate clinical performance: * The Certified Dialysis Nurse examination * The Certified Dialysis LPN/LVN examination * The Certified Nephrology Nurse examination * The Certified Clinical Hemodialysis Technician * The Certified Clinical Hemodialysis Technician - Advanced * The Certified Nephrology Nurse - Nurse Practitioner

Proper citation: Nephrology Nursing Certification Commission (RRID:SCR_003994) Copy   

•   Source: SciCrunch Registry

http://www.sbur.org/

The Society for Basic Urologic Research (SBUR) is a society of scientists whose expertise includes the study of urologic cancers (prostate, bladder, kidney, testis, penis), the biology of prostate growth, kidney and bladder function, autoimmune urologic diseases, infectious diseases, neuro-urologic diseases, male reproductive biology, infertility and erectile dysfunction. Members include molecular biologists, immunologists, epidemiologists, oncologists, biochemists and clinical urologic scientists. SBUR members serve on a wide variety of advisory panels, study sections, editorial boards and in the pharmaceutical industry. The SBUR organizes two annual meetings to share new findings at a multidisciplinary level, to promote interaction among members and other interested scientists and to highlight new areas of research and funding opportunities. The Society was organized to address the following: * To provide a forum for the presentation and discussion of basic scientific topics related to urology * To develop educational forums concerning scientific advancements related to the field of urology * To promote collaborative investigations among member scientists with an emphasis on the interchange of expertise among clinical and basic scientists * To promote the communication and interests of urologic disease investigators with national funding agencies, industry representatives and academic institutions with regards to urology related research * To serve as a resource for research information and expertise to clinical urologists through the American Urological Association

Proper citation: SBUR - Society for Basic Urologic Research (RRID:SCR_005856) Copy   

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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   

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http://www.cristudy.org/Chronic-Kidney-Disease/Chronic-Renal-Insufficiency-Cohort-Study/

A prospective observational national cohort study poised to make fundamental insights into the epidemiology, management, and outcomes of chronic kidney disease (CKD) in adults with intended long-term follow up. The major goals of the CRIC Study are to answer two important questions: * Why does kidney disease get worse in some people, but not in others? * Why do persons with kidney disease commonly experience heart disease and stroke? The CRIC Scientific and Data Coordinating Center at Penn receives data and provides ongoing support for a number of Ancillary Studies approved by the CRIC Cohort utilizing both data collected about CRIC study participants as well as their biological samples. The CRIC Study has enrolled over 3900 men and women with CKD from 13 recruitment sites throughout the country. Following this group of individuals over the past 10 years has contributed to the knowledge of kidney disease, its treatment, and preventing its complications. The NIDDKwill be extending the study for an additional 5 years, through 2018. An extensive set of study data is collected from CRIC Study participants. With varying frequency, data are collected in the domains of medical history, physical measures, psychometrics and behaviors, biomarkers, genomics/metabolomics, as well as renal, cardiovascular and other outcomes. Measurements include creatinine clearance and iothalamate measured glomerular filtration rate. Cardiovascular measures include blood pressure, ECG, ABI, ECHO, and EBCT. Clinical CV outcomes include MI, ischemic heart disease-related death, acute coronary syndromes, congestive heart failure, cerebrovascular disease, peripheral vascular disease, and composite outcomes. The CRIC Study has delivered in excess of 150,000 bio-samples and a dataset characterizing all 3939 CRIC participants at the time of study entry to the NIDDKnational repository. The CRIC Study will also be delivering a dataset to NCBI''''s Database for Genotypes and Phenotypes.

Proper citation: Chronic Renal Insufficiency Cohort Study (RRID:SCR_009016) Copy   

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http://www.medibeacon.com/preclinical/

Software used to analyze glomerular filtration rate (GFR) measurement from MediBeacon GFR monitor. It is used with the Transdermal Continuous Renal Function Monitor.

Proper citation: MediBeacon Studio Software (RRID:SCR_016252) Copy   

•   Source: SciCrunch Registry

https://hirnetwork.org/consortium/cbds

Consortium that is an independent research initiative of the Human Research Information Network (HIRN). It is using human tissues to discover highly specific biomarkers of beta cell injury in asymptomatic T1D and developing strategies to stop beta cell destruction early in the disease process.

Proper citation: HIRN Consortium on Beta Cell Death and Survival (RRID:SCR_016198) Copy   

•   Source: SciCrunch Registry

http://sharpentrials.com/

THIS RESOURCE IS OUT OF SERVICE, documented on July 23, 2021.Organization that uses metabolomics to provide pharmaceutical companies with clinically relevant and practical insight into drug response and safety for renal and cardiovascular diseases, obesity and diabetes. Their combination of skills to achieve exhaustive understanding of a disease along with detailed clinical insights, signature panel of urine-based metabolomic biomarkers, proprietary metabolomics and computational expertise will accelerate the speed and success rate of drug development. ClinMet helps drug developers to efficiently transform promising compounds into safe and effective medicines. Their efficacy and toxicity indices enable pharmaceutical companies to make better clinical trial-related decisions and provide an increased understanding of a drug''s mechanism of action.

Proper citation: ClinMet (RRID:SCR_003979) Copy   

•   Source: SciCrunch Registry

http://cellfinder.de/about/ontology/

Structured vocabulary to organize cell-associated data and to place these data in clearly defined semantic relations to other biological facts. It describes cell types, their properties and origin and links this information to other existing ontologies like the Cell Ontology (CL), Foundational Model of Anatomy (FMA), Gene Ontology (GO), Mouse Anatomy and others using the top-level ontology BioTop.

Proper citation: CELDA Ontology (RRID:SCR_001601) Copy   

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http://tvmouse.ucdavis.edu/anatomy/

Access to Quicktime movies of histologic mouse anatomy including heart / lung, kidney, mammary gland, lymph node, prostate, spleen, liver, salivary glands, and 3-D wire model based on MRI sections; a Quicktime mouse radiographic atlas of skeletal anatomy containing a series of radiographic images with color overlays and labels; and a table containing a comparison between mouse and human anatomy. Special topics include the virtual necroscopy. Anatomic systems cover the central nervous system, male genital-urinary tract, female genital-urinary tract, mammary, kidney, skeletal, cardiovascular, gastrointestinal, and respiratory systems. The pathology and imaging section includes anatomy, histology, comparative imaging, physiology, pathology, comparative mammary, comparative prostate, GEM, and an image archive. These pages were put together as a pilot demonstration by Dr. Robert Cardiff, UCD Center for Comparative Medicine with the collaboration of Dr. Michael Paulus, Oak Ridge National Laboratories,MicroCat Group, Dr. Allan Johnson, Duke University Center for In Vivo Microscopy, and Drs. Steve Griffey, Gary Henderson and Tom Jue, University of California, Davis. This is a work in progress and for demonstration purposes.

Proper citation: Visible Mouse Anatomy (RRID:SCR_001603) Copy   

•   Source: SciCrunch Registry

http://www.nih.gov/science/amp/autoimmune.htm

The autoimmune disease arm of the Accelerating Medicine Partnership (AMP), which aims to identify and validate the most promising biological targets of disease for new diagnostic and drug development, that is focused on rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). They seek to identify shared common flaws in inflammation, particularly those that are shared with a larger number of autoimmune disorders which can cause severe disability, greatly affect quality of life, and are associated with an increased risk of death. This project aims to reveal biomarkers and biological targets for drug development, matching existing drugs to patients with specific molecular profiles who are most likely to benefit. The research plan proposes a 5 year process. Year one will include startup activities such as validation of tissue acquisition processes and analytic technologies, and the development of operating procedures. The second year will focus on identification of disease specific pathways by comparing data from patients and healthy individuals. Years 3-5 will expand the scale to include comparisons of different subsets of patients with RA or lupus to allow molecularly based patient stratification for precise treatment. The final 12 months (2019) will also include preliminary target validation. The data will be made publicly available through an internet-based information portal.

Proper citation: Accelerating Medicines Partnership Autoimmune Diseases of Rheumatoid Arthritis and Lupus (RRID:SCR_003731) Copy   

•   Source: SciCrunch Registry

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

A public-private partnership to identify new and improved translational safety testing methods for use in nonclinical and clinical studies and submit them for formal regulatory qualification by the FDA (Food and Drug Administration), EMA (European Medicines Agency), and PMDA (Japanese Pharmaceutical and Medical Devices Agency). The current 19 corporate members of the consortium share internal experience with nonclinical and clinical safety biomarkers in six working groups: cardiac hypertrophy, nephrotoxicity, hepatotoxicity, skeletal myopathy, testicular toxicity, and vascular injury. The ultimate goal of the consortium is to improve the current approach to drug safety testing and offer assurance to the drug developers that these approaches will be accepted by the regulatory authorities in their drug development programs. Through PSTC, members are able to share their expertise, resources, data, and internally developed approaches in a neutral, precompetitive, confidential environment. There are more than 250 participating scientists and C-Path serves as the trusted third party, leading the collaborative process by collecting and summarizing the data, and leading the interactions with global health authorities.

Proper citation: Predictive Safety Testing Consortium (RRID:SCR_003727) Copy   

•   Source: SciCrunch Registry

http://www.renalmd.org/

An association representing and serving nephrology practitioners in the United States whose members are committed to improving the care of patients with chronic kidney disease (CKD) and related disorders. RPA educates policymakers about issues that affect both patients and nephrology practices. They also work with the Centers for Medicare & Medicaid Services (CMS) on regulatory policies. (Adapted from Wikipedia) Programs focus in the areas of practice management, public policy and quality patient care. They provide timely and relevant programs along with current nephrology tools and resources to make certain members maintain their highest level of professional satisfaction.

Proper citation: Renal Physicians Association (RRID:SCR_004048) Copy   

•   Source: SciCrunch Registry

http://www.onestudy.org/

Consortium aiming to produce regulatory T cells that are compatible with a kidney transplant patient''''s immune system, as a measure to suppress the body''''s natural immune response against a transplanted organ. If successful, this approach will reduce a transplantation patient''''s life-long dependency on immune suppressing drugs, many of which are often associated with undesirable side effects and can limit the patient''''s daily routine. The consortium goals are to develop and conduct clinical trials of various immunoregulatory T-cell-based products in organ transplantation recipients, allowing a direct comparison of the safety, clinical practicality and therapeutic efficacy of each cell type. The central focus of the project is to: # Production and manufacture of distinct populations of hematopoietic immunoregulatory T cells # Comparatively study the tolerogenic characteristics of these regulatory cell types # Test these cell therapy products side by side in a clinical trial living donor renal transplant recipients The first workstream will work with different T regulatory cell, tolerogenic DC and suppressive macrophage cell products that are currently in development. In addition to these therapeutics, another goal of this workstream is to develop a cell tracking technology that assesses pharmacodynamics and pharmacokinetics of these cell-based therapies. The second workstream is focused on designing and conducting a cell therapy based clinical trial in renal transplantation, taking into consideration ethics, concurrent immunosuppressive drug use, state-of-the-art immune monitoring, innovative all-in-one data capturing systems, and pharmacovigilance. The goal is to have a comparative evaluation of hematopoietic cell therapy safety in renal transplantation. The third workstream aims to learn more about the specific comparative characteristics of suppressive cell types and to use this knowledge to improve later trial designs and foster novel ideas for new or improved suppressive / tolerogenic cell population.

Proper citation: ONE Study (RRID:SCR_003886) Copy   

•   Source: SciCrunch Registry

http://mmdb.iab.keio.ac.jp/

MMMDB, Mouse Multiple tissue Metabolome DataBase, is a freely available metabolomic database containing a collection of metabolites measured from multiple tissues from single mice. The datases are collected using a single instrument and not integrated from literatures, which is useful for capturing the holistic overview of large metabolomic pathway. Currently data from cerabra, cerebella, thymus, spleen, lung, liver, kidney, heart, pancreas, testis, and plasma are provided. Non-targeted analyses were performed by capillary electropherograms time-of-flight mass spectrometry (CE-TOFMS) and, therefore, both identified metabolites and unknown (without matched standard) peaks were uploaded to this database. Not only quantified concentration but also processed raw data such as electropherogram, mass spectrometry, and annotation (such as isotope and fragment) are provided.

Proper citation: MMMDB - Mouse Multiple tissue Metabolome DataBase (RRID:SCR_006064) Copy   

•   Source: SciCrunch Registry

https://www.phc.ox.ac.uk/research/technology-outputs/oval-calc

Software that allows you to quantify glucose homeostasis in type 2 diabetes and control subjects. OVAL also has the capacity to quantify sequential deterioration and monitor effects of intervention.

Proper citation: OVAL (RRID:SCR_016261) Copy   

•   Source: SciCrunch Registry

http://nmri.niddk.nih.gov/

Communication network of current and potential biomedical research investigators and technical personnel from traditionally under-served communities: African American, Hispanic American, American Indian, Alaskan Native, Native Hawaiian, and other Pacific Islanders. The major objective of the network is to encourage and facilitate participation of members of underrepresented racial and ethnic minority groups in the conduct of biomedical research in the fields of diabetes, endocrinology, metabolism, digestive diseases, nutrition, kidney, urologic and hematologic diseases. A second objective is to encourage and enhance the potential of the underrepresented minority investigators in choosing a biomedical research career in these fields. An important component of this network is promotion of two-way communications between network members and the NIDDK.

Proper citation: Network of Minority Health Research Investigators (RRID:SCR_006589) Copy   

•   Source: SciCrunch Registry

http://cellfinder.de/

Database of mapped validated gene and protein expression, phenotype and images related to cell types. The data allow characterization and comparison of cell types and can be browsed by using the body browser and by searching for cells or genes. All cells are related to more complex systems such as tissues, organs and organisms and arranged according to their position in development. CellFinder provides long-term data storage for validated and curated primary research data and provides additional expert-validation through relevant information extracted from text. Operated under the Open Source/Access model, community and scientific networking applications will allow users to store and retrieve their data and to explore cells and their interactions on singular and complex resolution levels. The involvement of stem cell registries and banks will allow direct access to selected cells. The set up the stem cell data repository will involve three lines of action: * the acquisition of scientific data and contents * the standardized description of this data, its organization with the help of ontologies and technical implementation * the integration of existing sources/logistics and to ensure sustainable long-term operation

Proper citation: CellFinder (RRID:SCR_006598) Copy   

•   Source: SciCrunch Registry

http://www.diabetes.niddk.nih.gov/

Information dissemination service of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) established to increase knowledge and understanding about diabetes among patients, health care professionals, and the general public: online, in booklets and fact sheets, by email, and over the phone. To carry out this mission, NDIC works closely with NIDDK''''s Diabetes Research and Training Centers; the National Diabetes Education Program (NDEP); professional, patient, and voluntary associations; Government agencies; and State health departments to identify and respond to informational needs about diabetes and its management. NDIC provides the following informational products and services: * Response to inquiries about diabetes, ranging from information about available patient and professional education materials to statistical data. By phone (8:30 a.m. to 5 p.m. eastern time, M-F), fax, mail, and email. * Publications about diabetes, provided free of copyright, in varying reading levels. Available online or as booklets and brochures. NDIC also sends publications to health fairs and community events. * Referrals to health professionals through the National Library of Medicine''''s MEDLINEplus includes a consumer-friendly listing of organizations that will assist you in your search for physicians and other health professionals. * Exhibits at professional meetings specific to diabetes, as well as cross-cutting professional meetings. NDIC exhibits at 12 professional meetings, each year, including American Diabetes Association Postgraduate Course, American College of Physicians, CDC Diabetes Translation Conference, American Academy of Physician Assistants, American Diabetes Association, American Association of Diabetes Educators, and American Dietetic Association.

Proper citation: National Diabetes Information Clearinghouse (RRID:SCR_006702) Copy   

•   Source: SciCrunch Registry