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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
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
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
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
A not-for-profit research organization committed to improve patient care through research that shapes medical policies and practice. In particular, they conduct health outcomes research on chronic disease and end-stage organ failure, with expertise in biostatistical analysis, clinical practice, health economics, public policy, database management and integration, and project coordination. Through research projects that are national and global in scope, their scientific collaborations provide valuable and timely information to the worldwide health care community. They are a leader in interdisciplinary health outcomes and policy research focused on reducing the health and economic burden of chronic diseases and improving the delivery of care.
Proper citation: Arbor Research Collaborative for Health (RRID:SCR_003972) Copy
Non-profit professional association that represents nurses who work in all areas of nephrology including hemodialysis, chronic kidney disease, peritoneal dialysis, acute care, and transplantation. Most members work in freestanding dialysis units, hospital outpatient units, and hospital inpatient units. ANNA develops and updates standards of clinical practice, educates practitioners, stimulates and supports research, disseminates knowledge and new ideas, promotes interdisciplinary communication and cooperation, and monitors and addresses issues encompassing the breadth of practice of nephrology nursing.
Proper citation: American Nephrology Nurses Association (RRID:SCR_003966) Copy
THIS RESOURCE IS NO LONGER IN SERVICE; REPLACED BY NEPHROSEQ; A growing database of publicly available renal gene expression profiles, a sophisticated analysis engine, and a powerful web application designed for data mining and visualization of gene expression. It provides unique access to datasets from the Personalized Molecular Nephrology Research Laboratory incorporating clinical data which is often difficult to collect from public sources and mouse data.
Proper citation: Nephromine (RRID:SCR_003813) Copy
http://www.nkdep.nih.gov/lab-evaluation/gfr/creatinine-standardization.shtml
Standard specification to reduce inter-laboratory variation in creatinine assay calibration and therefore enable more accurate estimates of glomerular filtration rate (eGFR). Created by NKDEP''''s Laboratory Working Group in collaboration with the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the European Communities Confederation of Clinical Chemistry (now called the European Federation of Clinical Chemistry and Laboratory Medicine), the effort is part of a larger NKDEP initiative to help health care providers better identify and treat chronic kidney disease in order to prevent or delay kidney failure and improve patient outcomes. Recommendations are intended for the USA and other countries or regions that have largely completed standardization of creatinine calibration to be traceable to an isotope dilution mass spectrometry (IDMS) reference measurement procedure. The program''''s focus is to facilitate the sharing of information to assist in vitro diagnostic manufacturers, clinical laboratories, and others in the laboratory community with calibrating their serum creatinine measurement procedures to be traceable to isotope dilution mass spectrometry (IDMS). The program also supports manufacturers'''' efforts to encourage their customers in the laboratory to coordinate use of standardized creatinine methods with implementation of a revised GFR estimating equation appropriate for use with standardized creatinine methods. Communication resources and other information for various segments of the laboratory community are available in the Creatinine Standardization Recommendations section of the website. Also available is a protocol for calibrating creatinine measurements using whole blood devices. The National Institute for Standards and Technology (NIST) released a standard reference material (SRM 967 Creatinine in Frozen Human Serum) for use in establishing calibrations for routine creatinine measurement procedures. SRM 967 was validated to be commutable with native serum samples for many routine creatinine procedures and is useful to establish or verify traceability to an IDMS reference measurement procedure. Establishing calibrations for serum creatinine methods using SRM 967 not only provides a mechanism for ensuring more accurate measurement of serum creatinine, but also enables more accurate estimates of GFR. For clinical laboratories interested in independently checking the calibration supplied by their creatinine reagent suppliers/manufacturers, periodic measurement of NIST SRM 967 should be considered for inclusion in the lab''''s internal quality assurance program. To learn more about SRM 967, including how to purchase it, visit the NIST website, https://www-s.nist.gov/srmors/quickSearch.cfm
Proper citation: Creatinine Standardization Program (RRID:SCR_006441) Copy
http://www.niaid.nih.gov/topics/transplant/research/Pages/fundedBasics.aspx#NHPTCSP
Cooperative program for research on nonhuman primate models of kidney, islet, heart, and lung transplantation evaluating the safety and efficacy of existing and new treatment regimens that promote the immune system''''s acceptance of a transplant and to understand why the immune system either rejects or does not reject a transplant. This program bridges the critical gap between small-animal research and human clinical trials. The program supports research into the immunological mechanisms of tolerance induction and development of surrogate markers for the induction, maintenance, and loss of tolerance.
Proper citation: Nonhuman Primate Transplantation Tolerance Cooperative Study Group (RRID:SCR_006847) Copy
An association of European kidney specialists whose objective is advancement of medical science and of clinical work in nephrology, dialysis, renal transplantation, hypertension and related subjects. They aim at providing up-to-date knowledge, exclusively based on scientific data, independent from governments'' policies and from any influence of the industry. It is registered in England and Wales, but its area of activity mainly covers Europe and the Mediterranean area.
Proper citation: ERA-EDTA (RRID:SCR_003982) Copy
Multicenter observational study designed to identify genetic determinants of diabetic nephropathy. It is conducted in eleven U.S. clinical centers and a coordinating center, and with four ethnic groups (European Americans, African Americans, Mexican Americans, and American Indians). Two strategies are used to localize susceptibility genes: a family-based linkage study and a case-control study using mapping by admixture linkage disequilibrium (MALD). In the family-based study, probands with diabetic nephropathy are recruited with their parents and selected siblings. Linkage analyses will be conducted to identify chromosomal regions containing genes that influence the development of diabetic nephropathy or related quantitative traits such as serum creatinine concentration, urinary albumin excretion, and plasma glucose concentrations. Regions showing evidence of linkage will be examined further with both genetic linkage and association studies to identify genes that influence diabetic nephropathy or related traits. Two types of MALD studies are being done. One is a case-control study of unrelated individuals of Mexican American heritage in which both cases and controls have diabetes, but only the case has nephropathy. The other is a case-control study of African American patients with nephropathy (cases) and their spouses (controls) unaffected by diabetes and nephropathy; offspring are genotyped when available to provide haplotype data. The specific goals of this program: * Delineate genomic regions associated with the development and progression of renal disease(s) * Evaluate whether there is a genetic link between diabetic nephropathy and diabetic retinopathy * Improve outcomes * Provide protection for people at risk and slow the progression of renal disease * Help establish a resource for genetic studies of kidney disease and diabetic complications by creating a repository of genetic samples and a database * Encourage studies of the genetics of progressive renal disease
Proper citation: Family Investigation of Nephropathy of Diabetes (RRID:SCR_001525) Copy
https://sites.cscc.unc.edu/cscc/projects/RIVUR%20
Multicenter, randomized, double-blind, placebo-controlled trial is designed to determine whether daily antimicrobial prophylaxis is superior to placebo in preventing recurrence of urinary tract infection (UTI) in children with vesicoureteral reflux (VUR). The basic eligibility criteria are: (1) age at randomization of at least 2 months, but less than 6 years, (2) a diagnosed first febrile or symptomatic UTI within 42 days prior to randomization that was appropriately treated, and (3) presence of Grade I-IV VUR based on voiding cystourethrogram (VCUG). Patients will be randomly assigned to treatment for 2 years with daily antimicrobial prophylaxis (trimethoprim-sulfamethoxazole) or placebo. The study is designed to recruit 600 children (approximately 300 in each treatment group) over an 18-24 month period. The primary endpoint is recurrence of UTI. In addition, patients will be evaluated for secondary endpoints related to renal scarring and antimicrobial resistance. Scarring will be determined based on renal scintigraphy by 99mTc dimercaptosuccinic (DMSA) scan. Quality of life, compliance, safety parameters, utilization of health resources, and change in VUR will be assessed periodically throughout the study.
Proper citation: RiVuR (RRID:SCR_001539) Copy
http://c-path.org/programs/cfast/
Consortium establishing data standards, tools and methods for conducting research in therapeutic areas important to public health including Alzheimer's disease, Parkinson's disease, multiple sclerosis, polycystic kidney disease, and tuberculosis.CDISC and C-Path have agreed to discontinue using separate CFAST brand, but they both remain committed to this mission and continue to partner to develop and publish therapeutic area data standards.
Proper citation: Coalition For Accelerating Standards and Therapies (RRID:SCR_000206) Copy
http://diabetes.niddk.nih.gov/dm/pubs/america/
A compilation and assessment of epidemiologic, public health, and clinical data on diabetes and its complications in the United States. Published by the National Diabetes Data Group of the National Institute of Diabetes and Digestive and Kidney Diseases, the book contains 36 chapters organized in five areas: * the descriptive epidemiology of diabetes in the United States based on national surveys and community-based studies, including prevalence, incidence, sociodemographic and metabolic characteristics, risk factors for developing diabetes, and mortality * the myriad complications that affect patients with diabetes * characteristics of therapy and medical care for diabetes * economic aspects, including health insurance and health care costs * diabetes in special populations, including African Americans, Hispanics, Asian and Pacific Islanders, Native Americans, and pregnant women. Diabetes in America, 2nd Edition, has been designed to serve as a reliable scientific resource for assessing the scope and impact of diabetes and its complications, determining health policy and priorities in diabetes, and identifying areas of need in research. The intended audience includes health policy makers at the local and Federal levels who need a sound quantitative base of knowledge to use in decision making; clinicians who need to know the probability that their patients will develop diabetes and the prognosis of the disease for complications and premature mortality; persons with diabetes and their families who need sound information on which to make decisions about their life with diabetes; and the research community which needs to identify areas where important scientific knowledge is lacking.
Proper citation: Diabetes in America (RRID:SCR_006754) Copy
World's open biospecimen research database where biobanks and biomedical researchers meet to exchange human biospecimen needs and supply: whole blood, serum, plasma, solid tissue samples and more. The connection is accelerated so researchers save valuable time and money and tissue banks utilize inventory. The pace of specimen procurement remains unacceptably slow to the biomedical research community. Specimen Central is the foremost global resource to aid biomedical researchers in expediting their search for high quality human biospecimens, tissues, samples and specimens. They facilitate your search for blood, whole blood, buccal swab, DNA, RNA, protein, cell lines, plasma, serum, RBC, white cells, buffy coat, fluid, marrow, urine, stem cells, and solid tissue such as tumor, tumor and biopsy materials spanning all manner of common and rare pathologies and indications including Alzheimer's, basal cell carcinoma, bladder cancer, bone cancer, brain cancer, breast cancer, cerebrospinal fluid, amniotic fluid, colorectal cancer, colon cancer, hodgkins and non-hodgkins lymphoma, kidney/renal cancer, leukemia, liver cancer, lung cancer, melanoma, multiple sclerosis, myeloma neuroblastoma, neurodegenerative diseases, ovarian cancer, pancreatic cancer, prostate cancer, urinary cancer. This includes adult and pediatric indications. Specimen Central users specify a number of variables in their Specimen Requests, including preparation, preservation and handling requirements such as cryo-preserved, FFPE (Formalin-fixed paraffin-embedded), formalin, frozen, refrigerated, OCT, snap frozen, paraffin block, fresh, prospective, autopsy or cadaveric, etc. Many users require clinically annotated date associated with their specimens, as well as documentation of IRB or ethics committee approval and informed consents. For Researchers Most specimen databases require researchers to waste time and effort entering lengthy registrations and search queries that yield poor results, if anything. Specimen Central solves this problem by having tissue banks search for you. From years to months, months to weeks, and weeks to days, Specimen Central seeks to reduce delays and costs in the research & development life cycle by expediting connections between demand and supply. For Biobanks The capital costs of maintaining a biobank infrastructure are substantial and growing. Biobanks use Specimen Central as a marketing tool to augment their business development efforts. By routinely checking Specimen Central's Specimen Requests, biobanks can uncover market demand for their inventories and develop new connections and revenue streams to defray costs. Specimen Central supplements - not displaces - the efforts of your sales representatives, agents, brokers and commercial partners.
Proper citation: SpecimenCentral.com (RRID:SCR_003536) Copy
http://www.t1diabetes.nih.gov/T1D-PTP/
THIS RESOURCE IS NO LONGER IN SERVICE, documented August 22, 2016. Investigator access is provided to the established facilities and expertise needed to extend, enhance and validate preclinical studies of promising new therapeutics in cases where additional preclinical testing is needed to validate potential therapies under disease-specific conditions and in multiple animal models before therapeutics can enter the Type 1 Diabetes Rapid Access to Intervention Development (T1D-RAID) development pipeline. The T1D-RAID program provides resources for pre-clinical development of drugs, natural products, and biologics that will be tested as new therapeutics in type 1 diabetes clinical trials. The T1D-RAID program is not currently accepting applications. The T1D-PTP program currently supports two contracts, which are separate from each other and from the T1D-RAID NCI contract resources, to assist in preclinical development of therapeutics for T1D: * Agents to be tested for Preclinical Efficacy in Prevention or Reversal of Type 1 Diabetes in Rodent Models. Type 1 Diabetes Preclinical Testing Program (T1D-PTP) (NOT-DK-09-006) * Needs for Preclinical Efficacy Testing of Promising Agents to Prevent or Reverse Diabetic Complications (NOT-DK-09-009) The T1D-RAID and T1D-PTP are programs intended to remove the most common barriers to progress in identification and development of new therapies for Type 1 Diabetes. The common goal of these programs is to support and provide for the preclinical work necessary to obtain proof of principle establishing that a new molecule or novel approach will be a viable candidate for expanded clinical evaluation.
Proper citation: Type 1 Diabetes Preclinical Testing Program (RRID:SCR_006861) Copy
http://archives.niddk.nih.gov/patient/mist/mist.aspx
Randomized clinical trial to determine the efficacy and safety of three treatments for benign prostatic hyperplasia (BPH): transurethral needle ablation (TUNA), transurethral microwave therapy (TUMT), and medical therapy with alfuzosin and finasteride. The study has been terminated. (Inability to recruit required sample size.)
Proper citation: Minimally Invasive Surgical Therapies Treatment Consortium for Benign Prostatic Hyperplasia (RRID:SCR_007126) Copy
A biopharmaceutical company focused exclusively on discovering, developing and commercializing orally-administered therapeutics to treat autoimmune diseases, inflammatory disorders and cancer. Each drug candidate is a small molecule designed to target a specific chemokine or chemo-attractant receptor, thereby blocking the inflammatory response driven by that particular chemokine while leaving the rest of the immune system unaffected., THIS RESOURCE IS NO LONGER IN SERVICE. Documented on September 16,2025.
Proper citation: ChemoCentryx (RRID:SCR_003976) Copy
A multinational developer, manufacturer, and marketer of medical technologies specializing in the manufacture of vascular, urology, oncology and surgical specialty products. BARD pioneered the development of single-patient-use medical products for hospital procedures; today BARD is dedicated to pursuing technological innovations that offer superior clinical benefits while helping to reduce overall costs. Bard is perhaps best known for having introduced the Foley catheter. (Adapted from Wikipedia)
Proper citation: C. R. Bard (RRID:SCR_003975) Copy
A nonprofit organization made up of a diverse community of healthcare technology professionals that support the healthcare community in the development, management, and use of safe and effective medical technology. It is the primary source of consensus and timely information on medical instrumentation and technology. * AAMI is the primary resource for the industry, the professions, and government for national and international standards. * AAMI provides multidisciplinary leadership and programs that enhance the ability of the professions, healthcare institutions, and industry to understand, develop, manage, and use medical instrumentation and related technologies safely and effectively. * AAMI helps members: contain costs, keep informed of new technology and policy developments, add value in healthcare organizations, and improve professional skills and enhance patient care. * AAMI provides a unique and critical forum for members who cover a complete range of interests, from clinical and biomedical engineers and technicians, physicians, nurses, and hospital administrators, to educators and researchers, manufacturers, distributors, government representatives and other healthcare professionals with an interest in medical devices. * AAMI fulfills its mission through: ** continuing education, conferences ** certification of healthcare technical specialists ** the publication of technical documents, periodicals, books, software.
Proper citation: Association for the Advancement of Medical Instrumentation (RRID:SCR_003973) Copy
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