[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT01016613":3,"trial-entities:NCT01016613":126,"trial-summary:NCT01016613":133},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":27,"primary_purpose":16,"phases":28,"enrollment_info":29,"interventions":32,"primary_outcomes":33,"secondary_outcomes":34,"sex":35,"minimum_age":16,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":36,"std_ages":49,"locations":53,"central_contacts":109,"overall_officials":115,"references":124,"see_also_links":125},"NCT01016613","P30DK081943","Clinical Phenotyping Resource and Biobank Core of the Michigan O'Brien Renal Center","RECRUITING","2030-07","2024-10","2024-10-04","2009-01","University of Michigan","OTHER",true,"Chronic kidney disease (CKD) affects approximately 26 million Americans and disproportionately manifests in specific race and ethnic groups. Patients burdened with CKD have significant morbidity and reduced life expectancy. In addition to excessive suffering and lost productivity, the cost of managing this epidemic has reached $40 billion annually. The recognition that CKD is a major public health problem is reflected in the fourteen objectives outlined in Healthy People 2020 to begin to address the disease burden. Advancement in approaches to halt CKD progression has been slow despite growing global awareness of disease burden.\n\nThis O'Brien Kidney Research Core will create opportunities for novel insights through characterization of tissue profiles that will define new disease markers and molecular pathways and will be available to all kidney investigators on the www. It will thereby fundamentally alter the starting point for research into prevention of progression of these kidney diseases. C-PROBE is an essential element of the center grant and presents a biomedical resource core consisting of: (1) clinical phenotyping (that is, systematic identification of observable physical and biomedical characteristics) of kidney disease patients including the accurate measurement of kidney function; and (2) a specimen BioBank which will store blood, urine and kidney tissue samples. A key component of C-PROBE is therefore that it contains a proven mechanism to collect samples from high risk groups including minorities, at the institutions of University of Michigan Health System, St. John Hospital, Wayne State University in Michigan, John H. Stroger Hospital in Illinois, Temple University Health System in Pennsylvania, and Levine Children's Hospital in North Carolina. This mechanism will feed the other Cores and provide biomedical investigators with approved projects the access to a dynamic pool of well characterized high risk kidney disease patients and their biological specimens to conduct high caliber translational research.",null,[18,19],"Chronic Kidney Disease","Glomerulopathy",[21,22,23,24,25,26],"chronic kidney disease","glomerulonephritis","proteinuria","nephrotic syndrome","nephropathy","biobank","OBSERVATIONAL",[],{"count":30,"type":31},1800,"ESTIMATED",[],[],[],"ALL",{"inclusion":37,"exclusion":40,"raw_text":48},[38,39],"persons of any age who have chronic kidney disease (abnormally high protein in urine or reduced kidney function determined by blood tests)","a small number of people without chronic kidney disease",[41,42,43,44,45,46,47],"people on hemodialysis or peritoneal dialysis","people who have had a kidney transplant","people unable or unwilling to provide consent","women who are pregnant or nursing","adults who have polycystic kidney disease","institutionalized persons","people currently participating in a blinded interventional clinical trial","Inclusion Criteria:\n\n* persons of any age who have chronic kidney disease (abnormally high protein in urine or reduced kidney function determined by blood tests)\n* a small number of people without chronic kidney disease\n\nExclusion Criteria:\n\n* people on hemodialysis or peritoneal dialysis\n* people who have had a kidney transplant\n* people unable or unwilling to provide consent\n* women who are pregnant or nursing\n* adults who have polycystic kidney disease\n* institutionalized persons\n* people currently participating in a blinded interventional clinical trial",[50,51,52],"CHILD","ADULT","OLDER_ADULT",[54,81,89,93,101],{"facility":55,"status":7,"city":56,"state":57,"zip":58,"country":59,"contacts":60,"geoPoint":78},"University of Michigan Health System","Ann Arbor","Michigan","48109","United States",[61,66,70,73,76],{"name":62,"role":63,"phone":64,"email":65},"Chrysta Lienczewski","CONTACT","734-615-5021","boridly@med.umich.edu",{"name":67,"role":63,"phone":68,"email":69},"Sana Shaikh, MD","734-736-4273","skazi@med.umich.edu",{"name":71,"role":72},"Subramaniam Pennathur, MBBS","PRINCIPAL_INVESTIGATOR",{"name":74,"role":75},"Markus Bitzer, MD","SUB_INVESTIGATOR",{"name":77,"role":75},"Matthias Kretzler, MD",{"lat":79,"lon":80},42.27756,-83.74088,{"facility":82,"status":83,"city":84,"state":57,"zip":85,"country":59,"geoPoint":86},"Wayne State University","COMPLETED","Detroit","48201",{"lat":87,"lon":88},42.33143,-83.04575,{"facility":90,"status":83,"city":84,"state":57,"zip":91,"country":59,"geoPoint":92},"St. John's Health System","48236",{"lat":87,"lon":88},{"facility":94,"status":83,"city":95,"state":96,"zip":97,"country":59,"geoPoint":98},"Levine Children's Hospital","Charlotte","North Carolina","28207",{"lat":99,"lon":100},35.22709,-80.84313,{"facility":102,"status":83,"city":103,"state":104,"zip":105,"country":59,"geoPoint":106},"Temple University","Philadelphia","Pennsylvania","19140",{"lat":107,"lon":108},39.95238,-75.16362,[110,112],{"name":62,"role":63,"phone":64,"email":111},"boridley@med.umich.edu",{"name":74,"role":63,"phone":113,"email":114},"734-763-4688","markusbi@med.umich.edu",[116,118,122,123],{"name":117,"affiliation":12,"role":72},"Subramanium Pennathur, MBBS",{"name":119,"affiliation":120,"role":121},"Crystal A Gadegbeku, MD","The Cleveland Clinic","STUDY_DIRECTOR",{"name":77,"affiliation":12,"role":121},{"name":74,"affiliation":12,"role":121},[],[],{"nct_id":4,"conditions":127,"biomarkers":132},[18,128,19,129,130,131],"Glomerulonephritis","Nephropathy","Nephrotic Syndrome","Proteinuria",[],{"nct_id":4,"found":14,"summary":134,"prompt_version":144},{"design":135,"status":136,"heading":137,"summary":138,"follow_up":139,"word_count":140,"commitments":141,"compensation":142,"drugs_mentioned":143},"This is an observational study, meaning researchers will collect information without giving any specific treatments. It plans to include 1800 participants.","completed","Observational Study for Chronic Kidney Disease","This is an observational study looking at chronic kidney disease (CKD) and glomerulopathy. Researchers want to understand more about CKD, which affects many Americans and can lead to serious health problems. They are studying people of all ages who have CKD, which means they have abnormally high protein in their urine or reduced kidney function. A small number of people without CKD can also join. You cannot participate if you are on dialysis, have had a kidney transplant, or are unable to provide consent. The study aims to enroll 1800 participants. The current recruitment status is unclear.","Not specified.",97,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]