Ignite Creation Date:
2025-12-26 @ 12:15 PM
Ignite Modification Date:
2025-12-26 @ 12:15 PM
Study NCT ID:
NCT01209000
Status:
RECRUITING
Last Update Posted:
2025-04-24
First Post:
2010-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nephrotic Syndrome Study Network
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009402', 'term': 'Nephrosis, Lipoid'}, {'id': 'D015433', 'term': 'Glomerulonephritis, Membranous'}, {'id': 'D005923', 'term': 'Glomerulosclerosis, Focal Segmental'}, {'id': 'C537834', 'term': 'Macular dystrophy, corneal type 1'}, {'id': 'D009404', 'term': 'Nephrotic Syndrome'}], 'ancestors': [{'id': 'D009401', 'term': 'Nephrosis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Renal tissue core (from clinically indicated kidney biopsy procedure) Blood products Urine products DNA/RNA specimens (declining consent does not forego participant eligibility)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-18', 'studyFirstSubmitDate': '2010-07-29', 'studyFirstSubmitQcDate': '2010-09-23', 'lastUpdatePostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event rate of change in urinary protein excretion and renal function.', 'timeFrame': '60 months', 'description': 'Defined as remission, partial remission and non-remission'}, {'measure': 'Rate of change in renal function.', 'timeFrame': '60 months', 'description': 'Defined as:\n\n1. 25 mls/min/1.73m2 reduction in follow-up estimated GFR (using the 4-variable MDRD equation for ages ≥18 years and modified Schwartz for ages \\<18 years) compared to baseline estimated GFR\n2. 50% decline in follow-up estimated GFR compared to baseline measurement\n3. End stage renal disease defined as estimated GFR ≤10cc/min, initiation of maintenance dialysis or preemptive kidney transplantation.'}], 'secondaryOutcomes': [{'measure': 'Quality of Life:', 'timeFrame': '60 months', 'description': 'Patient-reported outcome will be assessed using Quality of Life questionnaires at regular intervals as stipulated in the visit calendar using the SF-36, PedsQL and the Patient Reported Outcome Measurement Information System (PROMIS) (in the age-appropriate groups).'}, {'measure': 'Malignancies', 'timeFrame': '60 months', 'description': 'Any cancer diagnosis of the skin, hematopoietic system, or solid organ after enrollment in NEPTUNE'}, {'measure': 'Infections, Serious and Systemic', 'timeFrame': '60 months', 'description': 'Infections including one of the following:\n\n1. Documented diagnosis of infection of the skin or subcutaneous tissue (e.g. cellulitis), vascular system, peritoneum, or any vital organ requiring the use of parenteral antibiotics and/or oral antibiotics alone or in combination for a treatment interval of ≥72 hours.\n2. Hospitalization for treatment of infection'}, {'measure': 'Thromboembolic Events', 'timeFrame': '60 months', 'description': 'Documented diagnosis of one of the following:\n\n1. Embolic cerebrovascular accident\n2. Deep venous thrombosis\n3. Renal vein thrombosis or\n4. Pulmonary embolus'}, {'measure': 'Hospitalization', 'timeFrame': '60 months', 'description': 'Documented hospital admission, including observation for ≥24 hours.'}, {'measure': 'Emergency Department/ Observation Unit Visit', 'timeFrame': '60 months', 'description': 'Documented visit to an emergency department or observation unit that does not lead to hospitalization and is less than 24 hours.'}, {'measure': 'Acute Kidney Injury', 'timeFrame': '60 months', 'description': 'Documented diagnosis of acute kidney injury as defined by the AKIN (Mehta et al., Critical Care 2007, 11:R31) and/or renal failure requiring renal replacement therapy \\<3 months.'}, {'measure': 'Death', 'timeFrame': '60 months', 'description': '1. Documentation of death that is secondary to infection or sepsis.\n2. Cardiovascular/Cerebrovascular-related Death: Sudden death; Myocardial infarction; Congestive heart failure; Primary intractable serious arrhythmia; Peripheral vascular disease; Ischemic cerebrovascular accident; Hemorrhagic cerebrovascular accident; Thromboembolic event\n3. Documentation of death secondary to cancer\n4. Other Death: Documentation of death that does not fall into the above categories.'}, {'measure': 'New Onset Diabetes', 'timeFrame': '60 months', 'description': 'Diagnosis of diabetes as indicated by 1 or more of the following not present at NEPTUNE Enrollment:\n\n1. Documented diagnosis of diabetes in medical record\n2. Casual (non-fasting) blood glucose \\> 200 mg/dL c) Fasting blood glucose \\> 126 mg/dL d) 2 hour glucose \\> 200 after oral glucose tolerance test e) chronic use (\\>6 mos) hypoglycemic therapy outside of pregnancy f) Hemogloblin A1C \\>= 6.5%'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Focal and Segmental Glomerulosclerosis', 'Focal & Segmental Glomerulosclerosis', 'Focal Segmental Glomerulosclerosis', 'FSGS', 'Minimal change disease', 'MCD', 'Membranous Nephropathy', 'MN', 'Nephrotic Syndrome', 'Neph Syndrome', 'NEPTUNE', 'NephCure', 'Halpin'], 'conditions': ['Minimal Change Disease (MCD)', 'Membranous Nephropathy', 'Glomerulosclerosis, Focal Segmental']}, 'referencesModule': {'references': [{'pmid': '34796395', 'type': 'DERIVED', 'citation': 'Wang CS, Troost JP, Wang Y, Greenbaum LA, Gibson K, Trachtman H, Srivastava T, Reidy K, Kaskel F, Sethna CB, Meyers K, Dell KM, Tran CL, Hingorani S, Lemley KV, Lin JJ, Gipson DS. Determinants of medication adherence in childhood nephrotic syndrome and associations of adherence with clinical outcomes. Pediatr Nephrol. 2022 Jul;37(7):1585-1595. doi: 10.1007/s00467-021-05176-8. Epub 2021 Nov 18.'}, {'pmid': '34060483', 'type': 'DERIVED', 'citation': 'Solagna F, Tezze C, Lindenmeyer MT, Lu S, Wu G, Liu S, Zhao Y, Mitchell R, Meyer C, Omairi S, Kilic T, Paolini A, Ritvos O, Pasternack A, Matsakas A, Kylies D, Wiesch JSZ, Turner JE, Wanner N, Nair V, Eichinger F, Menon R, Martin IV, Klinkhammer BM, Hoxha E, Cohen CD, Tharaux PL, Boor P, Ostendorf T, Kretzler M, Sandri M, Kretz O, Puelles VG, Patel K, Huber TB. Pro-cachectic factors link experimental and human chronic kidney disease to skeletal muscle wasting programs. J Clin Invest. 2021 Jun 1;131(11):e135821. doi: 10.1172/JCI135821.'}, {'pmid': '26589142', 'type': 'DERIVED', 'citation': 'Kang H, Kim DR, Jung YH, Baek CW, Park YH, In Oh J, Kim WJ, Choi GJ. Pre-warming the Streamlined Liner of the Pharynx Airway (SLIPA) improves fitting to the laryngeal structure: a randomized, double-blind study. BMC Anesthesiol. 2015 Nov 20;15:167. doi: 10.1186/s12871-015-0151-4.'}, {'pmid': '26577187', 'type': 'DERIVED', 'citation': 'Hogan MC, Lieske JC, Lienczewski CC, Nesbitt LL, Wickman LT, Heyer CM, Harris PC, Ward CJ, Sundsbak JL, Manganelli L, Ju W, Kopp JB, Nelson PJ, Adler SG, Reich HN, Holzmann LB, Kretzler M, Bitzer M. Strategy and rationale for urine collection protocols employed in the NEPTUNE study. BMC Nephrol. 2015 Nov 17;16:190. doi: 10.1186/s12882-015-0185-3.'}], 'seeAlsoLinks': [{'url': 'http://rarediseasesnetwork.org', 'label': 'Rare Diseases Clinical Research Networks Homepage'}, {'url': 'http://www.nephcure.org', 'label': 'Patient Advocacy group for FSGS/MCD'}, {'url': 'http://www.halpinfoundation.org/', 'label': 'Patient advocacy group for MN'}, {'url': 'http://www.neptune-study.org', 'label': 'The NEPTUNE Study Homepage'}]}, 'descriptionModule': {'briefSummary': 'Minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), and Membranous nephropathy (MN), generate an enormous individual and societal financial burden, accounting for approximately 12% of prevalent end stage renal disease (ESRD) cases (2005) at an annual cost in the US of more than $3 billion. However, the clinical classification of these diseases is widely believed to be inadequate by the scientific community. Given the poor understanding of MCD/FSGS and MN biology, it is not surprising that the available therapies are imperfect. The therapies lack a clear biological basis, and as many families have experienced, they are often not beneficial, and in fact may be significantly toxic. Given these observations, it is essential that research be conducted that address these serious obstacles to effectively caring for patients.\n\nIn response to a request for applications by the National Institutes of Health, Office of Rare Diseases (NIH, ORD) for the creation of Rare Disease Clinical Research Consortia, a number of affiliated universities joined together with The NephCure Foundation the NIDDK, the ORDR, and the University of Michigan in collaboration towards the establishment of a Nephrotic Syndrome (NS) Rare Diseases Clinical Research Consortium.\n\nThrough this consortium the investigators hope to understand the fundamental biology of these rare diseases and aim to bank long-term observational data and corresponding biological specimens for researchers to access and further enrich.', 'detailedDescription': 'Idiopathic Nephrotic Syndrome (NS) is a rare disease syndrome responsible for approximately 12% of all causes of end-stage kidney disease (ESRD) and up to 20% of ESRD in children. Treatment strategies for Focal and Segmental Glomerulosclerosis (FSGS), Minimal Change Disease (MCD) and Membranous Nephropathy (MN), the major causes of NS, include high dose prolonged steroid therapy, cyclophosphamide, cyclosporine A, tacrolimus, mycophenolate mofetil and other immunosuppressive agents, which all carry significant side effects. Failure to obtain remission using the current treatment approaches frequently results in progression to ESRD with its associated costs, morbidities, and mortality. In the North American Pediatric Renal Trials and Collaborative Studies (NAPRTCS) registry, half of the pediatric patients with Steroid Resistant Nephrotic Syndrome required renal replacement therapy within two years of being enrolled in the disease registry. FSGS also has a high recurrence rate following kidney transplantation (30-40%) and is the most common recurrent disease leading to allograft loss.\n\nThe prevailing classification of Nephrotic Syndrome categorizes patients into FSGS, MCD, and MN, if in the absence of other underlying causes, glomerular histology shows a specific histological pattern. This classification does not adequately predict the heterogeneous natural history of patients with FSGS, MCD, and MN. Major advances in understanding the pathogenesis of FSGS and MCD have come over the last ten years from the identification of several mutated genes responsible for causing Steroid Resistant Nephrotic Syndrome (SRNS) presenting with FSGS or MCD histopathology in humans and model organisms. These functionally distinct genetic disorders can present with indistinguishable FSGS lesions on histology confirming the presence of heterogeneous pathogenic mechanisms under the current histological diagnoses.\n\nThe limited understanding of FSGS, MCD, and MN biology in humans has necessitated a descriptive classification system in which heterogeneous disorders are grouped together. This invariably consigns these heterogeneous patients to the same therapeutic approaches, which use blunt immunosuppressive drugs that lack a clear biological basis, are often not beneficial, and are complicated by significant toxicity. The foregoing shortcomings make a strong case that concerted and innovative investigational strategies combining basic science, translational, and clinical methods should be employed to study FSGS, MCD, and MN. It is for these reasons that the Nephrotic Syndrome Study Network is established to conduct clinical and translational research in patients with FSGS/MCD and MN.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with signs and symptoms of kidney disease consistent with FSGS, MCD, MN or proteinuric renal disease or pediatric participants not previously biopsied, who present for patient care at participating clinical centers will be eligible for Cohort A (biopsy cohort) study population targeted for enrollment into the NEPTUNE study.\n\nTo establish a cohort of pediatric participants with incident nephrotic syndrome, Cohort B, a non-biopsy cohort has been initiated for Protocol V4.0. This population, \\<19 years of age, presenting for nephrotic syndrome and less than 30 days of immunosuppression therapy exposure, will also be targeted for enrollment into the cNEPTUNE study.\n\nPotential participants willing to receive their initial care and subsequent follow-up study visits at one of these sites are welcome to participate.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Cohort A (biopsy cohort) Inclusion Criteria:\n\nPatients presenting with an incipient clinical diagnosis for FSGS/MCD or MN or pediatric participants not previously biopsied, with a clinical diagnosis for FSGS/MCD or MN meeting the following inclusion criteria:\n\n* Documented urinary protein excretion ≥1500 mg/24 hours or spot protein: creatinine ratio equivalent at the time of diagnosis or within 3 months of the screening/eligibility visit.\n* Scheduled renal biopsy\n\nCohort B (non-biopsy, cNEPTUNE) Inclusion Criteria:\n\n* Age \\<19 years of age\n* Initial presentation with \\<30 days immunosuppression therapy\n* Proteinuria/nephrotic\n\n * UA\\>2+ and edema OR\n * UA\\>2+ and serum albumin \\<3 OR\n * UPC \\> 2g/g and serum albumin \\<3\n\nExclusion Criteria (Cohort A\\&B):\n\n* Prior solid organ transplant\n* A clinical diagnosis of glomerulopathy without diagnostic renal biopsy\n* Clinical, serological or histological evidence of systemic lupus erythematosus (SLE) as defined by the ARA criteria. Patients with membranous in combination with SLE will be excluded because this entity is well defined within the International Society of Nephrology/Renal Pathology Society categories of lupus nephritis, and frequently overlaps with other classification categories of SLE nephritis (68)\n* Clinical or histological evidence of other renal diseases (Alport, Nail Patella, Diabetic Nephropathy, IgA-nephritis, monoclonal gammopathy (multiple myelomas), genito-urinary malformations with vesico-urethral reflux or renal dysplasia)\n* Known systemic disease diagnosis at time of enrollment with a life expectancy less than 6 months\n* Unwillingness or inability to give a comprehensive informed consent\n* Unwillingness to comply with study procedures and visit schedule\n* Institutionalized individuals (e.g., prisoners)'}, 'identificationModule': {'nctId': 'NCT01209000', 'acronym': 'NEPTUNE', 'briefTitle': 'Nephrotic Syndrome Study Network', 'nctIdAliases': ['NCT01240564'], 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Nephrotic Syndrome Study Network Under the Rare Diseases Clinical Research Network', 'orgStudyIdInfo': {'id': '6801'}, 'secondaryIdInfos': [{'id': '1U54DK083912', 'link': 'https://reporter.nih.gov/quickSearch/1U54DK083912', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'FSGS/MCD Cohort (Cohort A)', 'description': 'Focal Segmental Glomerulosclerosis/Minimal Change Disease (FSGS/MCD) Cohort\n\nParticipants enrolled in NEPTUNE with a biopsy proven histological diagnosis for FSGS or MCD.\n\nEligible participants must be scheduled for a clinically indicated renal biopsy.', 'interventionNames': ['Procedure: Kidney Biopsy']}, {'label': 'MN Cohort (Cohort A)', 'description': 'Membranous Nephropathy (MN) Cohort\n\nParticipants enrolled in NEPTUNE with a biopsy proven histological diagnosis for MN.\n\nEligible participants must be scheduled for a clinically indicated renal biopsy.', 'interventionNames': ['Procedure: Kidney Biopsy']}, {'label': 'Other glomerulopathies cohort', 'description': 'Participants enrolled in NEPTUNE and determined to not have FSGS/MCD or MN will be followed in a third group.\n\nEligible participants must be scheduled for a clinically indicated renal biopsy.', 'interventionNames': ['Procedure: Kidney Biopsy']}, {'label': 'cNEPTUNE (Cohort B)', 'description': 'Participants \\< 19 years of age, with \\< 30 days exposure to immunosuppression therapy who are not scheduled for renal biopsy.'}], 'interventions': [{'name': 'Kidney Biopsy', 'type': 'PROCEDURE', 'description': 'Patients scheduled to undergo a clinically indicated kidney biopsy will be requested to consent to an additional renal core, to be set aside until all clinical care is complete.', 'armGroupLabels': ['FSGS/MCD Cohort (Cohort A)', 'MN Cohort (Cohort A)', 'Other glomerulopathies cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90227', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sharon Tang, BSN', 'role': 'CONTACT', 'email': 'shatang@chla.usc.edu', 'phone': '323-361-7299'}, {'name': 'Kevin Lemley, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "University of Southern California-Children's Hospital", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kshama Mehta, PhD', 'role': 'CONTACT', 'email': 'krmehta@stanford.edu', 'phone': '650-736-1822'}, {'name': 'Richard Lafayette, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Daniel Schrader', 'role': 'CONTACT', 'email': 'daniel.schrader@ucsf.edu'}, {'name': 'Paul Brakeman, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "University of California San Francisco Benioff Children's Hospitals", 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Janine LaPage', 'role': 'CONTACT', 'email': 'jlapage@labiomed.org', 'phone': '310-222-4104'}, {'name': 'Sharon Adler, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lundquist Biomedical Research Institute at Harbor UCLA Medical Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nathan Rogers', 'role': 'CONTACT', 'email': 'Nathan.Rogers@childrenscolorado.org'}, {'name': 'Gabriel Cara-Fuentes, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elizabeth Wagner', 'role': 'CONTACT', 'email': 'elizabeth.c.wagner@cuanschutz.edu'}, {'name': 'Amber Podoll, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Colorado Anschutz School of Medicine', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Carlos Bidot', 'role': 'CONTACT', 'email': 'cbidot2@miami.edu', 'phone': '305-243-8973'}, {'name': 'Alessia Fornoni, MD. PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Miami Miller School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emily Yun', 'role': 'CONTACT', 'email': 'emily.yun@emory.edu', 'phone': '404-712-9998'}, {'name': 'Laurence Greenbaum, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Emory University and Children's Healthcare of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60680', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mathew Itteera', 'role': 'CONTACT', 'email': 'mitteera@cookcountyhhs.org', 'phone': '312-864-4614'}, {'name': 'Ambarish Athavale, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'John Stroger Cook County Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Catherine Creed', 'role': 'CONTACT', 'email': 'ccreed@kumc.edu'}, {'name': 'Ellen McCarthy, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sara Boynton', 'role': 'CONTACT', 'email': 'sboynto3@jhmi.edu', 'phone': '443-287-9051'}, {'name': 'Alicia Neu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Michael Choi, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Johns Hopkins Medical Institute', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Kidney Disease Section, NIDDK, NIH', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hailey Desmond, MS', 'role': 'CONTACT', 'email': 'heturner@umich.edu', 'phone': '734-232-4851'}, {'name': 'Debbie Gipson, MD, MS', 'role': 'SUB_INVESTIGATOR'}], 'facility': "CS Mott Children's Hospital, University of Michigan", 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chrysta C. Lienczewski, BS - adult', 'role': 'CONTACT', 'email': 'boridley@med.umich.edu', 'phone': '734-615-5021'}, {'name': 'Amanda Williams, BS - adult', 'role': 'CONTACT', 'email': 'amwi@umich.edu', 'phone': '734-615-5017'}, {'name': 'Matthias Kretzler, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Michigan Medical Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kelsey Markus', 'role': 'CONTACT', 'email': 'kemarkus@cmh.edu'}, {'name': 'Tarak Srivastava, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Leslie Walther', 'role': 'CONTACT', 'email': 'leslie.walther@wustl.edu'}, {'name': 'Vikas Dharnidharka, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Washington University - St Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Suzanne Vento, BSN', 'role': 'CONTACT', 'email': 'svento@northwell.edu', 'phone': '718-470-3499'}, {'name': 'Christine Sethna, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Cohen Children's Hospital", 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': '10010', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Frank Modersitzki, MPH - adult', 'role': 'CONTACT', 'email': 'Frank.Modersitzki@va.gov', 'phone': '212-686-7500', 'phoneExt': '6379'}, {'name': 'Laura Jane Pehrson - peds', 'role': 'CONTACT', 'email': 'laurajane.pehrson@nyulangone.org'}, {'name': 'Olga Zhadnova, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Howard Trachtman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'New York University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Frank Modersitzki, MPH', 'role': 'CONTACT', 'email': 'Frank.Modersitzki@va.gov', 'phone': '212-686-7500', 'phoneExt': '6379'}, {'name': 'Laura Barisoni, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Olga Zhadnova, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Bellevue Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Frank Modersitzki, MPH', 'role': 'CONTACT', 'email': 'Frank.Modersitzki@va.gov', 'phone': '212-686-7500', 'phoneExt': '6379'}, {'name': 'Laura Barisoni, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Olga Zhadnova, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'New York University Veterans Administration', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anup Pradhan', 'role': 'CONTACT', 'email': 'arp2209@cumc.columbia.edu', 'phone': '212-305-6842'}, {'name': 'Andrew Bomback, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11040', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Patti Flynn, RN', 'role': 'CONTACT', 'email': 'pflynn@montefiore.org', 'phone': '718-655-1120'}, {'name': 'Frederick Kaskel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Robert Woroniecki, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anne Froment', 'role': 'CONTACT', 'email': 'Anne_Froment@med.unc.edu', 'phone': '919-923-1382'}, {'name': 'Fernanda Ochoa', 'role': 'CONTACT', 'email': 'ferochoa@email.unc.edu'}, {'name': 'Patrick H. Nachman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Susan L. Hogan, PhD, MPH', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Keisha Gibson, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Layla Lo', 'role': 'CONTACT', 'email': 'nkauj.lo@atriumhealth.org'}, {'name': 'Susan Massengill, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Atrium Health Levine Children's Hospital", 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Wake Forest School of Medicine', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'COMPLETED', 'country': 'United States', 'facility': "University Hospital Rainbow Babies & Children's Hospital", 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'MetroHealth Hospital at Case Western Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stefanie Larson', 'role': 'CONTACT', 'email': 'larsons2@ccf.org'}, {'name': 'Villarreal', 'role': 'CONTACT'}, {'name': 'Katherine Dell, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alexander Price', 'role': 'CONTACT', 'email': 'alexander.price2@osumc.edu'}, {'name': 'Salem Almaani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Ohio State University Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alilya Edwards', 'role': 'CONTACT', 'email': 'EdwardsA1@chop.edu'}, {'name': 'Kevin Meyers, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Krishna Kallem, MD - adult, MS', 'role': 'CONTACT', 'email': 'krishna.kallem@uphs.upenn.edu', 'phone': '484-358-0315'}, {'name': 'Aliya Edwards - peds', 'role': 'CONTACT', 'email': 'EdwardsA1@chop.edu'}, {'name': 'Lawrence Holzman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Zoe Pfeffer, BS', 'role': 'CONTACT', 'email': 'zoe.pfeffer@tuhs.temple.edu', 'phone': '215-707-4712'}, {'name': 'Crystal Gadegbeku, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Iris Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Temple University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Selewski, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elizabeth Robles', 'role': 'CONTACT', 'email': 'elizabeth.robles@utsouthwestern.edu'}, {'name': 'Kamal Sambandam, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Texas-Southwestern', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aisha Deslandes', 'role': 'CONTACT', 'email': 'aisha.deslandes@bcm.edu'}, {'name': 'Shweta S. Shah, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Texas Children's Hospital - Baylor College of Medicine", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98145', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emily Pao', 'role': 'CONTACT', 'email': 'emily.pao@seattlechildrens.org'}, {'name': 'Sangeeta Hingorani, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Linda Manahan, BSN', 'role': 'CONTACT', 'email': 'lmanahan@nephrology.washington.edu'}, {'name': 'Peter J. Nelson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ann Cooper, CCRC', 'role': 'CONTACT', 'email': 'Ann.Cooper@providence.org', 'phone': '509-474-4327'}, {'name': 'Kelli Kuykendall, CCRC', 'role': 'CONTACT', 'email': 'Kelli.Kuykendall@providence.org', 'phone': '509-474-4320'}, {'name': 'Katherine Tuttle, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Providence Medical Research Center', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': 'L4C 4Z3', 'city': 'Richmond Hill', 'state': 'Ontario', 'status': 'COMPLETED', 'country': 'Canada', 'facility': 'York Central Hospital', 'geoPoint': {'lat': 43.87111, 'lon': -79.43725}}, {'zip': 'M1H 3G4', 'city': 'Scarborough Village', 'state': 'Ontario', 'status': 'COMPLETED', 'country': 'Canada', 'facility': 'Scarborough Hospital', 'geoPoint': {'lat': 43.73899, 'lon': -79.22124}}, {'zip': 'L5M 2N1', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Martin Romano, MD', 'role': 'CONTACT', 'email': 'martin.romano@thp.ca', 'phone': '416-340-3514'}, {'name': 'Phillip Boll, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Credit Valley Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': "Rhea O'Neill", 'role': 'CONTACT', 'email': 'rhea.oneill@sri.utoronto.ca'}, {'name': 'Michelle Hladunewich, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sunnybrook Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G2C4', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Paul Ling, MD', 'role': 'CONTACT', 'email': 'pling@uhnresearch.ca', 'phone': '416-340-3514'}, {'name': 'Martin Romano, MD', 'role': 'CONTACT', 'email': 'Martin.Romano@trilliumhealthpartners.ca'}, {'name': 'Daniel Cattran, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Heather Reich, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Michelle Hladunewich, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Chrysta C. Lienczewski, BS', 'role': 'CONTACT', 'email': 'NEPTUNE-Study@umich.edu', 'phone': '734-615-5021'}, {'name': 'Amanda Williams, BS', 'role': 'CONTACT', 'email': 'NEPTUNE-Study@umich.edu', 'phone': '734-615-5017'}], 'overallOfficials': [{'name': 'Matthias Kretzler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': 'The NephCure Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Matthias Kretzler', 'investigatorAffiliation': 'University of Michigan'}}}}