KOrea Renal Biobank NEtwoRk System TOward NExt-generation Analysis

Study Overview
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Brief Summary
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Glomerulonephritis (GN) generates an enormous individual and social economic burden. However, the therapeutic options are largely based on clinical and pathological parameters and the individual response to therapy or prognosis is uncertain. Recently, along with advances in molecular analysis and computational bioinformatics, genomic data from human renal biopsies could provide a strong foundation for the future of precision medicine in nephrology. In response to a request for applications by the Ministry of Health and Welfare of Korea for the creation of Clinical Research Registry, multi-center N network has been established for prospective cohort with kidney biopsy samples (KORNERSTONE). Through this Network the investigators hope to understand the fundamental biology of glomerulonephritis and aim to bank long-term observational data and corresponding biological data including genomic data from kidney tissues, and kidney pathologic data which is digitalized This database is archived to a web-based platform to access easily and further enrich for researchers.

Detailed Description
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Glomerulonephritis (GN) such as Minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), Membranous nephropathy (MN), and Immunoglobulin A nephropathy (IgAN) has quite a common clinical presentation often results in renal insufficiency which generates an enormous individual and social economic burden. However, the therapeutic options are largely based on clinical and pathological parameters and the individual response to therapy or prognosis is uncertain. Recently, along with advances in molecular analysis and computational bioinformatics, genomic data from human renal biopsies could provide a strong foundation for the future of precision medicine in nephrology. In response to a request for applications by the Ministry of Health and Welfare of Korea for the creation of Clinical Research Registry, a number of universities joined together to establish Korean Kidney Biopsy Network (KORNERSTONE). Through this Network the investigators hope to understand the fundamental biology of glomerulonephritis and aim to bank long-term observational data and corresponding biological data including genomic data from kidney tissues, and kidney pathologic data which is digitalized This database is archived to a web-based platform to access easily and further enrich for researchers. ============ <Patient clinical data will be collected as follows> Blood tests: CBC, Chemistry (Ca, P, Glucose, Total protein, Albumin, Uric acid), Electrolyte, Renal function (BUN, Creatinine, eGFR), Liver function (AST, ALT) Immunologic blood tests: Complement 3, Complement 4, ASO, RF, Cryoglobulin, dsDNA, ANA Urine tests: Urinalysis, Urine protein, Urine albumin, Urine creatinine Radiologic tests: Kidney USG, Abdominal-pelvis computed tomography Pathologic results Treatment informations: treatment status, drug type, treatment duration Quality of life questionnaire: Kidney Disease and Quality of Life Short Form survey (adults), PedsQL 4.0 Generic Core Scales (pediatrics) Dietary questionnaire

Official Title
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Multicenter Prospective Cohort of Kidney Biopsy for Glomerular Disease Research

Conditions
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Glomerular Disease, Minimal Change Disease, IgA Nephropathy, Membranous Nephropathy, Focal Segmental Glomerulosclerosis, Lupus Nephritis, Crescentic Glomerulonephritis

Intervention / Treatment
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* Other: Kidney Biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Patient suspected of glomerular disease who received kidney biopsy in participating university medical centers Children (age<18 years) also included Exclusion criteria - Patients who previously received a kidney transplant
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| KORNERSTONE<br>Glomerulonephritis (GN) such as Minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), Membranous nephropathy (MN), and Immunoglobulin A nephropathy (IgAN) Participants enrolled in KORNERSTONE with a biopsy proven GN. Eligible participants must be scheduled for a clinically indicated renal biopsy. | Other: Kidney Biopsy<br>* Patients scheduled to undergo a clinically indicated kidney biopsy will be requested to consent to an additional renal core and various patient-derived samples.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | Documentation of death from any cause | 60 months | 
| Deterioration of renal outcomes | Doubling of serum creatinine compared to baseline serum creatinine 30% decline in follow-up estimated GFR (using the MDRD equation and/or the CKD-EPI equation) compared to baseline measurement End stage renal disease defined as estimated GFR ≤10cc/min, initiation of maintenance dialysis or kidney transplantation. | 60 months | 
| Improvement of clinical outcomes | Remission of glomerulonephritis and proteinuria <0.3g/day (pateint who have proteinuria<0.3g/day at baseline have no improvement in clinical outcomes) | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Malignancies | Any cancer diagnosis of the skin, hematopoietic system, or solid organ after enrollment | 60 months | 
| Infections, Serious and Systemic | Documented infection of any vital organ requiring the use of parenteral and/or oral antibiotics. | 60 months | 
| Acute Kidney Injury | Documented diagnosis of acute kidney injury as defined by the RIFLE criteria and/or renal failure requiring renal replacement therapy <3 months. | 60 months | 
| Hospitalization | Documented hospital admission, including observation for ≥24 hours. | 60 months | 
| Emergency Department/ Observation Unit Visit | Documented visit to an emergency department or observation unit that does not lead to hospitalization and is less than 24 hours. | 60 months | 
| Cardiovascular/Cerebrovascular event | Myocardial infarction; Congestive heart failure; Primary intractable serious arrhythmia; Peripheral vascular disease; Ischemic cerebrovascular accident; Hemorrhagic cerebrovascular accident; Thromboembolic event | 60 months | 
| New Onset Diabetes | Diagnosis of diabetes as indicated by 1 or more of the following not present at enrollment Documented diagnosis of diabetes in medical record 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% | 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glomerular disease, sample repository, clinical data, digital pathology repository, web-based database