KOrea Renal Biobank NEtwoRk System TOward NExt-generation Analysis

Recruiting

• Conditions: Glomerular Disease; IgA Nephropathy; Membranous Nephropathy; Crescentic Glomerulonephritis; Minimal Change Disease; Focal Segmental Glomerulosclerosis; Lupus Nephritis
• Interventions: Other: Kidney Biopsy

• Registration Number: NCT03929887
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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\>

1. Blood tests: CBC, Chemistry (Ca, P, Glucose, Total protein, Albumin, Uric acid), Electrolyte, Renal function (BUN, Creatinine, eGFR), Liver function (AST, ALT)

2. Immunologic blood tests: Complement 3, Complement 4, ASO, RF, Cryoglobulin, dsDNA, ANA

3. Urine tests: Urinalysis, Urine protein, Urine albumin, Urine creatinine

4. Radiologic tests: Kidney USG, Abdominal-pelvis computed tomography

5. Pathologic results

6. Treatment informations: treatment status, drug type, treatment duration

7. Quality of life questionnaire: Kidney Disease and Quality of Life Short Form survey (adults), PedsQL 4.0 Generic Core Scales (pediatrics)

8. Dietary questionnaire

Study Timeline

• Study First Submitted: 2019-04-25
• Study First Submitted QC: 2019-04-25
• Study First Posted: 2019-04-29
• Study Start: 2019-05-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-12
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
KORNERSTONE	Kidney Biopsy	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.

Primary Outcome Measures

Name	Time	Method
Death	60 months	Documentation of death from any cause
Improvement of clinical outcomes	60 months	Remission of glomerulonephritis and proteinuria \<0.3g/day (pateint who have proteinuria\<0.3g/day at baseline have no improvement in clinical outcomes)
Deterioration of renal outcomes	60 months	1. Doubling of serum creatinine compared to baseline serum creatinine; 2. 30% decline in follow-up estimated GFR (using the MDRD equation and/or the CKD-EPI equation) compared to baseline measurement; 3. End stage renal disease defined as estimated GFR ≤10cc/min, initiation of maintenance dialysis or kidney transplantation.

Secondary Outcome Measures

Name	Time	Method
Emergency Department/ Observation Unit Visit	60 months	Documented visit to an emergency department or observation unit that does not lead to hospitalization and is less than 24 hours.
Infections, Serious and Systemic	60 months	Documented infection of any vital organ requiring the use of parenteral and/or oral antibiotics.
Cardiovascular/Cerebrovascular event	60 months	Myocardial infarction; Congestive heart failure; Primary intractable serious arrhythmia; Peripheral vascular disease; Ischemic cerebrovascular accident; Hemorrhagic cerebrovascular accident; Thromboembolic event
New Onset Diabetes	60 months	Diagnosis of diabetes as indicated by 1 or more of the following not present at enrollment; 1. Documented diagnosis of diabetes in medical record; 2. 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%
Malignancies	60 months	Any cancer diagnosis of the skin, hematopoietic system, or solid organ after enrollment
Acute Kidney Injury	60 months	Documented diagnosis of acute kidney injury as defined by the RIFLE criteria and/or renal failure requiring renal replacement therapy \<3 months.
Hospitalization	60 months	Documented hospital admission, including observation for ≥24 hours.

Trial Locations

Locations (6)

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

KangWon National University Hospital; 🇰🇷 Chuncheon, Korea, Republic of

Chung-Ang University Hosptial; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

SMG-SNU Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of