KOrea Renal Biobank NEtwoRk System TOward NExt-generation Analysis (KORNERSTONE)

Seoul National University

Status: Enrolling

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

Treatments: Other: Kidney Biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT03929887

KORNERSTONE

Details and patient eligibility

About

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.

Full 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

Enrollment: 3,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Inclusion criteria

   • Patient suspected of glomerular disease who received kidney biopsy in participating university medical centers
   • Children (age<18 years) also included

2. Exclusion criteria - Patients who previously received a kidney transplant

Trial design

3,000 participants in 1 patient group

KORNERSTONE

Description:

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.

Treatment:

Other: Kidney Biopsy