KOrea Renal Biobank NEtwoRk System TOward NExt-generation Analysis

NCT03929887 | Recruiting DMC

• 1 other identifier: KORNERSTONE
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 6

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.

Conditions

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

Keywords

Glomerular disease; sample repository; clinical data; digital pathology repository; web-based database

Outcome Measures

Primary Outcomes (3)

• Death

  Documentation of death from any cause

  60 months

• Deterioration of renal outcomes

  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.

  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 Outcomes (7)

• Malignancies

  60 months

• Infections, Serious and Systemic

  60 months

• Acute Kidney Injury

  60 months

• Hospitalization

  60 months

• Emergency Department/ Observation Unit Visit

  60 months

Study Arms (1)

KORNERSTONE

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

Interventions

Kidney Biopsy OTHER

Patients scheduled to undergo a clinically indicated kidney biopsy will be requested to consent to an additional renal core and various patient-derived samples.

KORNERSTONE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients suspected of glomerular diseases who received kidney biopsy in participating university medical centres are eligible for inclusion in the KORNERSTONE.

You may qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Chung-Ang University Hosptial, Chung-Ang University College of Medicine: collaborator
• KangWon National University Hospital: collaborator
• Keimyung University Dongsan Medical Center: collaborator
• SMG-SNU Boramae Medical Center: collaborator
• Seoul National University Bundang Hospital: collaborator
• Severance Hospital: collaborator
• Ministry of Health & Welfare, Korea: collaborator

Study Sites (6)

KangWon National University Hospital

Chuncheon, South Korea

RECRUITING

Keimyung University Dongsan Medical Center

Daegu, South Korea

RECRUITING

Chung-Ang University Hosptial

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Severance Hospital

Seoul, South Korea

RECRUITING

SMG-SNU Boramae Medical Center

Seoul, South Korea

RECRUITING

Related Publications (1)

• Kang E, Kim Y, Kim YC, Kim E, Lee N, Kim Y, Lee S, Han S, Choe M, Hwang JH, Lee S, Park JI, Park JT, Lim BJ, Lee JP, An JN, Ryu DR, Kim JH, Kang HG, Lee HS, Moon KC, Joo KW, Oh KH, Han SS, Lee H, Kim DK; KORNERSTONE Study Group. Biobanking for glomerular diseases: a study design and protocol for KOrea Renal biobank NEtwoRk System TOward NExt-generation analysis (KORNERSTONE). BMC Nephrol. 2020 Aug 26;21(1):367. doi: 10.1186/s12882-020-02016-z.

  PMID: 32842999 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

plasma, serum, genomic DNA, buffy coat, urine, stool, glomerular cDNA, tubulointerstitial cDNA, kidney biopsy slides (digitalized) These sample are acquired at kidney biopsy, annually afterwords, and at the time of clinical endpoint if possible.

MeSH Terms

Conditions

Nephrosis, Lipoid; Glomerulonephritis, IGA; Glomerulonephritis, Membranous; Glomerulosclerosis, Focal Segmental; Lupus Nephritis

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glomerulonephritis; Nephritis; Autoimmune Diseases; Immune System Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Dong Ki Kim, MD, PhD

  Seoul National University Hospital

  STUDY DIRECTOR

Central Study Contacts

Yong Chul Kim, MD,PhD.

CONTACT

+82-10-8874-7429; imyongkim@gmail.com

Eunyoung Kim

CONTACT

+82-2-6072-5188; irish-key@nate.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: April 29, 2019
• Study Start: May 1, 2019
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 12, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data will be available within 6 months of study completion.
• Access Criteria: Data access requests will be reviewed by an external independent Review Panel. Requestors will be required to sign a Data Access Agreement.

Locations

KR (6)