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

Multicenter Prospective Cohort of Kidney Biopsy for Glomerular Disease Research

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.

Study Overview

• Status: Recruiting
• Conditions: Lupus Nephritis; Focal Segmental Glomerulosclerosis; IgA Nephropathy; Glomerular Disease; Minimal Change Disease; Membranous Nephropathy; Crescentic Glomerulonephritis
• Intervention / Treatment: Other: Kidney Biopsy

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 Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Yong Chul Kim, MD,PhD.; Phone Number: +82-10-8874-7429; Email: imyongkim@gmail.com
• Study Contact Backup: Name: Eunyoung Kim; Phone Number: +82-2-6072-5188; Email: irish-key@nate.com

Study Locations

• Korea, Republic of
  • Chuncheon, Korea, Republic of
    • Recruiting
    • Kangwon National University Hospital
    • Contact: Sunhwa Lee, MD; Email: bucibuci@hanmail.net
    • Principal Investigator: Ji In Park, MD
    • Sub-Investigator: Sunhwa Lee, MD
  • Daegu, Korea, Republic of
    • Recruiting
    • Keimyung University Dongsan Medical Center
    • Contact: Yaerim Kim, MD, PhD; Email: yaerim86@gmail.com
    • Principal Investigator: Seungyeup Han, MD, PhD
    • Sub-Investigator: Yaerim Kim, MD, PhD
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: Yong Chul Kim, MD, PhD; Phone Number: +82-10-8874-7429; Email: imyongkim@gmail.com
    • Principal Investigator: Dong Ki Kim, MD, PhD
    • Sub-Investigator: Hajeong Lee, MD, PhD
    • Sub-Investigator: Yon Su Kim, MD, PhD
    • Sub-Investigator: Kwon Wook Joo, MD, PhD
    • Sub-Investigator: Seung Seok Han, MD, PhD
    • Sub-Investigator: Hee Gyung Kang, MD, PhD
    • Sub-Investigator: Kyung Chul Moon, MD, PhD
    • Sub-Investigator: Eunjeong Kang, MD
    • Sub-Investigator: Seung Hee Yang, PhD
    • Sub-Investigator: Nan Kyung Lee, MS
    • Sub-Investigator: Eunyoung Kim, BN
  • Seoul, Korea, Republic of
    • Recruiting
    • Severance Hospital
    • Contact: Jung Tak Park, MD, PhD; Email: JTPARK@yuhs.ac
    • Principal Investigator: Jung Tak Park, MD, PhD
    • Sub-Investigator: Beom Jin Lim, MD, PhD
  • Seoul, Korea, Republic of
    • Recruiting
    • SMG-SNU Boramae Medical Center
    • Contact: Jung Nam An, MD, PhD; Email: lovingjn@gmail.com
    • Principal Investigator: Jung Pyo Lee, MD, PhD
    • Sub-Investigator: Jeonghwan Lee, MD, PhD
    • Sub-Investigator: Jung Nam An, MD, PhD
    • Sub-Investigator: Jeong Hwan Park, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Chung-Ang University Hosptial
    • Contact: Jin Ho Hwang, MD, PhD
    • Principal Investigator: Jin Ho Hwang, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

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
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
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
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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Seoul National University Bundang Hospital; Chung-Ang University Hosptial, Chung-Ang University College of Medicine; SMG-SNU Boramae Medical Center; Severance Hospital; Keimyung University Dongsan Medical Center; Ministry of Health & Welfare, Korea; KangWon National University Hospital
• Investigators: Study Director: Dong Ki Kim, MD, PhD, Seoul National University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Anticipated): December 31, 2028
• Study Completion (Anticipated): December 31, 2028

Study Registration Dates

• First Submitted: April 25, 2019
• First Submitted That Met QC Criteria: April 25, 2019
• First Posted (Actual): April 29, 2019

Study Record Updates

• Last Update Posted (Actual): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: clinical data; Glomerular disease; sample repository; digital pathology repository; web-based database
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Urologic Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Nephrosis; Kidney Diseases; Glomerulonephritis; Nephritis; Lupus Nephritis; Glomerulosclerosis, Focal Segmental; Glomerulonephritis, IGA; Glomerulonephritis, Membranous; Nephrosis, Lipoid
• Other Study ID Numbers: KORNERSTONE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
• IPD Sharing Time Frame: Data will be available within 6 months of study completion.
• IPD Sharing Access Criteria: Data access requests will be reviewed by an external independent Review Panel. Requestors will be required to sign a Data Access Agreement.
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No