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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/25/2021.

KOrea Renal Biobank NEtwoRk System TOward NExt-generation Analysis

Clinicaltrials.gov identifier NCT03929887

Recruitment Status Recruiting

First Posted April 29, 2019

Last update posted February 12, 2020

Study Description

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.

  • Condition or Disease:Glomerular Disease
    Minimal Change Disease
    IgA Nephropathy
    Membranous Nephropathy
    Focal Segmental Glomerulosclerosis
    Lupus Nephritis
    Crescentic Glomerulonephritis
  • Intervention/Treatment: Other: Kidney Biopsy
  • Phase: N/A
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 Design
  • Study Type: Observational [Patient Registry]
  • Estimated Enrollment: 3000 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: Multicenter Prospective Cohort of Kidney Biopsy for Glomerular Disease Research
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: December 2028
  • Estimated Study Completion Date: December 2028
Groups and Cohorts
Groups/Cohorts 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.
Outcome Measures
  • Primary Outcome Measures: 1. Death [ Time Frame: 60 months ]
    Documentation of death from any cause
  • 2. Deterioration of renal outcomes [ Time Frame: 60 months ]
    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.
  • 3. Improvement of clinical outcomes [ Time Frame: 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)
  • Secondary Outcome Measures: 1. Infections, Serious and Systemic [ Time Frame: 60 months ]
    Documented infection of any vital organ requiring the use of parenteral and/or oral antibiotics.
  • 2. Malignancies [ Time Frame: 60 months ]
    Any cancer diagnosis of the skin, hematopoietic system, or solid organ after enrollment
  • 3. Acute Kidney Injury [ Time Frame: 60 months ]
    Documented diagnosis of acute kidney injury as defined by the RIFLE criteria and/or renal failure requiring renal replacement therapy <3 months.
  • 4. Hospitalization [ Time Frame: 60 months ]
    Documented hospital admission, including observation for ≥24 hours.
  • 5. Emergency Department/ Observation Unit Visit [ Time Frame: 60 months ]
    Documented visit to an emergency department or observation unit that does not lead to hospitalization and is less than 24 hours.
  • 6. Cardiovascular/Cerebrovascular event [ Time Frame: 60 months ]
    Myocardial infarction; Congestive heart failure; Primary intractable serious arrhythmia; Peripheral vascular disease; Ischemic cerebrovascular accident; Hemorrhagic cerebrovascular accident; Thromboembolic event
  • 7. New Onset Diabetes [ Time Frame: 60 months ]
    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%
  • 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.

Eligibility Criteria
  • Ages Eligible for Study: (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • 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.
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

Contacts and Locations
Contacts

Contact: Yong Chul Kim, MD,PhD. +82-10-8874-7429 imyongkim@gmail.com

Contact: Eunyoung Kim +82-2-6072-5188 irish-key@nate.com

Locations

Korea, Republic of
KangWon National University Hospital
Chuncheon

Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu

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

Sponsors and Collaborators

Seoul National University Hospital

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

KangWon National University Hospital

Keimyung University Dongsan Medical Center

SMG-SNU Boramae Medical Center

Seoul National University Bundang Hospital

Severance Hospital

Ministry of Health & Welfare, Korea

Investigators

Study Director: Dong Ki Kim, MD, PhD Seoul National University Hospital

More Information
  • Responsible Party: Seoul National University Hospital
  • ClinicalTrials.gov Identifier: NCT03929887 History of Changes
  • Other Study ID Numbers: KORNERSTONE
  • First Posted: April 29, 2019 Key Record Dates
  • Last Update Posted: February 12, 2020
  • Last Verified: February 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Yes
  • Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
  • Supporting Materials: Study Protocol, Informed Consent Form (ICF), Clinical Study Report (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.
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Seoul National University Hospital: Glomerular disease
    sample repository
    clinical data
    digital pathology repository
    web-based database
  • Additional relevant MeSH terms: Nephrosis, Lipoid
    Kidney Diseases
    Nephritis
    Lupus Nephritis
    Glomerulonephritis, IGA
    Glomerulonephritis
    Glomerulosclerosis, Focal Segmental
    Glomerulonephritis, Membranous