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出境医 / 临床实验 / KOrea Renal Biobank NEtwoRk System TOward NExt-generation Analysis (KORNERSTONE)

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

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 Intervention/treatment
Glomerular Disease Minimal Change Disease IgA Nephropathy Membranous Nephropathy Focal Segmental Glomerulosclerosis Lupus Nephritis Crescentic Glomerulonephritis 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 Design
Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 20 Years
Official Title: Multicenter Prospective Cohort of Kidney Biopsy for Glomerular Disease Research
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : December 31, 2028
Estimated Study Completion Date : December 31, 2028
Arms 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.
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 ]
    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.

  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. Malignancies [ Time Frame: 60 months ]
    Any cancer diagnosis of the skin, hematopoietic system, or solid organ after enrollment

  2. Infections, Serious and Systemic [ Time Frame: 60 months ]
    Documented infection of any vital organ requiring the use of parenteral and/or oral antibiotics.

  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

    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%


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
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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
Layout table for location 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
Layout table for location information
Korea, Republic of
KangWon National University Hospital Recruiting
Chuncheon, Korea, Republic of
Contact: Sunhwa Lee, MD       bucibuci@hanmail.net   
Principal Investigator: Ji In Park, MD         
Sub-Investigator: Sunhwa Lee, MD         
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of
Contact: Yaerim Kim, MD, PhD       yaerim86@gmail.com   
Principal Investigator: Seungyeup Han, MD, PhD         
Sub-Investigator: Yaerim Kim, MD, PhD         
Chung-Ang University Hosptial Recruiting
Seoul, Korea, Republic of
Contact: Jin Ho Hwang, MD, PhD         
Principal Investigator: Jin Ho Hwang, MD, PhD         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Yong Chul Kim, MD, PhD    +82-10-8874-7429    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         
Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jung Tak Park, MD, PhD       JTPARK@yuhs.ac   
Principal Investigator: Jung Tak Park, MD, PhD         
Sub-Investigator: Beom Jin Lim, MD, PhD         
SMG-SNU Boramae Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Jung Nam An, MD, PhD       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         
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
Layout table for investigator information
Study Director: Dong Ki Kim, MD, PhD Seoul National University Hospital
Tracking Information
First Submitted Date April 25, 2019
First Posted Date April 29, 2019
Last Update Posted Date February 12, 2020
Actual Study Start Date May 1, 2019
Estimated Primary Completion Date December 31, 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 10, 2020)
  • Death [ Time Frame: 60 months ]
    Documentation of death from any cause
  • Deterioration of renal outcomes [ Time Frame: 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.
  • 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)
Original Primary Outcome Measures
 (submitted: April 25, 2019)
  • Death [ Time Frame: 60 months ]
    Documentation of death from any cause
  • Renal Outcome [ Time Frame: 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. 50% decline in follow-up estimated GFR (using the MDRD equation and/or the CKD-EPI equation) compared to baseline measurement
    4. End stage renal disease defined as estimated GFR ≤10cc/min, initiation of maintenance dialysis or kidney transplantation.
Change History
Current Secondary Outcome Measures
 (submitted: April 25, 2019)
  • Malignancies [ Time Frame: 60 months ]
    Any cancer diagnosis of the skin, hematopoietic system, or solid organ after enrollment
  • Infections, Serious and Systemic [ Time Frame: 60 months ]
    Documented infection of any vital organ requiring the use of parenteral and/or oral antibiotics.
  • 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.
  • Hospitalization [ Time Frame: 60 months ]
    Documented hospital admission, including observation for ≥24 hours.
  • 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.
  • 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
  • New Onset Diabetes [ Time Frame: 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%
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title KOrea Renal Biobank NEtwoRk System TOward NExt-generation Analysis
Official Title Multicenter Prospective Cohort of Kidney Biopsy for Glomerular Disease Research
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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 20 Years
Biospecimen Retention:   Samples With DNA
Description:

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.
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.
Condition
  • Glomerular Disease
  • Minimal Change Disease
  • IgA Nephropathy
  • Membranous Nephropathy
  • Focal Segmental Glomerulosclerosis
  • Lupus Nephritis
  • Crescentic Glomerulonephritis
Intervention 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.
Study Groups/Cohorts 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.

Intervention: Other: Kidney Biopsy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 2, 2019) 		3000
Original Estimated Enrollment
 (submitted: April 25, 2019) 		7000
Estimated Study Completion Date December 31, 2028
Estimated Primary Completion Date December 31, 2028   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
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
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT03929887
Other Study ID Numbers KORNERSTONE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: 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.
Responsible Party Dong Ki Kim, Seoul National University Hospital
Study Sponsor Seoul National University Hospital
Collaborators
  • 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
PRS Account Seoul National University Hospital
Verification Date February 2020

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