Glomerular DiseaseKORNERSTONENCT03929887
KOrea Renal Biobank NEtwoRk System TOward NExt-generation Analysis
An observational study of Glomerular Disease and Minimal Change Disease, run by Seoul National University Hospital at 6 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glomerular Disease, Minimal Change Disease, IgA Nephropathy
- What is being tested?
- Kidney Biopsy
- How many people
- 3,000 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 1 May 2019to 31 Dec 2028
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients suspected of glomerular diseases who received kidney biopsy in participating university medical centres are eligible for inclusion in the KORNERSTONE.
- Inclusion criteria
- Patient suspected of glomerular disease who received kidney biopsy in participating university medical centers
- Children (age<18 years) also included
- Exclusion criteria - Patients who previously received a kidney transplant
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
South Korea6 sites, 6 recruiting
- Recruiting
KangWon National University Hospital
Chuncheon
Sunhwa Lee, MD, bucibuci@hanmail.net
Ji In Park, MD
- Recruiting
Keimyung University Dongsan Medical Center
Daegu
Yaerim Kim, MD, PhD, yaerim86@gmail.com
Seungyeup Han, MD, PhD
- Recruiting
Chung-Ang University Hosptial
Seoul
Jin Ho Hwang, MD, PhD
Jin Ho Hwang, MD, PhD
- Recruiting
Seoul National University Hospital
Seoul
Yong Chul Kim, MD, PhD, +82-10-8874-7429, imyongkim@gmail.com
Dong Ki Kim, MD, PhD
- Recruiting
Severance Hospital
Seoul
Jung Tak Park, MD, PhD, JTPARK@yuhs.ac
Jung Tak Park, MD, PhD
- Recruiting
SMG-SNU Boramae Medical Center
Seoul
Jung Nam An, MD, PhD, lovingjn@gmail.com
Jung Pyo Lee, MD, PhD
About this study
Official title: 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.
Read more
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.
Read the 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>
- Blood tests: CBC, Chemistry (Ca, P, Glucose, Total protein, Albumin, Uric acid), Electrolyte, Renal function (BUN, Creatinine, eGFR), Liver function (AST, ALT)
- Immunologic blood tests: Complement 3, Complement 4, ASO, RF, Cryoglobulin, dsDNA, ANA
- Urine tests: Urinalysis, Urine protein, Urine albumin, Urine creatinine
- Radiologic tests: Kidney USG, Abdominal-pelvis computed tomography
- Pathologic results
- Treatment informations: treatment status, drug type, treatment duration
- Quality of life questionnaire: Kidney Disease and Quality of Life Short Form survey (adults), PedsQL 4.0 Generic Core Scales (pediatrics)
- Dietary questionnaire
- Conditions
- Glomerular Disease, Minimal Change Disease, IgA Nephropathy, Membranous Nephropathy, Focal Segmental Glomerulosclerosis, Lupus Nephritis
- Being tested
- Kidney Biopsy
- Keywords
- Glomerular disease, sample repository, clinical data, digital pathology repository, web-based database
- Medical subject headings
- Nephrosis, Lipoid, Glomerulonephritis, IGA, Glomerulonephritis, Membranous, Glomerulosclerosis, Focal Segmental, Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kidney BiopsyOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Kidney Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Documentation of death from any cause
Measured: 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.
Measured: 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)
Measured: 60 months
Secondary outcomes (7)
Malignancies
Any cancer diagnosis of the skin, hematopoietic system, or solid organ after enrollment
Measured: 60 months
Infections, Serious and Systemic
Documented infection of any vital organ requiring the use of parenteral and/or oral antibiotics.
Measured: 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.
Measured: 60 months
Hospitalization
Documented hospital admission, including observation for ≥24 hours.
Measured: 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.
Measured: 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
Measured: 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%
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start1 May 2019
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glomerular DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chung-Ang University Hospital, 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
- Responsible party
- Principal investigator, Dong Ki Kim, Seoul National University Hospital
- Investigators
- Dong Ki Kim, MD, PhD, Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929887
- Sponsor's protocol ID
- KORNERSTONE
- Acronym
- KORNERSTONE
- Status last verified
- Feb 2020
- First submitted
- 25 Apr 2019
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
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.
PubMed 32842999
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Cohort of Kidney Biopsy for Glomerular Disease Research
- ClinicalTrials.gov ID
- NCT03929887
- Acronym / sponsor ID
- KORNERSTONE / KORNERSTONE
- Conditions
- Glomerular Disease, Minimal Change Disease, IgA Nephropathy, Membranous Nephropathy, Focal Segmental Glomerulosclerosis, Lupus Nephritis
- Keywords
- Glomerular disease, sample repository, clinical data, digital pathology repository, web-based database
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Chung-Ang University Hospital, 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
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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>
- Blood tests: CBC, Chemistry (Ca, P, Glucose, Total protein, Albumin, Uric acid), Electrolyte, Renal function (BUN, Creatinine, eGFR), Liver function (AST, ALT)
- Immunologic blood tests: Complement 3, Complement 4, ASO, RF, Cryoglobulin, dsDNA, ANA
- Urine tests: Urinalysis, Urine protein, Urine albumin, Urine creatinine
- Radiologic tests: Kidney USG, Abdominal-pelvis computed tomography
- Pathologic results
- Treatment informations: treatment status, drug type, treatment duration
- Quality of life questionnaire: Kidney Disease and Quality of Life Short Form survey (adults), PedsQL 4.0 Generic Core Scales (pediatrics)
- Dietary questionnaire
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KORNERSTONE | – | Other: Kidney BiopsyGlomerulonephritis (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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients suspected of glomerular diseases who received kidney biopsy in participating university medical centres are eligible for inclusion in the KORNERSTONE.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kidney BiopsyPatients scheduled to undergo a clinically indicated kidney biopsy will be requested to consent to an additional renal core and various patient-derived samples. | Other | KORNERSTONE |
Primary outcome
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)
7 secondary outcomes
Malignancies
Time frame: 60 months
Infections, Serious and Systemic
Time frame: 60 months
Acute Kidney Injury
Time frame: 60 months
Hospitalization
Time frame: 60 months
Emergency Department/ Observation Unit Visit
Time frame: 60 months
Cardiovascular/Cerebrovascular event
Time frame: 60 months
New Onset Diabetes
Time frame: 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Derived from this study: PubMed 32842999Kang 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dong Ki Kim, MD, PhD study director
Seoul National University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glomerular Disease and Minimal Change Disease, run by Seoul National University Hospital at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yong Chul Kim, MD,PhD. (+82-10-8874-7429, imyongkim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: 60 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03929887, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.