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Multicenter Prospective Cohort of Kidney Biopsy for Glomerular Disease Research (K-BIO)

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ClinicalTrials.gov Identifier: NCT03929887
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
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
Information provided by (Responsible Party):
Dong Ki Kim, Seoul National University Hospital

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 (K-BIO Network).

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 (K-BIO Network).

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 7000 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 : January 1, 2010
Estimated Primary Completion Date : December 31, 2028
Estimated Study Completion Date : December 31, 2028


Group/Cohort Intervention/treatment
K-BIO Cohort

Glomerulonephritis (GN) such as Minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), Membranous nephropathy (MN), and Immunoglobulin A nephropathy (IgAN)

Participants enrolled in K-BIO Network 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.




Primary Outcome Measures :
  1. Death [ Time Frame: 60 months ]
    Documentation of death from any cause

  2. 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.


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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who have clinical features of glomerulonephritis and confirmed by renal biopsy.
Criteria

Inclusion Criteria:

  • Diagnosis of glomerulonephritis (MCD, FSGS, MN, IgAN, RPGN, lupus nephritis and etc.) on first diagnostic kidney biopsy, as per specified pathology definitions
  • First diagnostic kidney biopsy since 2010
  • Willingness to comply with study requirements, including intention to fully participate in protocol-specified follow-up at a clinical study site
  • Informed consent and, where age appropriate, informed assent (clinical data, human derived materials including genomic data)

Exclusion Criteria:

  • Unwillingness to give informed consent
  • Not enough kidney tissue to confirm a diagnosis (adequate tissue: more than 2 cores of kidney tissues (10 x 1.2 mm) including over 10-15 glomerulus each)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929887


Contacts
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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
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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         
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Korea, Republic of
Contact: Jong Cheol Jeong, MD       jcj0425@empas.com   
Principal Investigator: Ho Jun Chin, MD, PhD         
Sub-Investigator: Jong Cheol Jeong, MD         
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: 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
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Study Director: Dong Ki Kim, MD, PhD Seoul National University Hospital

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Responsible Party: Dong Ki Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03929887     History of Changes
Other Study ID Numbers: K-BIO Network
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dong Ki Kim, Seoul National University Hospital:
Glomerular disease
sample repository
clinical data
digital pathology repository
web-based database
Additional relevant MeSH terms:
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Kidney Diseases
Nephritis
Lupus Nephritis
Glomerulonephritis, IGA
Glomerulonephritis
Glomerulosclerosis, Focal Segmental
Glomerulonephritis, Membranous
Nephrosis, Lipoid
Urologic Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Nephrosis