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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

Tracking Information
First Submitted Date April 25, 2019
First Posted Date April 29, 2019
Last Update Posted Date April 29, 2019
Actual Study Start Date January 1, 2010
Estimated Primary Completion Date December 31, 2028   (Final data collection date for primary outcome measure)
Current 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
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 Multicenter Prospective Cohort of Kidney Biopsy for Glomerular Disease Research
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 (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.

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
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 who have clinical features of glomerulonephritis and confirmed by renal biopsy.
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 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.

Intervention: Other: Kidney Biopsy
Publications * Not Provided

*   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: April 25, 2019)
7000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2028
Estimated Primary Completion Date December 31, 2028   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 15 Years and older   (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 K-BIO Network
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 April 2019