Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03929887

KOrea Renal Biobank NEtwoRk System TOward NExt-generation Analysis

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.

Recruiting

Interested in participating?

Request Info

Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Kidney Biopsy

Other

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 outcomes

  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 outcomes

  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

    • 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%

Study contacts

Contact information is provided by the study sponsor or research team.

Eunyoung Kim

CONTACT

[email protected]

+82-2-6072-5188

Yong Chul Kim, MD,PhD.

CONTACT

[email protected]

+82-10-8874-7429

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Chung-Ang University Hospital
  • KangWon National University Hospital
  • Keimyung University Dongsan Medical Center
  • Ministry of Health & Welfare, Korea
  • SMG-SNU Boramae Medical Center
  • Seoul National University Bundang Hospital
  • Severance Hospital

Registry information

Official study title

Multicenter Prospective Cohort of Kidney Biopsy for Glomerular Disease Research

Acronym: KORNERSTONE

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Apr 29, 2019
Registry last updated
Feb 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.