KOrea Renal Biobank NEtwoRk System TOward NExt-generation Analysis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorSeoul National University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

* Patient suspected of glomerular disease who received kidney biopsy in participating university medical centers

Children (age<18 years) also included

Disqualifiers

Patients who previously received a kidney transplant

Trial population

Patients suspected of glomerular diseases who received kidney biopsy in participating university medical centres are eligible for inclusion in the KORNERSTONE.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Kidney Biopsy

    Other intervention

    Patients scheduled to undergo a clinically indicated kidney biopsy will be requested to consent to an additional renal core and various patient-derived samples.

Treatment groups

3,000 Participants
are divided into 1 treatment group
Group A: KORNERSTONE1 intervention

Trial outcomes

Primary outcomes

1

Death

Documentation of death from any cause

Time frame
60 months
2

Deterioration of renal outcomes

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.

Time frame
60 months
3

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)

Time frame
60 months

Secondary outcomes

1

Malignancies

Any cancer diagnosis of the skin, hematopoietic system, or solid organ after enrollment

Time frame
60 months
2

Infections, Serious and Systemic

Documented infection of any vital organ requiring the use of parenteral and/or oral antibiotics.

Time frame
60 months
3

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.

Time frame
60 months
4

Hospitalization

Documented hospital admission, including observation for ≥24 hours.

Time frame
60 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Hospital

Lead sponsor

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Collaborator

KangWon National University Hospital

Collaborator

Keimyung University Dongsan Medical Center

Collaborator

SMG-SNU Boramae Medical Center

Collaborator

Seoul National University Bundang Hospital

Collaborator

Severance Hospital

Collaborator

Ministry of Health & Welfare, Korea

Collaborator