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 volunteersQualifiers
* 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
Cohort
Prospective
Treatments tested in this trial
Kidney Biopsy
Other interventionPatients 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
Trial outcomes
Primary outcomes
Death
Documentation of death from any cause
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.
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)
Secondary outcomes
Malignancies
Any cancer diagnosis of the skin, hematopoietic system, or solid organ after enrollment
Infections, Serious and Systemic
Documented infection of any vital organ requiring the use of parenteral and/or oral antibiotics.
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.
Hospitalization
Documented hospital admission, including observation for ≥24 hours.
Sponsors and contacts
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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