KOrea Renal Biobank NEtwoRk System TOward NExt-generation Analysis

NCT03929887 · tracked via the Priya Life Science South Korea tracker

Sponsor

Seoul National University Hospital

Phase

Observational

Started

2019-05-01

Last updated

2020-02-12

Condition(s) studied

Glomerular DiseaseMinimal Change DiseaseIgA NephropathyMembranous NephropathyFocal Segmental GlomerulosclerosisLupus NephritisCrescentic Glomerulonephritis

Investigational drug(s) / intervention(s)

Kidney Biopsy

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 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 (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

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

1. Inclusion criteria * Patient suspected of glomerular disease who received kidney biopsy in participating university medical centers * Children (age\<18 years) also included 2. Exclusion criteria - Patients who previously received a kidney transplant

Primary outcome measure(s)

Death — 60 months
Documentation of death from any cause
Deterioration of renal outcomes — 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. End stage renal disease defined as estimated GFR ≤10cc/min, initiation of maintenance dialysis or kidney transplantation.
Improvement of clinical outcomes — 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)

Trial sites (6)

Facility	City	Region	Status
KangWon National University Hospital	Chuncheon	South Korea	Recruiting
Keimyung University Dongsan Medical Center	Daegu	South Korea	Recruiting
Chung-Ang University Hosptial	Seoul	South Korea	Recruiting
Seoul National University Hospital	Seoul	South Korea	Recruiting
Severance Hospital	Seoul	South Korea	Recruiting
SMG-SNU Boramae Medical Center	Seoul	South Korea	Recruiting

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Other trials for the same condition

Study of WAL0921 in Patients With Glomerular Kidney Diseases Recruiting

Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension) Recruiting

A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS) Recruiting

A Study of JADE101 in Participants With Immunoglobulin A Nephropathy Recruiting

Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03929887 on ClinicalTrials.gov ↗ ← All trials in South Korea