Multicenter Prospective Cohort of Kidney Biopsy for Glomerular Disease Research
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 6
- 主要终点
- Death
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Death
时间窗: 60 months
Documentation of death from any cause
Improvement of clinical outcomes
时间窗: 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)
Deterioration of renal outcomes
时间窗: 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.
次要结局
- Emergency Department/ Observation Unit Visit(60 months)
- Infections, Serious and Systemic(60 months)
- Cardiovascular/Cerebrovascular event(60 months)
- New Onset Diabetes(60 months)
- Malignancies(60 months)
- Acute Kidney Injury(60 months)
- Hospitalization(60 months)
研究者
Dong Ki Kim
Professor
Seoul National University Hospital