Recurrence Post-transplant Observational Study in Focal Segmental Glomerulosclerosis (FSGS) and Minimal Change Disease (MCD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Time to FSGS Recurrence
研究概览
简要总结
The morbidity of recurrence of focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) after transplant is well-recognized and include contemporary reduction in quality of life, edema, early graft loss and mortality. Efforts to understand its mechanisms and improve its treatment have been limited by small sample sizes in single center studies and misclassification in registry studies. Recent advances in the understanding of the mechanisms of FSGS in the native kidney has reinvigorated the scientific community to develop a collaborative community to advance research into the epidemiology, mechanisms, interventions, and outcomes.
The purpose of RESOLVE is to gather a group of people with FSGS and MCD that have had or will have a kidney transplant to create a bank of information and biospecimens so researchers can more effectively study these diseases.
详细描述
RESOLVE is a multicenter, observational cohort study to examine the post-transplant course of patients with FSGS and MCD across the lifespan. The study is designed to collect both retrospective and prospective data as well as biospecimens and patient reported information. With multiple enrollment options, the study will allow investigators to define the incidence and prevalence of FSGS recurrence, describe the post-transplant course of patients with FSGS and MCD across the lifespan, and develop a biorepository to support future translational research studies to explore relevant disease mechanisms.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Retrospective non-consented participant group had a transplant from the year 2000 and onward.
- •Diagnosis of FSGS or MCD in the native kidney (prior to transplant).
排除标准
- •Pathologic diagnosis other than FSGS or MCD
- •FSGS or MCD secondary to a known disorder (e.g. lupus nephritis, Immunoglobulin A (IgA) nephropathy, malignancy)
结局指标
主要结局
Time to FSGS Recurrence
时间窗: 2 years after transplant
Time to Graft Failure
时间窗: 2 years after transplant
次要结局
- Proteinuria change over time(Baseline (at transplant), 2 years)
- Proportion with acute rejection(2 years after transplant)
- Define the Endophenotypes in each group of recurrent FSGS and MCD(2 years after transplant)
- Proportion with delayed graft function(2 years after transplant)
- Proportion of recurrence and time to graft failure(2 years after transplant)
研究者
Eloise Salmon
Assistant Professor of Pediatrics
University of Michigan