Renasight Clinical Application, Review and Evaluation (RenaCARE) Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Natera, Inc.
- 入组人数
- 1,720
- 试验地点
- 61
- 主要终点
- Number of participants with changed treatment or clinical management and new clinical diagnoses established based on Renasight test results.
研究概览
简要总结
This study is an open-label, multi-center study evaluating the clinical utility of Renasight in the diagnosis and management of kidney disease.
详细描述
Patients who are prospectively enrolled in the study will have blood or buccal swab samples sent to the Natera clinical lab for Renasight testing at the time of enrollment. Physicians will receive Renasight test results which may be used in clinical decision-making. At enrollment and at 1 month and 1 year following enrollment, clinical data will be submitted, and physician and subject questionnaires will be completed. Additional clinical follow-up and patient questionnaires may be completed at 2 and 3 years following enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all the following selection criteria to be eligible for the study. Eligibility will be assessed by the investigator:
- •Male or female patients, age 18 years or older at the time of signing the informed consent form (ICF). If over the age of 65, patient must have a family history of CKD or clinical suspicion of genetic disorder.
- •Able to read, understand, and provide written informed consent
- •Willing and able to comply with the study-related procedures
- •Diagnosis of kidney disease, and/or one of the following without any kidney biopsy (note: can be newly diagnosed or existing patient):
- •Nephropathy associated with Diabetes Mellitus (DM)*
- •Nephropathy associated with Hypertension*
- •Cystic nephropathy*
- •Congenital nephropathy
- •Tubulointerstitial disease of unknown etiology
- •Proteinuric disease suggestive of a primary glomerulopathy by clinical evaluation
- •Early, severe or familial hypertension
- •Thrombotic microangiopathy
- •Electrolyte and acid base disorder
- •Nephrolithiasis with family history
- •CKD of unknown cause after standard nephrological evaluation
- •End stage kidney disease (ESRD) *Total number of patients in each of these categories will not exceed 10% of total cohort
排除标准
- •Patients are not eligible for the study if they meet any of the following criteria, as assessed by the investigator:
- •Age less than 18, or greater than 65 without a family history of CKD or clinical suspicion of genetic disorder
- •History of renal transplant
- •Clinical features and a kidney biopsy diagnosis strongly indicative of a secondary nephropathy (e.g., diabetic nephropathy, lupus nephritis, acute kidney injury)
- •Previously confirmed diagnosis of a hereditary kidney disease via genetic testing.
结局指标
主要结局
Number of participants with changed treatment or clinical management and new clinical diagnoses established based on Renasight test results.
时间窗: Within 3 years and 6 months of recruitment close
The enrolling physician will complete baseline questionnaires, 1-month post-result questionnaires, and 1-year follow-up questionnaires. Changes to pre-result planned management as well as new diagnostic information will be assessed. Pre-result and post-result surveys will be reviewed for all subjects, regardless of test results.
Frequency of positive test results of Renasight compared to frequency of positive test results of phenotypic panels
时间窗: Within 6 months of recruitment close
The frequency of positive test results of the Renasight panel will be compared to phenotype-specific commercial panels virtually reconstructed from the Renasight gene content. The frequency of positive test results will also be compared across different clinical categories of disease in the study population.
Test Positive Prevalence: The frequency of positive test results across the entire cohort and within different categories of kidney disorders will be analyzed.
时间窗: Within 3 months of recruitment close
Frequency of positive test results is defined as the number of patients in a given category with a genetic finding on Renasight divided by the total number of patients in that category. Changes in diagnosis from baseline physician questionnaire to post-result physician questionnaire will be classified
次要结局
- Evaluate the impact of Renasight on patient satisfaction, health knowledge and genetics literacy.(Within 2 years of recruitment close)
- Evaluate the impact of Renasight on family outcomes.(Within 2 years of recruitment close)