Genomic analysis of different stages of Chronic Kidney Disease (CKD) in Indian Population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Identification of signature biomarkers via a minimally invasive procedure will enable
研究概览
简要总结
Study Synopsis
Study Number: SLS-CKD-01
Study Title: Genomic analysis of different stages of Chronic Kidney Disease (CKD) in
Indian Population
Study Sponsor: Strand Life Sciences Private Limited
Study Type: Exploratory, Observational, Non-interventional, Multi-centric
Study Site(s): Multiple
Total number of Subjects: 1000 (250 for each cohort)
Study Arms:
Arm 1: Affected arm subdivided into 4 cohorts:
Cohort I: Mild CKD (eGFR 60-89 ml/min)
Cohort II: Moderate to Severe CKD (eGFR 30-59 ml/min)
Cohort III: Severe CKD (eGFR 15-29 ml/min)
Cohort IV: End Stage CKD (eGFR <15 ml/min)
Rationale
Given the rising prevalence of this disease in India, it would be beneficial to carry out ethnically diverse
multi-centric large-scale research. To understand the genotype-phenotype associations with the different
stages of CKD, this study intends to sequence patients with different stages of CKD in comparison to
healthy persons without symptoms or a susceptibility to the disease.Successful completion of the study
will aid in the identification of potential genomic markers for identifying high-risk people who are at risk
of getting CKD may be discovered and also identify potential therapeutic targets for the disease.
Objective
To discover genotype-phenotype correlations in individuals with different stages of diagnosed CKD
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals of 18 years or above with confirmed diagnosis of CKD with eGFR less than 90 ml/min and other available clinical parameters (age of onset, method of diagnosis, phenotypic characteristics, any information on repeated occurrence, associated SOC test results) Individuals from the general population of any sex and race Individuals who has the ability to understand and willing to sign the Informed consent form Willingness to contribute 20-23 ml blood.
排除标准
- •Patients with acute nephrology disorders or disorders pertaining to autoimmune or genetic conditions like lupus nephritis or polycystic kidney disease Patients not consenting or unable to give an informed written consent Patients not meeting the inclusion criteria or judged by the investigator to be unsuitable for inclusion into the study Pregnant or lactating women.
结局指标
主要结局
Identification of signature biomarkers via a minimally invasive procedure will enable
时间窗: 5 years
identification of pivotal genetic factors that contribute to the development and progression of
时间窗: 5 years
different stages of CKD.
时间窗: 5 years
次要结局
未报告次要终点
研究者
Dr Vamsi Veeramachaneni
Strand Life Sciences Pvt Ltd