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临床试验/NCT07288723
NCT07288723已完成不适用

Chronic Kidney Disease : Role of Biological Factors and Apolipoprotein L1 Encoding Gene

Centre Hospitalier Universitaire de la Guadeloupe1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2023年4月6日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
88
试验地点
1
主要终点
Frequency of alleles (G1 and G2) of APOL1

研究概览

简要总结

Chronic kidney disease (CKD) is a major global public health issue. The present project focuses on the role of apolipoprotein L1 (APOL1) in patients with stage 4 CKD (glomerular filtration rate between 15 and 29 mL/min/1.73 m²).

详细描述

Chronic kidney disease (CKD) is a worldwide public health problem. The project concerns the apolopoprotein L1 at stage 4 of severe chronic kidney disease (defined by a glomerular filtration rate of 29-15 ml / min / 1.73 m2).

Traditional risk factors (diabetes, cardiovascular diseases) and non-traditional such as inflammation and malnutrition are prognostic factors of mortality in our population.

Other parameters, less frequently described, would predict complications and mortality in patients on dialysis and in pre-dialysis the Fibroblast growth factor-23 (FGF-23) that regulates phosphates metabolism (Pereira, Juppner et al. 2009) and the " N terminal fragment of brain natriuretic peptide" (NT-proBNP), which plays a major role in regulation of blood pressure and extracellular volume.

Studies have suggested that black populations (African Americans) have a more rapid decline in kidney function than whites (European Americains).

The role of two variants (G1 and G2) of the gene encoding apolipoprotein L1 (APOL1) was mentioned. These APOL1 variants are common in African Americans (more than 50% are carriers of at least one risk allele). Carriers of 2 risk alleles would present a more rapid progression to end stage and, high-risk genotypes would explain most of the excess CKD risk for people of African descent. These variants of APOL1 Chronic kidney disease (CKD) is a worldwide public health problem. Our project concerns the apolopoprotein L1 at stage 4 of severe chronic kidney disease (defined by a glomerular filtration rate of 29-15 ml / min / 1.73 m2).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 18 y and older, of both sexes, Afro Caribbeans
  • Living in Guadeloupe
  • Having been informed of objectives and constraints of the study and who have given their written consent.
  • For patients with CKD : at stage 4 (GFR < than 30 ml / min / 1.73m2.), whatever the etiology of CKD, associated pathologies and treatments,
  • For patients with normal renal function : serum creatinine < 10 mg/l.

排除标准

  • Patients 18 y and older, of both sexes, Afro Caribbeans
  • Living in Guadeloupe
  • Having been informed of objectives and constraints of the study and who have given their written consent.
  • For patients with CKD : at stage 4 (GFR < than 30 ml / min / 1.73m2.), whatever the etiology of CKD, associated pathologies and treatments,
  • For patients with normal renal function : serum creatinine < 10 mg/l.

结局指标

主要结局

Frequency of alleles (G1 and G2) of APOL1

时间窗: At baseline (study inclusion).

The frequency of APOL1 risk alleles (G1 and G2 variants) will be determined in patients with stage 4 chronic kidney disease (CKD). This measure aims to describe the distribution of APOL1 genotypes within the study population and to identify the proportion of participants carrying one or two risk alleles, which may inform the analysis of associations with clinical and biochemical outcomes. Genotyping of APOL1 variants using DNA extracted from EDTA blood samples, analyzed by validated molecular biology techniques.

次要结局

  • Prevalence of Diabetes(At baseline (study inclusion))
  • Prevalence of Hypertension(At baseline (study inclusion))
  • Prevalence of Malnutrition(At baseline (study inclusion))
  • Echocardiographic Abnormalities(At baseline (study inclusion))
  • Presence of Vascular Calcifications(At baseline (study inclusion))
  • Plasma NT-proBNP concentration (pg/mL)(At baseline (study inclusion).)
  • Plasma Concentration of FGF-23(At baseline (study inclusion))

研究者

发起方
Centre Hospitalier Universitaire de la Guadeloupe
申办方类型
Other
责任方
Sponsor

研究点 (1)

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