Association Between Chronic Kidney Disease Stage and Circulating FGF23 Cleavage Intensity in Patients With Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Evaluate the association between CKD stages and the intensity of circulating FGF23 cleavage in CKD patients.
研究概览
简要总结
This cross-sectional proof-of-concept study aims to investigate the relationship between chronic kidney disease (CKD) severity and circulating FGF23 (fibroblast growth factor 23) cleavage intensity estimated by the iFGF23/cFGF23 ratio. Eighty male patients aged 55-75 years with CKD stages 3a to 5 will be included (20 per stage). Blood samples obtained during routine nephrology care will be supplemented by two additional tubes to measure iFGF23, cFGF23, hepcidin, erythropoietin, 1,25-vitamin D and TRAP5b. The primary endpoint is the iFGF23/cFGF23 ratio. Secondary analyses will evaluate the associations between FGF23 forms and renal, hematological, iron metabolism and mineral bone parameters. This study will provide the first human data on FGF23 cleavage alterations across CKD stages and may identify novel biomarkers for anemia and cardiovascular complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •MRC stage 3a-5 based on the most recent GFR measurement
- •Patient enrolled in or eligible for a social security program
- •Patients who have received informed consent regarding the study and have given their verbal consent to participate
排除标准
- •Active cancer or a history of cancer in remission for less than 5 years, or a history of cancer in remission for more than 5 years with specific oncological treatment still ongoing.
- •Participation in another study related to treatments for the disease
- •Patients under legal guardianship (legal guardianship or conservatorship)
研究组 & 干预措施
Patients CKD 3a
Patients with stage 3a kidney disease during a nephrology consultation with an investigator (inclusion visit).
干预措施: Blood sampling and biomarker assessment (Other)
Patients CKD 3b
Patients with stage 3b kidney disease during a nephrology consultation with an investigator (inclusion visit).
干预措施: Blood sampling and biomarker assessment (Other)
Patients CKD 4
Patients with stage 3b kidney disease during a nephrology consultation with an investigator (inclusion visit).
干预措施: Blood sampling and biomarker assessment (Other)
Patients CKD 5
Patients with stage 5 kidney disease during a nephrology consultation with an investigator (inclusion visit).
干预措施: Blood sampling and biomarker assessment (Other)
结局指标
主要结局
Evaluate the association between CKD stages and the intensity of circulating FGF23 cleavage in CKD patients.
时间窗: At inclusion
The intensity of FGF23 cleavage will be estimated using the iFGF23/cFGF23 ratio and compared across CKD stages 3a to 5.
次要结局
- Plasma concentrations of iFGF23 and cFGF23(At inclusion)
- Association between FGF23 cleavage intensity and anemia-related parameters(At inclusion)
- Association between FGF23 concentrations and renal parameters(At inclusion)
- Association between FGF23 concentrations and mineral-bone metabolism markers(At inclusion)