NCT07706946尚未招募不适用
A Prospective Study on Intravenous Chelator Therapy for Slowing Renal Function Progression in Patients With Type 2 Diabetic Nephropathy Combined With Lead Burden
The Fourth Affiliated Hospital of Zhejiang University School of Medicine0 个研究点目标入组 42 人开始时间: 2026年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 主要终点
- Change in estimated glomerular filtration rate (eGFR) from baseline at 12 months follow-up after intravenous lead chelation therapy
研究概览
简要总结
Based on previous basic experiments revealing that patients with type 2 diabetic nephropathy exhibit higher blood lead levels than the general population, this study aims to systematically evaluate the impacts of short-term and long-term blood lead exposure on renal function progression in such patients, so as to provide novel epidemiological evidence for clinical intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •1. Diagnosed with type 2 diabetic nephropathy;
- •Baseline blood lead level ≥5 µg/dl;
- •Chronic kidney disease stage ≤3;
- •24-hour urinary protein < 8 g;
- •Age ≥18 years old;
- •Able to provide written informed consent.
排除标准
- •1. Combined hypertension;
- •Combined hyperlipidemia;
- •History of autoimmune diseases;
- •Personal history of malignant tumors;
- •Reversible renal insufficiency (malignant hypertension, urinary tract infection, recent use of nephrotoxic drugs);
- •Past occupational lead exposure history;
- •Drug allergy to calcium disodium edetate;
- •Unable to complete follow-up or provide informed consent.
结局指标
主要结局
Change in estimated glomerular filtration rate (eGFR) from baseline at 12 months follow-up after intravenous lead chelation therapy
时间窗: 3 months of intravenous lead chelation intervention, followed by 12 months of follow-up assessment with detections every 3 months
次要结局
未报告次要终点
研究者
相似试验
Unknown
不适用
SGLT2 抑制剂对合并慢性肾脏病的 2 型糖尿患者不同钠含量饮食状态下近端小管钠重吸收的影响研究ChiCTR2500111504国家卫生健康委医药卫生科技发展研究中心临床研究科研专项
已完成
2 期
SGLT2 Adjunct in T1DNephropathy, DiabeticType 1 DiabetesNCT07591077Ain Shams University86
尚未招募
Unknown
A RANDOMISED ALLOCATED CLINICAL STUDY TO EVALUATE THE ANTI DIABETIC EFFECT OF SULPHUR, PHOSPHORUS AND THUJA OCCIDENTALISCTRI/2024/03/063404Self200
Unknown
不适用
该研究尚未获得伦理委员会批准，请于批准后再开始纳入参试者，并与我们联系上传批件。 维生素 D2 注射液在 2 型糖尿病治疗中的作用及安全性研究ChiCTR2200056380南京大成医药科技发展有限公司100
尚未招募
4 期
国欣医师：该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者，并与我们联系上传批件。 钠-葡萄糖共同转运体 2 抑制剂对早期 2 型糖尿病肾病患者视网膜血管压力变化的研究ChiCTR190002793160