NCT07035834尚未招募4 期
SGLT-2 Inhibitors on Albuminuria in Chronic Kidney Disease Patients With Lupus Nephritis and ANCA- Associated Vasculitis: Study Design and Protocol
Federico II University0 个研究点目标入组 40 人开始时间: 2025年9月1日最近更新:
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- The variation of albuminuria
研究概览
简要总结
The goal of this clinical trial is to investigate the effect of the glifozines on albuminuria in chronic kidney disease patients affected by lupus nephritis and ANCA associated renal vasculitis. It will also learn about the safety of glifozines. The main questions it aims to answer are:
- Does glifozines lower the albuminuria of participants with chronic kidney disease secondary to lupus nephritis and ANCA associated renal vasculitis?
- What medical problems do participants have when taking glifozines?
Participants will:
- Take glifozines every day for 6 months.
- Baseline, 1 month and 6-month visits will be scheduled to collect demographic, clinical, biochemical, and urinary data.
- A psychosocial assessment will be performed.
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
- •patients aged more than18 years with chronic kidney disease from stage 1 to3, secondary to confirmed LN, without active LN, and AAV
排除标准
- •allergy or intolerance to SGLT2i exposure within 1month before screening; 2) recurrent urinary tract infections; 3) hepatic dysfunction (aspartate aminotransferase or alanine aminotransferase levels >2 times the upper normal limits); 4) an eGFR ˂30 ml/min/1.73 m2; 5) DM type I and II.
研究组 & 干预措施
Lupus nephritis and ANCA associated vasculitis patients treated with glifozines
Experimental
干预措施: Gliflozin (Drug)
结局指标
主要结局
The variation of albuminuria
时间窗: From enrollment to the end of treatment at 6 months
The primary outcome is the variation of albuminuria after 6 months of treatment with SGLT-2i.
时间窗: From enrollment to the end of treatment at 6 months
次要结局
未报告次要终点
研究者
Ivana Capuano
Researcher
Federico II University
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