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The Efficacy of Empagliflozin on Kidney Functions in Lupus Nephritis Population

2026年7月14日 更新者：Ahmed Yehia Ismail

Does The Positive Reno-Protective Effect Of Sodium Glucose Co-Transporter 2 Inhibitors Extend To Lupus Nephritis Population?

Systemic lupus erythematosis (SLE) is a chronic, most probably auto-immune multisystem disease marked by relapsing-remitting course and the formation of a range of autoantibodies. SLE patients present with serious renal (lupus nephritis (LN)), cardiopulmonary, or nervous manifestation. LN occurs in 40%-70% of SLE cases during the first 10 years of disease and is marked by the presence of proteinuria (hallmark).

A novel class of medications had been extracted from phlorizin and indicated for the treatment of type 2 diabetes (T2D), referred to as Sodium glucose cotransporter 2 (SGLT-2) inhibitors. They act by decreasing glucose reabsorption in the proximal renal tubules (SGLT2). Previous studies proved that SGLT2 inhibitors resulted in decreased postprandial hyperglycemia, enhanced glycemic control, reduced body weight and blood pressure, and albuminuria in those with T2D. Large placebo-controlled trials such as Empagliflozin-Kidney (EMPA-Kidney) and Dapagliflozin in Patients with Chronic Kidney Disease (DAPA-CKD) trial demonstrated the efficacy of empagliflozin and dapagliflozin, respectively, in patients with chronic kidney disease (CKD) regardless the diabetic cause of CKD, compared to placebo. EMPA-Kidney with median 2.0 years of follow-up reported that empagliflozin (EMPA) significantly (P<0.001) lowered (13.1%) the risk of progression of kidney disease and death from cardiovascular causes than placebo (16.9%). Together with, DAPA-CKD trial reported that the risk of a composite of a sustained decline in the estimated GFR of at least 50% was significantly (P<0.001) lower in the DAPA group (9.2%) compared to placebo group (14.5%) over a median of 2.4 years of follow-up. However, such studies excluded lupus nephritis population from clinical trials.

Consequently, an experimental study is conducted to test the hypothesis that SGLT2 inhibitor EMPA is superior to placebo in improving proteinuria and estimated glomerular filtration rate (eGFR) in a group of patients with established LN already receiving the usual standard care and treatment.

The trial participants compatabile with the elgibility criteria will be randomly assigned to two groups. One group will take Empagliflozin 25 mg tablet each day along with the standard care therapy. The other group will take a matching placebo besides the usual standard care therapy during the clinical trial period.

Study outcomes will be measured three times, one before starting the medical study, the second and third will be 6 and 12 weeks after starting the clinical study, respectively. After that, the statistical siginficance of values between both groups will be reported to test the credibilty of the hypothesis.

The study is primarily designed to evaluate the reno-protective effect of EMPA on kidney function, in terms of urinary protein-creatinine ratio (uPCR)and eGFR.

Empagliflozin efficacy testing in lupus nephritis population (EMPA-LN) is a prospective, randomized, triple-blinded, parallel-group, placebo controlled phase 4 trial recruiting 66 subjects. A 10% drop-out rate is anticipated based on the clinical opinion of the care provider. The study will be conducted in accordance with the declaration of Helsinki. An ethical approval will be provided from an ethics committee.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

66

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 埃及
      • Banī Suwayf、埃及
        • 招聘中
        • Beni-suef university Hospital
        • 接触：
        • 副研究员：
          • Seif

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Adults (≥ 18 years) with established biopsy-proven LN of active III, IV, overlapping III/IV, or overlapping III/V classes.
  • eGFR ≥ 30 ml.min1.1.73m-2,
  • Urinary protein creatinine ratio (uPCR) > 1000 mg/g.

Exclusion Criteria:

  • Subjects with serious hypersensitivity (angioedema and/or anaphylaxis) to EMPA.
  • eGFR < 30 ml.min-1.1.73m-2.
  • uPCR < 1000 mg/g.
  • Type 1 or 2 diabetes.
  • Aterial fibrillation.
  • Hepatic impairment [defined as alanine transaminase or aspartate transaminase >3 times the upper limit of normal (ULN) or total bilirubin >2 times the ULN at the time of enrolment].
  • Any condition outside the renal and cardiovascular study area with a life expectancy of < 6 months based on care provider's clinical judgment.
  • Those who enrolled in an experimental study in the previous 6 months.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：每天一次安慰剂
药品：Placebo and standard of care
The placebo includes a matching tablet similar to empagliflozin tablet in shape, color, and size. Each participant randomly assigned to the Placebo group will administer one tablet each day along with the usual standard medical therapy within the clinical study period
其他名称：
  • 匹配安慰剂
  • inactive gredient
实验性的：Empagliflozin 25 mg once daily
药品：Empagliflozin (25 Mg Tab) along with standard medical therapy
The intervention includes empagliflozin 25 mg tablet once daily, empagliflozin is a sodium glucose cotransporter-2 inhibitor (SGLT2I) medication that provides a glycemic control, furthermore, it is reported its antiproteinuric effect and improving the kidney function. Each participant randomly assigned to the interventional group will administer one tablet each day provided with the usual standard care therapy within the clinical study period.
其他名称：
  • EMPA
  • SGLT2Is

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Urinary protein-creatinine ratio (UPCR)
大体时间：From recruitment (week 0) to the end of treatment (week 12)
The difference in change in UPCR from baseline to the first follow-up (1.5 months) and to the end of the treatment period (3 months) between both the placebo and EMPA groups.
From recruitment (week 0) to the end of treatment (week 12)
Estimated glomerular filtration rate (eGFR)
大体时间：From recruitment (week 0) to the end of treatment (week 12)
The difference in change in eGFR from baseline to the first follow-up (1.5 months) and to the end of the treatment period (3 months) between both the placebo and EMPA groups.
From recruitment (week 0) to the end of treatment (week 12)

次要结果测量

结果测量
措施说明
大体时间
The tolerance and safety
大体时间：From enrollment (week 0) to 4 weeks following the end of the treatment (week 12)
The relative risk of adverse events reported between both treatment groups at 4 weeks following the end of the treatment (3 months).
From enrollment (week 0) to 4 weeks following the end of the treatment (week 12)
Fasting plasma glucose (FBG)
大体时间：From enrollment (week 0) to the end of treatment (week 12)
The difference in change from baseline in FBG to the first follow-up (1.5 months) and to the end of the treatment period (3 months) between study groups.
From enrollment (week 0) to the end of treatment (week 12)
Systolic (SBP) and diastolic (DBP) blood pressure
大体时间：From enrollment (week 0) to the end of treatment (week 12)
The difference in change from baseline in systolic (SBP) and diastolic blood pressure (DBP) to the first follow-up (1.5 months) and to the end of the treatment period (3 months) between study groups.
From enrollment (week 0) to the end of treatment (week 12)
Hemoglobin (Hb) level
大体时间：From enrollment (week 0) to the end of treatment (week 12)
The difference in change from baseline in Hb level to the first follow-up (1.5 months) and to the end of the treatment period (3 months) between study groups.
From enrollment (week 0) to the end of treatment (week 12)
Hematocrit level
大体时间：From enrollment (week 0) to the end of treatment (week 12)
The difference in change from baseline in hematocrit level to the first follow-up (1.5 months) and to the end of the treatment period (3 months) between study groups.
From enrollment (week 0) to the end of treatment (week 12)
Glycated hemoglobin (HbA1c)
大体时间：From enrollment (week 0) to the end of treatment (week 12)
The difference in change from baseline in HbA1c to the end of the treatment period (3 months) between study groups
From enrollment (week 0) to the end of treatment (week 12)
Adverse events and safety
大体时间：From enrollment (week 0) to the end of treatment (week 12)
The proportion of adverse events reported in EMPA and placebo groups throughout the research study (3 months).
From enrollment (week 0) to the end of treatment (week 12)
Partial response
大体时间：From enrollment (week 0) to the end of treatment (week 12)
Proportion of subjects that reach partial renal response in terms of UPCR (defined as ≥ 50% decline in UPCR from baseline value to ˂ 3000 mg/g of creatinine from a 24-h urine collection)
From enrollment (week 0) to the end of treatment (week 12)
Body weight
大体时间：From enrollment (week 0) to the end of treatment (week 12)
The difference in change from baseline in body weight to 1st follow-up (1.5 months) and to the end of the treatment period (3 months) between study groups.
From enrollment (week 0) to the end of treatment (week 12)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Ahmed Yehia Ismail

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年1月22日

初级完成 (估计的)

2026年12月30日

研究完成 (估计的)

2026年12月30日

研究注册日期

首次提交

2026年7月8日

首先提交符合 QC 标准的

2026年7月8日

首次发布 (实际的)

2026年7月14日

研究记录更新

最后更新发布 (实际的)

2026年7月15日

上次提交的符合 QC 标准的更新

2026年7月14日

最后验证

2025年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • GLIFALN0066

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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