达格列净治疗活动性狼疮性肾炎 (Dapa-Active LN)
钠-葡萄糖协同转运蛋白-2抑制剂在狼疮性肾炎中的应用
Lupus nephritis is a chronic and life-threatening autoimmune cause of kidney disease that predominately impacts young people and can lead to kidney failure. Sodium-glucose co-transporter-2 inhibitors, including dapagliflozin, are known to improve outcomes for people with other causes of chronic kidney disease. This pilot and feasibility randomized clinical trial will test the use of dapagliflozin versus placebo in addition to standard of care treatment for patients with early and active lupus nephritis, a group who has not been included in past trials.
研究概览
地位
条件
详细说明
This is a pilot and feasibility randomized, double-blind, placebo-controlled trial involving patients with active lupus nephritis. It will be a concealed allocation, blinded randomized controlled trial of dapagliflozin 10 mg/day or matched placebo in a 2:1 allocation ratio (22 subjects active arm: 11 subjects placebo arm), in addition to standard-of-care treatment, for 12 weeks. After informed consent, 33 eligible subjects will be randomized 2:1 to oral dapagliflozin 10 mg/day or identical oral placebo/day for 12 weeks. Study visits will occur at screening (Visit -1), baseline (Visit 0) and weeks 4 (Visit 1), 8 (Visit 2) and 12 (Visit 3). Observational data including laboratory test results obtained in routine clinical care will be collected through 12 months of follow-up.
The primary outcomes are:
- the overall proportion of identified as potentially eligible/pre-screened patients who enroll in the trial;
- feasibility and completeness of data collection procedures;
- changes in urine protein-to-creatinine ratio (UPCR) and precision of these estimates from baseline to week 12 in each group; and
- rates and proportions of serious adverse events and of adverse events of interest, including genitourinary infections and volume depletion.
研究类型
注册 (估计的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名：Karen H Costenbader, MD, MPH
- 电话号码：(617) 525-8785
- 邮箱：kcostenbader@bwh.harvard.edu
研究联系人备份
- 姓名：April M Jorge, MD
- 电话号码：617-643-9624
- 邮箱：amjorge@mgh.harvard.edu
学习地点
-
-
Massachusetts
-
Boston、Massachusetts、美国、02115
- 招聘中
- Brigham and Women's Hospital
-
接触：
- Karen H. Costenbader, MD, MPH
- 电话号码：617-732-6088
- 邮箱：KCostenbader@bwh.harvard.edu
-
Boston、Massachusetts、美国、02114
- 招聘中
- Massachusetts General Hospital
-
接触：
- April M. Jorge, MD
- 电话号码：617-643-9624
- 邮箱：amjorge@mgh.harvard.edu
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
-
• Age 18-70 years, fulfilling 2012 SLICC or 2019 ACR/EULAR criteria for SLE, with biopsy-proven class III, IV and/or V LN
-
Active (new or relapsing) LN within the prior six months, with at least one of the following:
- Kidney biopsy with activity index >2 and/or
- Active urinary sediment (>5 RBCs, >5 WBCs, or cellular casts)
-
Receiving standard-of-care immunosuppression regimen for active LN, including mycophenolate, cyclophosphamide, belimumab, azathioprine, a calcineurin inhibitor, and/or B cell depleting therapies
-
Recent or ongoing glucocorticoids use for active LN within the past 6 months
-
Receiving standard-of-care antimalarial therapy and RAAS blockade, unless contraindicated
-
Estimated ≥0.5 g/g 24 hr proteinuria or ≥0.3 mg/g 24 hr microalbuminuria at enrollment (on first morning urine)
-
Ability to given informed consent
-
Exclusion Criteria:
-
GFR < 25 ml/min/1.73m2
- Acute kidney injury at study enrollment (>50 percent rise in creatinine within 90 days)
- Type I diabetes, underweight (BMI <18.5), active malignancy, active infection, or recurrent genitourinary infections
- For females: pregnancy, or desiring of pregnancy and not using contraception, or unable to use contraception
- Current use of >1mg/kg/day prednisone equivalent
- Current or prior use of SGLT2 inhibitors or GLP-1 receptor agonists
学习计划
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 |
|---|---|
|
有源比较器：Dapagliflozin 10 mg daily
Subjects will receive masked dapagliflozin 10 mg daily for 12 weeks |
Pilot and feasibility of adding dapagliflozin to standard medical therapy in active lupus nephritis (LN) |
|
安慰剂比较：Matching placebo pill daily
Subjects will receive a matching placebo pill to take daily for 12 weeks |
Matching placebo daily with standard of care |
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 |
|---|---|---|
|
Proportion of eligible enrolled
大体时间：3 years
|
The overall proportion of identified as potentially eligible/pre-screened patients who enroll in the trial |
3 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Feasibility of data collection
大体时间：3 years
|
We will assess the percent of missing data elements overall at pilot trial completion. |
3 years
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in urine protein-to-creatinine ratio
大体时间：12 weeks per subject
|
Change in urine protein-to-creatinine ratio (UPCR) from baseline to week 12 in each group |
12 weeks per subject
|
|
Adverse outcomes
大体时间：3 years
|
Rates and proportions of serious adverse events and of adverse events of interest, including genitourinary infections and volume depletion |
3 years
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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