Sodium-Glucose Co-Transporter-2 Inhibitors in Lupus Nephritis
概览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Proportion of eligible enrolled
概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• 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
排除标准
- •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
研究组 & 干预措施
Dapagliflozin 10 mg daily
Subjects will receive masked dapagliflozin 10 mg daily for 12 weeks
干预措施: Dapagliflozin (10Mg Tab) along with standard medical therapy (Drug)
Matching placebo pill daily
Subjects will receive a matching placebo pill to take daily for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of eligible enrolled
时间窗: 3 years
The overall proportion of identified as potentially eligible/pre-screened patients who enroll in the trial
次要结局
- Feasibility of data collection(3 years)
研究者
Karen H. Costenbader
Associate Physician, Rheumatologist
Brigham and Women's Hospital