RecruitingRecruiting
Dapagliflozin in Active Lupus Nephritis
NCT07323524 · Brigham and Women's Hospital
In plain English
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Official title
Sodium-Glucose Co-Transporter-2 Inhibitors in Lupus Nephritis
About this study
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:
1. the overall proportion of identified as potentially eligible/pre-screened patients who enroll in the trial;
2. feasibility and completeness of data collection procedures;
3. changes in urine protein-to-creatinine ratio (UPCR) and precision of these estimates from baseline to week 12 in each group; and
4. rates and proportions of serious adverse events and of adverse events of interest, including genitourinary infections and volume depletion.
Eligibility criteria
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
Study design
Enrollment target: 33 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2026-05-19
Estimated completion: 2030-01
Last updated: 2026-05-26
Interventions
Drug: Dapagliflozin (10Mg Tab) along with standard medical therapyDrug: Placebo
Primary outcomes
- • Proportion of eligible enrolled (3 years)
Sponsor
Brigham and Women's Hospital · other
With: Massachusetts General Hospital
Contacts & investigators
ContactKaren H Costenbader, MD, MPH · contact · kcostenbader@bwh.harvard.edu · (617) 525-8785
ContactApril M Jorge, MD · contact · amjorge@mgh.harvard.edu · 617-643-9624
All locations (2)
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Brigham and Women's HospitalRecruiting
Boston, Massachusetts, United States