Dapagliflozin added to standard care for active lupus nephritis
Tests dapagliflozin against placebo, alongside standard care, in adults with early active lupus nephritis.
Plain-language title generated from the registry record
Registry title: Dapagliflozin in Active Lupus Nephritis
Key facts
- Where
- Boston, United StatesSee the 2 sites
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07323524, who can take part
Where in United States
- Brigham and Women's HospitalBoston, United StatesTaking people
- Massachusetts General HospitalBoston, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Brigham and Women's Hospital
- Trial code
- NCT07323524
- Record updated
- 6 November 2026
- Original description
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.Read full original descriptionShow less
Sodium-Glucose Co-Transporter-2 Inhibitors in Lupus Nephritis
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.
Inclusion: • 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: 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.