NCT07323524RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Sodium-Glucose Co-Transporter-2 Inhibitors in Lupus Nephritis
Source: ClinicalTrials.gov · Last updated 26 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 33 (estimated)
- First submitted
- 5 Jan 2026
- Start date
- 19 May 2026
- Primary completion date
- Jul 2029
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Lupus (SLE)
- NCT number
- NCT07323524
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 33
- From 19 May 2026 to the primary completion date, Jul 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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
Who the study is looking for
- • 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.