Dapagliflozin in Active Lupus Nephritis
Recruiting · NCT07323524 · Interventional (participants receive a specific treatment) · Lead sponsor: Brigham and Women's Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Dapagliflozin (10Mg Tab) along with standard medical therapyPlacebo
What this trial is about
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.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed across 1 US state.
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Brigham and Women's Hospital - Boston, Massachusetts, United States