Dapagliflozin in Active Lupus Nephritis
ConditionLupus Nephritis (LN)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBrigham and Women's Hospital
About this trial
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.
Eligibility criteria
Qualifiers
• Age 18-70 years, fulfilling 2012 SLICC or 2019 ACR/EULAR criteria for SLE, with biopsy-proven class III, IV and/or V LN
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Dapagliflozin (10Mg Tab) along with standard medical therapy
- Placebo
Treatment groups
33 Participants
are divided into 2 treatment groupsSponsors and collaborators
Brigham and Women's Hospital
Lead sponsor
Massachusetts General Hospital
Collaborator
Source ClinicalTrials.gov