Dapagliflozin in Active Lupus Nephritis
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Brigham and Women's Hospital
- Study ID
- NCT07323524
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- Lupus Nephritis (LN)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Dapagliflozin (10Mg Tab) along with standard medical therapy — DRUGPilot and feasibility of adding dapagliflozin to standard medical therapy in active lupus nephritis (LN)
- Placebo — DRUGMatching placebo daily with standard of care
Study Details
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.
Key Dates
- Start date
- May 19, 2026
- Status verified
- May 2026
- Primary completion
- Jul 31, 2029
- Completion
- Jan 31, 2030
Study Design
- Enrollment
- 33 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Dapagliflozin 10 mg dailySubjects will receive masked dapagliflozin 10 mg daily for 12 weeks
- Placebo Comparator: Matching placebo pill dailySubjects will receive a matching placebo pill to take daily for 12 weeks
Primary Outcome Measure
Proportion of eligible enrolled [ Time Frame: 3 years ]
Central Contacts
- Karen H Costenbader, MD, MPH(617) 525-8785
- April M Jorge, MD617-643-9624
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 |
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