Who is eligible for clinical trial NCT07323524?

Participants must meet the protocol's inclusion criteria for Lupus Nephritis (LN). The stated age range is 18 Years to 70 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT07323524 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-05-21

Dapagliflozin in Active Lupus Nephritis (NCT07323524)

Sodium-Glucose Co-Transporter-2 Inhibitors in Lupus Nephritis

🟢 Recruiting Phase4 💊 Investigational Drug / Biologic Sponsor: Brigham and Women's Hospital

🩺 Plain-English Summary (8th-Grade Level)

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 join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (7 items).

Location: Massachusetts General Hospital — Boston, Massachusetts

Age range: 18 Years to 70 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

• 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

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

Massachusetts General Hospital — Boston, Massachusetts
Brigham and Women's Hospital — Boston, Massachusetts

📞 Contact the Study Coordinator

Phone: (617) 525-8785

Email: kcostenbader@bwh.harvard.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Lupus Nephritis (LN)

Dose Escalation Study With Bispecific Antibodies in Adult Participants With Lupus Nephritis — Rochester, Minnesota
Safety and Efficacy of ONT01 in Lupus — New York, New York
Dapagliflozin to Reduce the Decline in Renal Function in Patients Newly Diagnosed With Lupus Nephritis — Guadalajara, Jalisco

Explore by condition: All Lupus Nephritis (LN) clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗