Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

Dapagliflozin in Active Lupus Nephritis

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

Dapagliflozin in Active Lupus Nephritis (NCT07323524) is a Phase 4 interventional studying Lupus Nephritis (LN), sponsored by Brigham and Women's Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 33 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - • 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 willing to sign a consent form Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Dapagliflozin (10Mg Tab) along with standard medical therapy

Pilot and feasibility of adding dapagliflozin to standard medical therapy in active lupus nephritis (LN)

DRUG

Placebo

Matching placebo daily with standard of care

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07323524), the sponsor (Brigham and Women's Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07323524 clinical trial studying?

Who can participate in NCT07323524?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07323524?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Related Lupus Nephritis (LN) Trials

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A Clinical Study of YTS109 Cells for the Treatment of R/R Autoimmune Diseases

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CD19-Directed Chimeric Antigen Receptor Autologous T Cells (CART19) for Lupus

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A Clinical Study of YTS109 Cell in R/R Systemic Lupus Erythematosus

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Source: ClinicalTrials.gov API v2 record for NCT07323524. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07323524. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.