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Dapagliflozin for Active Lupus Nephritis

This study is looking at whether adding dapagliflozin to standard treatment can help people with active lupus nephritis (LN). Lupus nephritis is a kidney disease caused by lupus, an autoimmune condition. Dapagliflozin is a medication known to help people with other types of kidney disease. This trial will compare dapagliflozin (10mg daily) with a placebo (a pill with no medicine) in addition to your usual care. You might be able to join if you are 18-70 years old, have lupus nephritis confirmed by a kidney biopsy, and have active kidney disease. The main goals are to see how many eligible people join the study, how well data can be collected, and to look at changes in a urine protein marker and any side effects over 12 weeks. The study is currently unclear about its recruitment status.

Study design
This is a randomized, double-blind, placebo-controlled study, meaning participants are randomly assigned to receive either dapagliflozin or a placebo, and neither you nor your doctor will know which you are receiving. About 33 participants will be enrolled.
What's involved
You would take either dapagliflozin or placebo daily for 12 weeks. You would have study visits at screening, baseline, and at weeks 4, 8, and 12.
Compensation
Not stated in the trial record.
Follow-up
Observational data, including laboratory test results from routine clinical care, will be collected for 12 months after the 12-week treatment period.

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NCT07323524

Dapagliflozin in Active Lupus Nephritis

Recruiting
PHASE4Ages 18–70InterventionalTreatment
Brigham and Women's Hospital
~33 participants
Updated 2026-05-26 on ClinicalTrials.gov
What's tested:Dapagliflozin (10Mg Tab) along with standard medical therapyPlacebo

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of eligible enrolled
Measured over 3 years

Conditions

Lupus Nephritis (LN)

Explore related trials

Lupus Glomerulonephritis

Where it's being run

2 sites across 1 states
Massachusetts2

Who to contact

Karen H Costenbader, MD, MPH
[email protected]
(617) 525-8785
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

• 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

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

What this trial measures

  • Proportion of eligible enrolled3 years

    The overall proportion of identified as potentially eligible/pre-screened patients who enroll in the trial