Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
33 (estimated)
Sponsor
Brigham and Women's Hospital · Other
Who this trial is looking for
This trial is looking for people aged 18-70 with active lupus nephritis. Participants will receive dapagliflozin or a placebo alongside their usual treatments.
Are You a Good Fit for This Trial?
Must be takingMycophenolateCyclophosphamideBelimumabAzathioprineCalcineurin inhibitorsB cell depleting therapies
You may be able to join if
I am between 18 and 70 years old.
I have been diagnosed with lupus and have proven kidney involvement.
I have active lupus nephritis within the past six months.
I am receiving standard treatment for active lupus nephritis.
I have used glucocorticoids for my condition in the past 6 months.
I have protein in my urine above a certain level.
I can give my informed consent.
You may not be able to join if
I have severely reduced kidney function.
I have had a sudden increase in creatinine in the last 90 days.
I have type 1 diabetes.
I am underweight with a BMI under 18.5.
I currently have an active cancer or infection.
I am pregnant or planning to become pregnant without contraception.
I am taking too much prednisone right now.
I have used certain diabetes medications before.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 …
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.
Trial Locations
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Eligibility Criteria
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
…
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
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