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New treatment option for Lupus Nephritis (LN)
Official title Dapagliflozin in Active Lupus Nephritis
ClinicalTrials.gov ID: NCT07323524
What this study is testing
What is Dapagliflozin (10Mg Tab) along with standard medical therapy?
Dapagliflozin (10Mg Tab) along with standard medical therapy is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for lupus nephritis (ln).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.