Lupus Nephritis study: Dapagliflozin
Official title Dapagliflozin in Active Lupus Nephritis
ClinicalTrials.gov ID: NCT07323524
What this study is testing
What is Dapagliflozin 10 mg Tablet?
An investigational oral medication being studied for early and active lupus nephritis. It is designed to inhibit sodium-glucose co‑transporters in the kidney to reduce glucose reabsorption.
Also referred to as Dapagliflozin.
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
- This study is testing whether dapagliflozin added to usual care helps people with early lupus nephritis. It compares the drug to a pretend treatment.
- Who it's for
- You may be able to join if you are a young person with early, active lupus nephritis and are already receiving standard care.
- What's involved
- You will take a small pill of dapagliflozin or a pretend pill, and you will have regular check‑ups and blood tests to see how your kidneys are doing.
- Time commitment
- The study lasts about 12 months, with visits every few months to monitor your health.
- 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
- 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...
- Recent or ongoing glucocorticoids use for active LN within the past 6 months
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
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.