Recruiting

Dapagliflozin

Sponsor:

Brigham and Women's Hospital

Code:

NCT07323524

Conditions

Lupus Nephritis (LN)

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Dapagliflozin (10Mg Tab) along with standard medical therapy

Placebo

Study Details

Brief summary:

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.

Conditions

Lupus Nephritis (LN)

Study ID

NCT07323524

Start date

May 19, 2026

Status verified date

May, 2026

Completion date

Jan, 2030

Anticipated

Primary completion date

Jul, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

33 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Dapagliflozin 10 mg daily

Subjects will receive masked dapagliflozin 10 mg daily for 12 weeks

placebo comparator: Matching placebo pill daily

Subjects will receive a matching placebo pill to take daily for 12 weeks

Interventions

Dapagliflozin (10Mg Tab) along with standard medical therapy

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

Placebo

Matching placebo daily with standard of care

Primary outcome measure

  • Proportion of eligible enrolled [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Karen H Costenbader, MD, MPH

(617) 525-8785kcostenbader@bwh.harvard.edu

April M Jorge, MD

617-643-9624amjorge@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

April M. Jorge, MD

617-643-9624amjorge@mgh.harvard.edu

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Karen H. Costenbader, MD, MPH

617-732-6088KCostenbader@bwh.harvard.edu

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

May 26, 2026

Last verified

May, 2026

Keywords

  • dapagliflozin
  • SGLT2 inhibitor
  • safety
  • feasibility
  • pilot trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-05-26.