Dapagliflozin in Active Lupus Nephritis

NCT ID: NCT07323524

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2030-01-31

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.

Detailed Description

This is a pilot and feasibility randomized, double-blind, placebo-controlled trial involving patients with active lupus nephritis. It will be a concealed allocation, blinded randomized controlled trial of dapagliflozin 10 mg/day or matched placebo in a 2:1 allocation ratio (22 subjects active arm: 11 subjects placebo arm), in addition to standard-of-care treatment, for 12 weeks. After informed consent, 33 eligible subjects will be randomized 2:1 to oral dapagliflozin 10 mg/day or identical oral placebo/day for 12 weeks. Study visits will occur at screening (Visit -1), baseline (Visit 0) and weeks 4 (Visit 1), 8 (Visit 2) and 12 (Visit 3). Observational data including laboratory test results obtained in routine clinical care will be collected through 12 months of follow-up.

The primary outcomes are:

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

2. feasibility and completeness of data collection procedures;

3. changes in urine protein-to-creatinine ratio (UPCR) and precision of these estimates from baseline to week 12 in each group; and

4. rates and proportions of serious adverse events and of adverse events of interest, including genitourinary infections and volume depletion.

Conditions

Lupus Nephritis (LN)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dapagliflozin 10 mg daily

Subjects will receive masked dapagliflozin 10 mg daily for 12 weeks

Group Type: ACTIVE_COMPARATOR

Dapagliflozin (10Mg Tab) along with standard medical therapy

Intervention Type: DRUG

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

Matching placebo pill daily

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo daily with standard of care

Interventions

Dapagliflozin (10Mg Tab) along with standard medical therapy

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

Intervention Type: DRUG

Placebo

Matching placebo daily with standard of care

Intervention Type: DRUG

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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Karen H. Costenbader

Associate Physician, Rheumatologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Central Contacts

Karen H Costenbader, MD, MPH

Role: CONTACT

kcostenbader@bwh.harvard.edu

(617) 525-8785

April M Jorge, MD

Role: CONTACT

amjorge@bwh.harvard.edu

617-643-9624

Facility Contacts

April M. Jorge, MD

Role: primary

amjorge@mgh.harvard.edu

617-643-9624

Karen H. Costenbader, MD, MPH

Role: primary

KCostenbader@bwh.harvard.edu

617-732-6088

Other Identifiers

2025P003238

Identifier Type: -

Identifier Source: org_study_id