Dapagliflozin in Active Lupus Nephritis (Dapa-Active LN)

Sodium-Glucose Co-Transporter-2 Inhibitors in Lupus Nephritis

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.

Study Overview

• Status: Recruiting
• Conditions: Lupus Nephritis (LN)
• Intervention / Treatment: Drug: Dapagliflozin (10Mg Tab) along with standard medical therapy; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 33
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Karen H Costenbader, MD, MPH; Phone Number: (617) 525-8785; Email: kcostenbader@bwh.harvard.edu
• Study Contact Backup: Name: April M Jorge, MD; Phone Number: 617-643-9624; Email: amjorge@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Karen H. Costenbader, MD, MPH; Phone Number: 617-732-6088; Email: KCostenbader@bwh.harvard.edu
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: April M. Jorge, MD; Phone Number: 617-643-9624; Email: amjorge@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dapagliflozin 10 mg daily; Subjects will receive masked dapagliflozin 10 mg daily for 12 weeks	Drug: Dapagliflozin (10Mg Tab) along with standard medical therapy; Pilot and feasibility of adding dapagliflozin to standard medical therapy in active lupus nephritis (LN)
Placebo Comparator: Matching placebo pill daily; Subjects will receive a matching placebo pill to take daily for 12 weeks	Drug: Placebo; Matching placebo daily with standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of eligible enrolled	The overall proportion of identified as potentially eligible/pre-screened patients who enroll in the trial	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of data collection	We will assess the percent of missing data elements overall at pilot trial completion.	3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in urine protein-to-creatinine ratio	Change in urine protein-to-creatinine ratio (UPCR) from baseline to week 12 in each group	12 weeks per subject
Adverse outcomes	Rates and proportions of serious adverse events and of adverse events of interest, including genitourinary infections and volume depletion	3 years

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: January 5, 2026
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: safety; feasibility; SGLT2 inhibitor; dapagliflozin; pilot trial
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Lupus Erythematosus, Systemic; Nephritis; Skin and Connective Tissue Diseases; Lupus Nephritis; Pharmaceutical Preparations; Dosage Forms; Tablets; dapagliflozin
• Other Study ID Numbers: 2025P003238

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No