Dapagliflozin in Active Lupus Nephritis

NCT07323524 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2025P003238
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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)

Keywords

dapagliflozin; SGLT2 inhibitor; safety; feasibility; pilot trial

Outcome Measures

Primary Outcomes (1)

• Proportion of eligible enrolled

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

  3 years

Secondary Outcomes (1)

• Feasibility of data collection

  3 years

Other Outcomes (2)

• Change in urine protein-to-creatinine ratio

  12 weeks per subject

• Adverse outcomes

  3 years

Study Arms (2)

Dapagliflozin 10 mg daily

ACTIVE COMPARATOR

Subjects will receive masked dapagliflozin 10 mg daily for 12 weeks

Drug: Dapagliflozin (10Mg Tab) along with standard medical therapy

Matching placebo pill daily

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Placebo DRUG

Matching placebo daily with standard of care

Matching placebo pill daily

Dapagliflozin (10Mg Tab) along with standard medical therapy DRUG

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

Dapagliflozin 10 mg daily

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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

Sponsors & Collaborators

• Massachusetts General Hospital: collaborator
• Brigham and Women's Hospital: lead

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Lupus Nephritis

Interventions

dapagliflozin; Tablets

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Karen H Costenbader, MD, MPH

CONTACT

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

April M Jorge, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Physician, Rheumatologist

Model Details: Pilot and feasibility, 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.

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 7, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

US (2)