Dapagliflozin in Active Lupus Nephritis

ConditionLupus Nephritis (LN)

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-70

SponsorBrigham and Women's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• 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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Dapagliflozin (10Mg Tab) along with standard medical therapy
Drug
Pilot and feasibility of adding dapagliflozin to standard medical therapy in active lupus nephritis (LN)
Placebo
Drug
Matching placebo daily with standard of care

Treatment groups

33 Participants

are divided into 2 treatment groups

Group A: Dapagliflozin 10 mg dailyActive comparator 1 intervention

Group B: Matching placebo pill dailyPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Proportion of eligible enrolled

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

Time frame

3 years

Secondary outcomes

Feasibility of data collection

We will assess the percent of missing data elements overall at pilot trial completion.

Time frame

3 years

Other outcomes

Change in urine protein-to-creatinine ratio

Change in urine protein-to-creatinine ratio (UPCR) from baseline to week 12 in each group

Time frame

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

Time frame

3 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

Massachusetts General Hospital

Collaborator

Source ClinicalTrials.gov

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