Lupus Nephritis (LN)Phase 4Dapa-Active LNNCT07323524
Dapagliflozin in Active Lupus Nephritis
A Phase 4 study testing Dapagliflozin (10Mg Tab) along with standard medical therapy in people with Lupus Nephritis (LN), run by Brigham and Women's Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lupus Nephritis (LN)
- What is being tested?
- Dapagliflozin (10Mg Tab) along with standard medical therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 May 2026to Jan 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
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- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
April M. Jorge, MD, 617-643-9624, amjorge@mgh.harvard.edu
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Karen H. Costenbader, MD, MPH, 617-732-6088, KCostenbader@bwh.harvard.edu
About this study
Official title: 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.
Read the 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:
- the overall proportion of identified as potentially eligible/pre-screened patients who enroll in the trial;
- feasibility and completeness of data collection procedures;
- changes in urine protein-to-creatinine ratio (UPCR) and precision of these estimates from baseline to week 12 in each group; and
- rates and proportions of serious adverse events and of adverse events of interest, including genitourinary infections and volume depletion.
- Conditions
- Lupus Nephritis (LN)
- Being tested
- Dapagliflozin (10Mg Tab) along with standard medical therapy, Placebo
- Keywords
- dapagliflozin, SGLT2 inhibitor, safety, feasibility, pilot trial
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin (10Mg Tab) along with standard medical therapyDrug
Pilot and feasibility of adding dapagliflozin to standard medical therapy in active lupus nephritis (LN)
PlaceboDrug
Matching placebo daily with standard of care
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin 10 mg daily | Active comparator | Subjects will receive masked dapagliflozin 10 mg daily for 12 weeks Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eligible enrolled
The overall proportion of identified as potentially eligible/pre-screened patients who enroll in the trial
Measured: 3 years
Secondary outcomes (1)
Feasibility of data collection
We will assess the percent of missing data elements overall at pilot trial completion.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start19 May 2026
- Primary completionJul 2029 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Nephritis (LN)Studies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Principal investigator, Karen H. Costenbader, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323524
- Sponsor's protocol ID
- 2025P003238
- Acronym
- Dapa-Active LN
- Status last verified
- May 2026
- First submitted
- 5 Jan 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium-Glucose Co-Transporter-2 Inhibitors in Lupus Nephritis
- ClinicalTrials.gov ID
- NCT07323524
- Acronym / sponsor ID
- Dapa-Active LN / 2025P003238
- Conditions
- Lupus Nephritis (LN)
- Keywords
- dapagliflozin, SGLT2 inhibitor, safety, feasibility, pilot trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- 19 May 2026 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- the overall proportion of identified as potentially eligible/pre-screened patients who enroll in the trial;
- feasibility and completeness of data collection procedures;
- changes in urine protein-to-creatinine ratio (UPCR) and precision of these estimates from baseline to week 12 in each group; and
- rates and proportions of serious adverse events and of adverse events of interest, including genitourinary infections and volume depletion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin 10 mg daily | Active comparator | Drug: Dapagliflozin (10Mg Tab) along with standard medical therapySubjects will receive masked dapagliflozin 10 mg daily for 12 weeks |
| Matching placebo pill daily | Placebo comparator | Drug: PlaceboSubjects will receive a matching placebo pill to take daily for 12 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- • Age 18-70 years, fulfilling 2012 SLICC or 2019 ACR/EULAR criteria for SLE, with biopsy-proven class III, IV and/or V LN
Key exclusion criteria (6 listed)
- GFR < 25 ml/min/1.73m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin (10Mg Tab) along with standard medical therapyPilot and feasibility of adding dapagliflozin to standard medical therapy in active lupus nephritis (LN) | Drug | Dapagliflozin 10 mg daily |
| PlaceboMatching placebo daily with standard of care | Drug | Matching placebo pill daily |
Primary outcome
Proportion of eligible enrolled
Time frame: 3 years
The overall proportion of identified as potentially eligible/pre-screened patients who enroll in the trial
1 secondary outcome
Feasibility of data collection
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapagliflozin (10Mg Tab) along with standard medical therapy in people with Lupus Nephritis (LN), run by Brigham and Women's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen H Costenbader, MD, MPH ((617) 525-8785, kcostenbader@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of eligible enrolled (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.