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PlainTrials
RecruitingPhase 4interventionalRules rewrite

Phase 4: testing Dapagliflozin (10Mg Tab) along with standard medical therapy for Lupus Nephritis (LN)

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.

Official registry: https://clinicaltrials.gov/study/NCT07323524 · Brigham and Women's Hospital · enrollment listed as 33

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Dapagliflozin (10Mg Tab) along with standard medical therapy, or Placebo. The registry lists allocation as randomized. Lupus nephritis is a chronic and life-threatening autoimmune cause of kidney disease that predominately impacts young people and can lead to kidney failure.

They plan to enroll about 33 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Dapagliflozin (10Mg Tab) along with standard medical therapy, Placebo

Primary outcome (registry wording): Proportion of eligible enrolled

Who it is for (from inclusion criteria)

  • Ages 18 Years to 70 Years
  • 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

Public study contact (from the registry)

Karen H Costenbader, MD, MPH

(617) 525-8785

kcostenbader@bwh.harvard.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

2 listed

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FAQ about this NCT record

Is NCT07323524 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07323524?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07323524?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary