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RecruitingPhase 4

Dapagliflozin in Active Lupus Nephritis

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests dapagliflozin against a placebo (a pill with no active drug), along with usual treatment. It is for adults ages 18–70 with recently active lupus nephritis, a kidney disease caused by lupus.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18–70 and meet the study’s rules for lupus, with class III, IV, and/or V lupus nephritis confirmed by a kidney tissue test.
  • Kidney disease started or flared in the past 6 months, with signs of active disease on a kidney tissue or urine test.
  • Taking usual medicines that lower immune system activity to treat active lupus kidney disease.
  • Used steroid medicines for active lupus kidney disease within the past 6 months, or are using them now.
  • Taking usual antimalarial medicines and RAAS blockers (medicines that help protect the kidneys), unless these are unsafe for you.
  • Have enough protein in your first morning urine to meet the study’s limits: at least 0.5 g/g of protein or 0.3 mg/g of albumin, a type of protein.
  • Able to understand the study and agree to take part.

Who can't join

  • Kidney filtering rate (GFR) below 25.
  • Sudden kidney injury when joining the study, with a rise of more than 50% in the blood waste marker creatinine within 90 days.
  • Type 1 diabetes or being underweight, with a body mass index (BMI) below 18.5.
  • Active cancer, an active infection, or repeated infections of the urinary tract or genitals.
  • Pregnant, planning pregnancy without using birth control, or unable to use birth control.
  • Taking a steroid dose higher than the equivalent of 1 mg of prednisone per kilogram of body weight each day.
  • Current or past use of medicines called SGLT2 inhibitors or GLP-1 receptor agonists.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (2)

MA