Dapagliflozin for Lupus Nephritis
(Dapa-Active LN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether dapagliflozin, a medication typically used for other kidney issues, can aid individuals with lupus nephritis, a serious kidney problem linked to lupus. Participants will receive either dapagliflozin or a placebo (a pill with no active medicine) alongside their usual treatment to assess any improvement in their condition. Ideal candidates have been managing active lupus nephritis for the past six months and are already on standard lupus treatments, such as immunosuppressants. As a Phase 4 trial, this research aims to determine how an already FDA-approved and effective treatment can benefit more patients with lupus nephritis.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications. However, you must be on a standard treatment for lupus nephritis, which includes certain immunosuppressants and other therapies.
What is the safety track record for dapagliflozin?
Research shows that dapagliflozin, a drug already used for other kidney problems, is being tested for lupus nephritis. Studies have found that it can lower protein levels in urine without major safety issues. However, some side effects have been reported. One study found that 50% of participants experienced side effects, and about 10.5% stopped taking the drug due to these issues. Despite some concerns, past research indicates that dapagliflozin is generally well-tolerated. These findings are important to consider when thinking about joining a clinical trial.12345
Why are researchers enthusiastic about this study treatment?
Dapagliflozin is unique because it offers a novel approach to treating lupus nephritis by targeting the kidneys differently than traditional treatments. Most standard treatments, like immunosuppressants and corticosteroids, focus on reducing immune system activity. However, dapagliflozin, originally used for diabetes, works by helping the kidneys remove excess glucose, which may also help reduce inflammation and preserve kidney function in lupus nephritis. Researchers are excited about this potential dual benefit, as it could lead to improved outcomes with fewer side effects compared to existing therapies.
What evidence suggests that dapagliflozin might be an effective treatment for lupus nephritis?
Research has shown that dapagliflozin, a type of medication, may help people with lupus nephritis by reducing the amount of protein in their urine. One study reported a significant 47.6% decrease in protein levels after six months of treatment. Another study found that individuals taking this medication had a lower risk of developing lupus nephritis and requiring dialysis. In this trial, participants will receive either dapagliflozin 10 mg daily or a matching placebo pill daily for 12 weeks. These findings suggest dapagliflozin might effectively manage kidney problems related to lupus nephritis.12346
Are You a Good Fit for This Trial?
This trial is for adults aged 18-70 with lupus nephritis, confirmed by kidney biopsy and certain lab tests. Participants must be on standard treatments for active lupus nephritis, including immunosuppressants and antimalarials, and have used steroids in the past 6 months. They should not join if they can't give informed consent or meet other specific health criteria.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive dapagliflozin 10 mg/day or placebo for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dapagliflozin
Trial Overview
The study is testing Dapagliflozin (a diabetes medication) to see if it helps people with early and active lupus nephritis when added to their usual medications. Patients will either get Dapagliflozin or a placebo without knowing which one they're taking.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
Subjects will receive masked dapagliflozin 10 mg daily for 12 weeks
Subjects will receive a matching placebo pill to take daily for 12 weeks
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
Massachusetts General Hospital
Collaborator
Citations
Efficacy and safety of dapagliflozin in inactive lupus nephritis
We demonstrate a significant reduction in residual proteinuria in patients with inactive LN with dapagliflozin without safety concerns.
Sodium-Glucose Cotransporter-2 Inhibitors and Nephritis ...
SGLT2i users had a significantly lower risk of lupus nephritis (AHR, 0.55; 95% CI, 0.40-0.77), dialysis (AHR, 0.29; 95% CI, 0.17-0.48), kidney ...
Safety and efficacy of the SGLT2 inhibitor dapagliflozin in ...
Lower urinary tract infection was observed in one (2.63%) patient. The secondary end points revealed no improvement of SLE Disease Activity ...
4.
renalandurologynews.com
renalandurologynews.com/news/lupus-nephritis-sglt2-inhibitor-therapy-benefit-risk/SGLT2 Inhibitor Therapy May Benefit Patients With Lupus ...
Dapagliflozin improved some metabolic parameters over 12 months in trial patients with lupus nephritis. ... dapagliflozin on metabolic outcomes ...
#426 Antiproteinuric effects of dapagliflozin in lupus nephritis
This preliminary analysis shows a significant reduction in the proteinuria of −47.6% in patients after 6 months of dapagliflozin as opposed to a ...
SGLT2 inhibitors offer 'survival benefits' in patients with lupus
Treatment with SGLT2 inhibitors was associated with decreased mortality but increased incidence of lupus nephritis.
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