Dapagliflozin to Reduce the Decline in Renal Function in Patients Newly Diagnosed With Lupus Nephritis

Sponsor
Hospital Civil Juan I. Menchaca
Study ID
NCT07678203
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin (10Mg Tab) along with standard medical therapy — DRUG
    Participants in the experimental group will receive a 3-month supply of dapagliflozin 10 mg/day. During follow-up, baseline measurements of lupus nephritis activity, proteinuria, eGFR, and safety will be assessed at baseline, 1 month, and 3 months.
  • Proteinuria Quantification — DEVICE
    Estimación de los niveles de proteinuria por el índice proteínas/creatinina en muestra única de orina o la cuantificación de proteínas en muestra de orina de 24 horas según corresponda, así como la tasa de filtrado glomerular estimada.

Study Details

Lupus nephritis is one of the most serious complications of lupus, an autoimmune disease in which the immune system mistakenly attacks the body's own tissues. This condition causes inflammation and damage to the kidneys and is a major cause of chronic kidney disease, especially in the Latin American population. In these patients, the disease often appears at a younger age, presents with more intense inflammation, and has a more aggressive course. Although treatments exist that help control the immune response and reduce kidney damage, a significant proportion of patients do not achieve sustained kidney recovery. As a result, protein loss in the urine persists, and kidney function continues to deteriorate over time. Given this situation, new therapeutic alternatives have emerged aimed at protecting kidney function. Among them is dapagliflozin, a medication that has shown benefits in various types of chronic kidney disease by helping to lower pressure within the kidneys, reduce inflammation, and limit the formation of scar tissue. However, there is still limited information on its effectiveness in people with active lupus nephritis. The objective of this study is to evaluate the efficacy and safety of dapagliflozin in preventing the progression of chronic kidney disease in patients with lupus nephritis. The results will generate scientific evidence to help improve renal protection strategies in this population. To this end, a phase II, open-label, controlled, randomized clinical trial will be conducted in adult patients newly diagnosed with lupus nephritis treated at the Nuevo Hospital Civil de Guadalajara "Dr. Juan I. Menchaca". Participants will be randomly assigned in a one-to-one ratio to two groups: one will receive standard treatment plus dapagliflozin (10 mg daily), and the other will receive only standard treatment. For three months, the amount of protein excreted in urine, renal function, and progression to chronic kidney disease will be evaluated. In addition, potential adverse effects, changes in lupus activity, and variables related to the prevention of cardiovascular, renal, and metabolic diseases will be recorded.

Key Dates

First listed
Jul 1, 2026
Start date
May 28, 2026
Status verified
May 2026
Primary completion
Jan 28, 2027
Completion
Feb 26, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin Group
    Participants in the experimental group will receive a 3-month supply of dapagliflozin 10 mg/day. During follow-up, primary outcomes will be monitored, including baseline measurements, measurements at 1 month, and measurements at 3 months. Proteinuria levels, assessed by the urine protein-to-creatinine ratio in a single urine sample or by 24-hour urine protein excretion, and the estimated glomerular filtration rate will be obtained during outpatient visits.
  • No Intervention: Monitoring Group
    The follow-up group will receive only standard medical treatment. During their follow-up, baseline values for lupus nephritis activity, proteinuria, estimated glomerular filtration rate, and safety will be assessed at the start of the study, at one month, and at three months.

Primary Outcome Measure

Definition of renal remission in lupus nephritis proposed by the KDIGO 2024 guideline (Kidney Disease: Improving Global Outcomes, Clinical practice guideline for the management of lupus nephritis). [ Time Frame: The monitoring of our overall objective will be evaluated one month and three months after the start of enlistment. ]

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