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.
\*\*Description of Procedures\*\* Participants who meet the inclusion and exclusion criteria and provide written informed consent will be randomly assigned in a 1:1 ratio to one of two study groups: standard treatment plus dapagliflozin 10 mg/day or standard treatment alone. Participants in the intervention group will receive a three-month supply of dapagliflozin (84 tablets). All participants will continue routine outpatient follow-up for a period of three months. The primary evaluation will include baseline and 3-month measurements of proteinuria (using either the urine protein-to-creatinine ratio in a spot urine sample or 24-hour urine protein quantification) and kidney function assessed by estimated glomerular filtration rate (eGFR). These laboratory tests are part of the standard clinical monitoring of patients with lupus nephritis. Renal response will be classified according to the KDIGO 2024 recommendations as complete remission, primary renal response, partial response, or no response, based on changes in proteinuria and kidney function during follow-up. Additionally, cardiovascular-kidney-metabolic health status will be assessed at baseline and at the end of the study using the 2023 American Heart Association classification, to determine improvement, stability, or progression of cardiovascular, renal, and metabolic risk. The use of other antiproteinuric medications will be allowed at the discretion of the treating physician, except for SGLT2 inhibitors in the control group. Adverse events and safety outcomes will be monitored throughout the study. If adverse effects or contraindications related to dapagliflozin occur, the medication will be discontinued and appropriate medical care will be provided.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
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.
Nuevo Hospital Civil de Guadalajara "Dr. Juan I. Menchaca".
Guadalajara, Jalisco, Mexico
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).
The following variables and definitions of remission in lupus nephritis will be reported: * Complete: Reduction of proteinuria to \<500 mg/dL. Stabilization or improvement of the estimated glomerular filtration rate (eGFR) (10-15% of baseline). * Primary renal response: Proteinuria \<700 mg/dL. No worsening of the eGFR \>20% of baseline or greater than 60 mL/min/1.73 m². No use of rescue therapy. * Partial: Reduction of proteinuria by at least 50% to \<3,000 g/dL and stabilization or improvement of the eGFR (10-15% of baseline). * No renal response: Failure to achieve any of the above definitions within 3 months.
Time frame: The monitoring of our overall objective will be evaluated one month and three months after the start of enlistment.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.