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ACTIVE NOT RECRUITING

NCT07678203

PHASE1/PHASE2

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

Sponsor: Hospital Civil Juan I. Menchaca

View on ClinicalTrials.gov

Summary

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.

Official title: Dapagliflozin Reduces the Progression of Chronic Kidney Disease in Lupus Nephritis: Phase II Trial.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-05-28

Completion Date

2027-02-26

Last Updated

2026-07-01

Healthy Volunteers

Conditions

Lupus Nephritis (LN)Chronic Kidney Disease SGLT 2 Inhibitors Systemic Lupus Erythematosus

Interventions

DRUG

Dapagliflozin (10Mg Tab) along with standard medical therapy

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.

DEVICE

Proteinuria Quantification

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.

Inclusion Criteria: 1. Patients over 18 years of age. 2. Patients who agree to participate in the study after signing an informed consent form. 3. Patients who meet the classification criteria for systemic lupus erythematosus proposed by the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019. 4. Patients diagnosed with active lupus nephritis based on one or a combination of the following: \- Renal biopsy: based on a report of the following histological classes: I, II, III, IV, V, or mixed (combinations of the aforementioned classes), following the recommendations of the International Society of Nephrology/Renal Pathology Society classification for lupus nephritis and modified National Institutes of Health (ISN/RPS) 2018 (Appendix 1). -Clinical: diagnostic variables of renal domain activity according to the SELENA-SLEDAI or Mex-SLEDAI composite clinical criteria (Appendix 2), with proteinuria always estimated on more than two occasions. 5. Patients with proteinuria greater than 500 mg/dL per day, quantified by the protein/creatinine ratio in a single urine sample or by quantification of protein in a 24-hour urine collection. Exclusion Criteria: * 1\. Pacientes con diagnóstico por biopsia o a integración del clínico de nefritis lúpica con temporalidad mayor a 6 meses. 2\. Pacientes bajo tratamiento actual con algún inhibidor iSGLT2, sulfonilureas, bombas de infusión continua de insulina. 3\. Pacientes con contraindicación del uso de inhibidor SGLT2. (Estadio clínico de enfermedad renal crónica KDIGO IV o tasa de filtrado glomerular estimada \<20 ml/min, estado de deshidratación moderado a severo, sospecha de infección grave aguda, requerimiento de evento quirúrgico en días próximos. Infecciones del tracto urinario o genitales severas, recurrentes (\>3 eventos/año), o con uso de dispositivos urinarios permanentes. 4\. Pacientes en embarazo en curso, puerperio o lactancia. 5. Paciente con requerimiento de reanimación hídrica agresiva, uso de aminas vasoactivas, requerimiento de dispositivos de ventilación mecánica invasiva o de alto flujo, terapias de sustitución orgánica, falla orgánica múltiple, infección grave o complicada, o cualquier estado patológico que por criterio clínico se considere al paciente como crítico. 6\. Estado de acidosis metabólica (por gasometría venosa pH \<7.30) o sospecha de cetoacidosis euglucémica. 7\. Pacientes con diagnóstico previo de Diabetes Mellitus tipo 1, tipo 2 o con el reporte al tamizaje de HbA1c \> 6.5%, glucemia en ayuno ≥126 mg/dL o glucemia ≥200 mg/dL asociado a síntomas de hiperglucemia. 8\. TFGe \<20 mL/min o requerimiento de terapia de sustitución renal previa o inminente.

Locations (1)

Nuevo Hospital Civil de Guadalajara "Dr. Juan I. Menchaca".

Guadalajara, Jalisco, Mexico