Who is eligible for clinical trial NCT07678203?

Participants must meet the protocol's inclusion criteria for Lupus Nephritis (LN). The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT07678203 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-06-25

Dapagliflozin to Reduce the Decline in Renal Function in Patients Newly Diagnosed With Lupus Nephritis (NCT07678203)

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

🔵 Active, Not Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: Hospital Civil Juan I. Menchaca

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (2 items).

Location: Nuevo Hospital Civil de Guadalajara "Dr. Juan I. Menchaca". — Guadalajara, Jalisco

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Patients over 18 years of age.
Patients who agree to participate in the study after signing an informed consent form.
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.
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.
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.

Usually NOT eligible if any of the following apply:

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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Nuevo Hospital Civil de Guadalajara "Dr. Juan I. Menchaca". — Guadalajara, Jalisco

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Lupus Nephritis (LN)

Dose Escalation Study With Bispecific Antibodies in Adult Participants With Lupus Nephritis — Rochester, Minnesota
Safety and Efficacy of ONT01 in Lupus — New York, New York
Dapagliflozin in Active Lupus Nephritis — Boston, Massachusetts

Explore by condition: All Lupus Nephritis (LN) clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Review the official NIH record below to find the coordinating site.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗