Could a diabetes drug shield kidneys from lupus damage?
NCT ID NCT07678203
First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether dapagliflozin, a drug already used for diabetes and chronic kidney disease, can slow kidney damage in people with lupus nephritis. Lupus nephritis is a serious complication of lupus that causes kidney inflammation and can lead to chronic kidney disease. The study will randomly assign 30 adults with newly diagnosed lupus nephritis to receive either standard treatment alone or standard treatment plus dapagliflozin for three months, measuring changes in protein in the urine and kidney function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dapagliflozin
- What this could lead to
- If it works, this could point toward a new way to protect kidney function in people with lupus nephritis, potentially slowing or preventing chronic kidney disease.
- What could go wrong
- This is a small, early-phase trial with only 30 participants over 3 months. The results may not apply to all patients, and dapagliflozin may not prove effective or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Nuevo Hospital Civil de Guadalajara "Dr. Juan I. Menchaca".
Guadalajara, Jalisco, 44340, Mexico
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Other studies related to the condition(s) this trial covers.
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