이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2026년 6월 25일 업데이트: Mónica Vazquez-Del Mercado, Hospital Civil Juan I. Menchaca

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

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.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

상세 설명

**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.

연구 유형

중재적

등록 (추정된)

30

단계

  • 2 단계
  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 멕시코
    • Jalisco
      • Guadalajara, Jalisco, 멕시코, 44340
        • Nuevo Hospital Civil de Guadalajara "Dr. Juan I. Menchaca".

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: 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.
다른 이름들:
  • Dapagliflozin along with standard medical therapy in lupus nephritis
장치: 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.
간섭 없음: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
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).
기간: The monitoring of our overall objective will be evaluated one month and three months after the start of enlistment.

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.
The monitoring of our overall objective will be evaluated one month and three months after the start of enlistment.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hospital Civil Juan I. Menchaca

수사관

  • 연구 책임자: Mónica Vázquez-Del Mercado Espinosa, MD, PhD., Hospital Civil Juan I. Menchaca

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 5월 28일

기본 완료 (추정된)

2027년 1월 28일

연구 완료 (추정된)

2027년 2월 26일

연구 등록 날짜

최초 제출

2026년 6월 25일

QC 기준을 충족하는 최초 제출

2026년 6월 25일

처음 게시됨 (실제)

2026년 7월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 25일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CI/00055/2026

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 공유 기간

Start date: May 28, 2026. End date: February 26, 2027

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • ANALYTIC_CODE
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

예

미국에서 제조되어 미국에서 수출되는 제품

예

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다