Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Childhood-onset Lupus Nephritis Initial Glucocorticoid-dose Harmonization Trial (LIGHT Trial) (LIGHT)

17 de julho de 2026 atualizado por: Hongmei Song, Peking Union Medical College Hospital

Low- Versus High-Dose Initial Glucocorticoid Therapy for Childhood-Onset Proliferative Lupus Nephritis: a Multicenter Open-Label Noninferiority Randomized Controlled Trial

Childhood-onset systemic lupus erythematosus (cSLE) is a severe chronic autoimmune disease with a high burden of major-organ involvement. Lupus nephritis (LN) affects more than half of children with SLE, and proliferative LN-including class III, IV, III+V, and IV+V disease-is associated with acute kidney injury, progression to end-stage kidney disease, and poor long-term outcomes.

Glucocorticoids remain a cornerstone of induction therapy for proliferative LN. However, the optimal initial dose in children is uncertain. Although recent adult SLE and LN guidelines increasingly recommend lower-dose glucocorticoid regimens with rapid tapering, pediatric guidelines still commonly recommend high initial prednisone doses of 1.5-2.0 mg/kg/day. Adult trials and comparative observational studies suggest that lower-dose glucocorticoid regimens may preserve efficacy while reducing treatment-related toxicity.

Because cumulative glucocorticoid exposure in children may impair growth, development, psychosocial well-being, and medication adherence, this trial will compare low-dose versus high-dose initial glucocorticoid regimens for induction treatment of pediatric proliferative LN. The objective is to determine whether a lower-dose regimen is non-inferior in efficacy while reducing glucocorticoid-related adverse effects and improving quality of life.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

198

Estágio

  • Fase 4

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Recrutamento
        • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
        • Contato:
        • Investigador principal:
          • Hongmei Song, MD, PhD
      • Beijing, Beijing Municipality, China
        • Recrutamento
        • Beijing Children's Hospital, Capital Medical University
        • Contato:
          • Huawei Mao, MD, PhD
          • Número de telefone: 86-10-59616318
          • E-mail: maohwei@qq.com
        • Investigador principal:
          • Huawei Mao, MD, PhD
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • Ainda não está recrutando
        • Chidren's Hospital of Chongqing Medical University
        • Contato:
        • Investigador principal:
          • Xuemei Tang, MD
    • Guangdong
      • Shenzhen, Guangdong, China
        • Ainda não está recrutando
        • Shenzhen Children's Hospital
        • Contato:
        • Investigador principal:
          • Jun Yang, MD
    • Hunan
      • Changsha, Hunan, China
        • Ainda não está recrutando
        • The Second Xiangya Hospital of Central South University
        • Contato:
        • Investigador principal:
          • Xiaochuan Wu, MD
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Ainda não está recrutando
        • Children's Hospital of Nanjing Medical University
        • Contato:
        • Investigador principal:
          • Haiguo Yu, MD
    • Jilin
      • Changchun, Jilin, China
        • Ainda não está recrutando
        • Jilin University
        • Contato:
        • Investigador principal:
          • Sirui Yang, MD
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Ainda não está recrutando
        • Children's Hospital of Fudan University
        • Investigador principal:
          • Li SUN, MD
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • Age ≥6 years and <18 years, with body weight ≥20 kg
  • Meets the 2019 European League Against Rheumatism (EULAR) and American College of Rheumatology (ACR) classification criteria for Systemic Lupus Erythematosus (SLE)
  • Renal biopsy confirming Lupus Nephritis class III, IV, III+V, or IV+V according to the International Society of Nephrology / Renal Pathology Society (ISN/RPS) classification
  • At screening: 24-hour urinary protein ≥1.0 g (or ≥25 mg/kg), or urine protein-to-creatinine ratio (UPCR) ≥1.0 g/g
  • White blood cell count ≥3.0 × 10⁹/L and lymphocyte count ≥1.0 × 10⁹/L
  • No prior intravenous methylprednisolone pulse therapy before enrollment, and glucocorticoid exposure ≤2 weeks before enrollment, with a maximum prednisone-equivalent dose ≤30 mg/day (or ≤1 mg/kg/day)
  • Written informed consent obtained and good treatment compliance expected

Exclusion Criteria:

  • Uncertain diagnosis of SLE, genetically confirmed monogenic lupus, or a history of immunodeficiency
  • Severe infection, including hepatitis C, active hepatitis B, HIV infection, tuberculosis infection, severe fungal infection, etc.
  • Severe neuropsychiatric lupus
  • Peripheral blood hemoglobin <60 g/L, platelet count <10 × 10⁹/L, or concomitant aplastic anemia
  • Severe cardiac insufficiency (NYHA functional class ≥ II)
  • Severe pulmonary involvement, including pulmonary hemorrhage, respiratory failure, pulmonary embolism, or other conditions requiring respiratory support
  • Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m²
  • Severe gastrointestinal bleeding, pancreatitis, or hepatic lesions
  • Patients deemed by the investigator to be unsuitable for participation in this trial

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Control group (High-dose group)
Standard high-dose glucocorticoid therapy
Medicamento: High-dose prednisone

All participants will receive two courses of intravenous methylprednisolone pulse therapy (10-30 mg/kg/day for 3 consecutive days per course; maximum 500 mg/day). Participants will then be randomized in a 1:1 ratio to the two treatment groups.

In the standard-dose (control) group, oral prednisone will be initiated at 1.4-1.6 mg/kg/day (maximum 60 mg/day), followed by gradual tapering according to the predefined schedule. For participants weighing <40 kg, doses will be adjusted in proportion to body weight using the following formula: Individual dose = standard dose × body weight (kg) × 0.025.

All participants will receive background therapy with oral hydroxychloroquine, mycophenolate mofetil, and intravenous belimumab at standard doses.
Experimental: Intervention group (Low-dose group)
Low-dose glucocorticoid therapy
Medicamento: Low-dose prednisone

All participants will receive two courses of intravenous methylprednisolone pulse therapy (10-30 mg/kg/day for 3 consecutive days per course; maximum 500 mg/day). Participants will then be randomized in a 1:1 ratio to the two treatment groups.

Participants in the intervention group will receive oral prednisone at an initial dose of 0.6-0.8 mg/kg/day, with a maximum dose of 30 mg/day, followed by gradual tapering according to the predefined schedule. For participants weighing <40 kg, doses will be adjusted in proportion to body weight using the following formula: Individual dose = standard dose × body weight (kg) × 0.025. The estimated cumulative prednisone dose over 24 weeks will be approximately 50% of that in the control group.

All participants will receive background therapy with oral hydroxychloroquine, mycophenolate mofetil, and intravenous belimumab at standard doses.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Total Renal Response at Week 24
Prazo: Week 24

Total renal response (TRR) is defined as achievement of complete renal response (CRR), primary efficacy renal response (PERR), or partial renal response (PRR).

Complete renal response (CRR) is defined as meeting both of the following criteria:

  1. Proteinuria <0.5 g/1.73 m², or 24-hour urinary protein excretion <300 mg/m², or urine protein-to-creatinine ratio (UPCR) <0.5 g/g; and
  2. Estimated glomerular filtration rate (eGFR) within the normal range, or eGFR ≥85% of baseline, or a normal serum creatinine level with an increase of no more than 25% from baseline.

Primary efficacy renal response (PERR) is defined as meeting both of the following criteria:

  1. UPCR <0.7 g/g; and
  2. eGFR ≥80% of baseline or eGFR ≥60 mL/min/1.73 m².

Partial renal response (PRR) is defined as meeting both of the following criteria:

  1. A ≥50% reduction in proteinuria from baseline and UPCR <3 g/g; and
  2. eGFR ≥85% of baseline.
Week 24

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Complete Renal Response at Week 12 and 24
Prazo: Week 12, 24
CRR is defined as meeting both of the following criteria: (1) Urine protein <0.5 g/1.73 m², or 24-hour urine protein <300 mg/m², or urine protein-to-creatinine ratio (UPCR) <0.5 g/g; AND (2) Estimated glomerular filtration rate (eGFR) within the normal range; or eGFR at least 85% of baseline; or normal serum creatinine with an increase of no more than 25% from baseline.
Week 12, 24
Primary Efficacy Renal Response at Week 12 and 24
Prazo: Week 12, 24
PERR is defined as meeting both of the following criteria: (1) UPCR <0.7 g/g; AND (2) eGFR at least 80% of baseline or eGFR ≥60 mL/min/1.73 m².
Week 12, 24
Partial Renal Response at Week 12 and 24
Prazo: Week 12, 24
PRR is defined as meeting both of the following criteria: (1) Urine protein reduced by ≥50% from baseline and UPCR <3 g/g; AND (2) eGFR at least 85% of baseline.
Week 12, 24
Time to TRR
Prazo: Week 0-24
Total renal response (TRR) is defined as achievement of complete renal response (CRR), primary efficacy renal response (PERR), or partial renal response (PRR). Complete renal response (CRR) is defined as meeting both of the following criteria: 1. Proteinuria <0.5 g/1.73 m², or 24-hour urinary protein excretion <300 mg/m², or urine protein-to-creatinine ratio (UPCR) <0.5 g/g; and 2. Estimated glomerular filtration rate (eGFR) within the normal range, or eGFR ≥85% of baseline, or a normal serum creatinine level with an increase of no more than 25% from baseline. Primary efficacy renal response (PERR) is defined as meeting both of the following criteria: 1. UPCR <0.7 g/g; and 2. eGFR ≥80% of baseline or eGFR ≥60 mL/min/1.73 m². Partial renal response (PRR) is defined as meeting both of the following criteria: 1. A ≥50% reduction in proteinuria from baseline and UPCR <3 g/g; and 2. eGFR ≥85% of baseline.
Week 0-24
Time to CRR
Prazo: Week 0-24
Complete renal response (CRR) is defined as meeting both of the following criteria: (1) Urine protein <0.5 g/1.73 m², or 24-hour urine protein <300 mg/m², or urine protein-to-creatinine ratio (UPCR) <0.5 g/g; (2) Estimated glomerular filtration rate (eGFR) within the normal range; or eGFR at least 85% of baseline; or normal serum creatinine with an increase of no more than 25% from baseline.
Week 0-24
Time to PERR
Prazo: Week 0-24
Primary efficacy renal response (PERR) is defined as meeting both of the following criteria: (1) UPCR <0.7 g/g; (2) eGFR at least 80% of baseline or eGFR ≥60 mL/min/1.73 m².
Week 0-24
Time to PRR
Prazo: Week 0-24
Partial renal response (PRR) is defined as meeting both of the following criteria: (1) Urine protein reduced by ≥50% from baseline and UPCR <3 g/g; (2) eGFR at least 85% of baseline.
Week 0-24
Change of C3 from baseline to Week 24
Prazo: Week 0, 24
To assess the improvement of SLE serum activity
Week 0, 24
Changes of C4 from baseline to Week 24
Prazo: Week 0, 24
To assess the improvement of SLE serum activity
Week 0, 24
Change of anti-dsDNA titer from baseline to Week 24
Prazo: Week 0, 24
To assess the improvement of SLE disease activity
Week 0, 24
Change of anti-dsDNA value from baseline to Week 24
Prazo: Week 0, 24
To assess the improvement of SLE disease activity
Week 0, 24
Change of SLEDAI-2K from baseline to Week 24
Prazo: Week 0, 24
To assess the level of disease activity improvement by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score.
Week 0, 24
Change of PGA from baseline to Week 24
Prazo: Week 0, 24
Physician Global Assessment (PGA) is a clinical tool utilizing a 0 to 3 visual analogue scale to measure overall disease activity by experienced rheumatologists.
Week 0, 24
Change of ParentGA from baseline to Week 24
Prazo: Week 0, 24
Parental Global Assessment (ParentGA) is a parent-reported outcome measure used to quantify a caregiver's perception of their child's overall disease impact and well-being. ParentGA consists of a horizontal line containing 21 circles numbered from 0 to 10. The scale moves in 0.5 increments. The score of 0 indicates "very well" (best possible health status/disease activity) and 10 indicates "very poor" (worst possible health status/disease activity).
Week 0, 24
Change of PedsQL from baseline to Week 24
Prazo: Week 0, 24
The Pediatric Quality of Life Inventory (PedsQL) is a modular assessment tool used to measure health-related quality of life in children, evaluating physical, emotional, social, and school functioning to generate an overall health score.
Week 0, 24
Change of serum creatinine from baseline to Week 24
Prazo: Week 0, 24
To measure renal function levels
Week 0, 24
Change of eGFR from baseline to Week 24
Prazo: Week 0, 24

eGFR (estimated Glomerular Filtration Rate) is a calculated value used to assess kidney filtration function. Pediatric eGFR [mL/(min·1.73m2)] = K × 88.4 × Height (cm)/Serum Creatinine (μmol/L).

When serum creatinine is measured using the Jaffe method, the K coefficient is proportional to an individual's muscle mass and varies with age. In adolescents, it varies according to sex:

Children and adolescent females: K = 0.55; Adolescent males: K = 0.77. When creatinine is measured using an enzymatic assay: K = 0.413
Week 0, 24
Change of 24-hour urine protein from baseline to Week 24
Prazo: Week 0, 24
A 24-hour urine protein test measures kidney function by quantifying how much protein the body excretes in a full day.
Week 0, 24
Changes of UPCR from baseline to Week 24
Prazo: Week 0, 24
A UPCR (Urine Protein Creatinine Ratio) test measures the amount of protein relative to creatinine in a single urine sample. It is a highly accurate, convenient alternative to 24-hour urine test.
Week 0, 24
Rate of LN treatment failure at Week 24
Prazo: Week 24

LN treatment failure is defined as the occurrence of any of the following:

  1. Death;
  2. New-onset end-stage renal disease (ESRD), or the need for dialysis or kidney transplantation;
  3. Doubling of serum creatinine (compared with the baseline level);

  4. Renal flare, defined by either (a) or (b):

    1. Proteinuric flare: after excluding secondary causes such as infection, 24-hour urinary protein excretion or the urine protein-to-creatinine ratio (UPCR) increased to at least twice the baseline level; or

    2. Nephritic flare: after excluding secondary causes such as infection, serum creatinine increased by 25% from baseline, together with any of the following:

      • 24-hour urinary protein increased to at least twice the baseline level and exceeded 2 g/24 h, or the equivalent UPCR;
      • New-onset hematuria graded as 2+ or more;
      • New-onset cellular casts.
Week 24
Rate of renal flare at Week 24
Prazo: Week 24

Renal flare, defined by either (a) or (b):

  1. Proteinuric flare: after excluding secondary causes such as infection, 24-hour urinary protein excretion or the urine protein-to-creatinine ratio (UPCR) increased to at least twice the baseline level; or

  2. Nephritic flare: after excluding secondary causes such as infection, serum creatinine increased by 25% from baseline, together with any of the following:

    • 24-hour urinary protein increased to at least twice the baseline level and exceeded 2 g/24 h, or the equivalent UPCR;
    • New-onset hematuria graded as 2+ or more;
    • New-onset cellular casts.
Week 24
Rate of SLE flare at Week 24
Prazo: Week 24

SLE flare is defined according to SELENA-SLEDAI definitions:

  1. An increase in the SLEDAI score of ≥3 points compared with the previous assessment;
  2. New-onset or worsening manifestations of lupus activity, including cutaneous lesions, oral or nasal ulcers, pleuritis, pericarditis, arthritis, fever, neuropsychiatric lupus, vasculitis, nephritis, myositis, platelet count <60 × 10⁹/L, hemolytic anemia (hemoglobin <70 g/L or a decrease of >30 g/L), lupus myocarditis, or lupus pneumonitis;
  3. Initiation or dose escalation of medications because of disease activity, including NSAIDs, glucocorticoids, cyclophosphamide, methotrexate, or azathioprine;
  4. A Physician Global Assessment (PGA; range, 0-3) score of ≥1.
Week 24
Rate of LLDAS at Week 24
Prazo: Week 24

LLDAS was defined as meeting all of the following criteria:

  1. SLEDAI-2K score ≤4, with no activity in major organ systems (renal, neuropsychiatric, cardiopulmonary, vasculitic, or constitutional activity), no hemolytic anemia, and no gastrointestinal activity;
  2. No new manifestations of SLE disease activity compared with baseline;
  3. SELENA-SLEDAI Physician Global Assessment score (range, 0-3) ≤1;
  4. Prednisone dose, or equivalent glucocorticoid dose, ≤7.5 mg/day.
Week 24
Rate of DORIS remission at Week 24
Prazo: Week 24

DORIS remission is defined as meeting all of the following criteria:

  1. Clinical SLEDAI score = 0;
  2. Physician Global Assessment score (range, 0-3) <0.5, irrespective of serological activity;
  3. Treatment with antimalarial agents was permitted, as was prednisone at a dose of ≤5 mg/day (or an equivalent glucocorticoid dose) and/or stable immunosuppressive therapy, including biologic agents.
Week 24
PRINTO/ACR cSLE response rate at Week 24
Prazo: Week 24

Response was defined as improvement of at least 50% from baseline in any two of the five core outcome measures, with no more than one of the remaining measures worsening by more than 30%.

The five core outcome measures were Physician Global Assessment of overall disease activity (PGA), Parent Global Assessment of disease activity (ParentGA), proteinuria, the SLE Disease Activity Index 2000 (SLEDAI-2K), and the physical functioning domain of the Pediatric Quality of Life Inventory (PedsQL).
Week 24
Changes of Childhood Lupus Improvement Index (CHILI) from baseline to Week 24
Prazo: Week 0, 24
The Childhood Lupus Improvement Index (CHILI) is a validated measure of treatment response in childhood-onset SLE that primarily captures clinically meaningful improvement. The score is calculated using five core outcome measures: Physician Global Assessment of overall disease activity (PGA), Parent Global Assessment of disease activity (ParentGA), proteinuria assessed by the urine protein-to-creatinine ratio (UPCR) or 24-hour urinary protein excretion, the SLE Disease Activity Index 2000 (SLEDAI-2K), and the physical functioning domain of the Pediatric Quality of Life Inventory (PedsQL). (PMID: 30680946)
Week 0, 24
Rate of clinical, minor, moderate and major improvement in cSLE at Week 24
Prazo: Week 0, 24
Using the CHILI absolute-change definition, clinical improvement is defined as a CHILI score ≥54; minor improvement as CHILI ≥15; moderate improvement as CHILI ≥68; and major improvement as CHILI ≥92.
Week 0, 24
Scores and changes of pGTI from baseline to Week 12 and 24
Prazo: Week 0, 12, 24

The pediatric glucocorticoid toxicity index (pGTI) is a composite index including 10 glucocorticoid toxicity domains: body mass index, growth and development, glucose tolerance, lipid metabolism, systolic blood pressure, bone mineral density, glucocorticoid-induced myopathy, skin toxicity, neuropsychiatric effects, and infection.

(PMID: 35917759)
Week 0, 12, 24
SLICC/ACR Damage Index at Week 24
Prazo: Week 24
The Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SLICC/ACR Damage Index, SDI) is designed to assess cumulative, irreversible organ damage occurring since the onset of SLE. It encompasses 39 types of chronic, irreversible damage across 12 organ systems, irrespective of ongoing inflammatory disease activity. (PMID: 8607884)
Week 24
Category, incidence and severity of adverse events
Prazo: Week 0-24

Adverse events should be assessed at each study visit, including the event name, timing, management, severity, and outcome.

Adverse event grading:

Grade 1 (mild): Asymptomatic or mild symptoms; clinical or diagnostic findings only; no treatment required.

Grade 2 (moderate): Requires minor or local treatment and limits instrumental activities of daily living.

Grade 3 (severe): Medically significant but not immediately life-threatening; hospitalization may be required; limits self-care activities of daily living.

Grade 4 (life-threatening): Requires urgent intervention. Grade 5 (death): Death related to the adverse event.
Week 0-24
Change of blood pressure from baseline to Week 24
Prazo: Week 0, 24
To measure improvement of kidney function, and monitor the side effect by glucocorticoids.
Week 0, 24
Change of fasting blood glucose from baseline to Week 24
Prazo: Week 0, 24
To evaluate adverse events of glucocorticoids
Week 0, 24
Changes of serum triglycerides from baseline to Week 24
Prazo: Week 0, 24
To monitor adverse effects of glucocorticoids
Week 0, 24
Changes of height from baseline to Week 24
Prazo: Week 0, 24
To measure the growth velocity of children, and monitor the adverse events of glucocorticoids
Week 0, 24
Changes of bone marrow density from baseline to Week 24
Prazo: Week 0, 24
To monitor the side effects of glucocorticoids, bone mineral density (BMD) is measured by dual-energy X-ray absorptiometry (DXA) at the lumbar spine.
Week 0, 24

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Peking Union Medical College Hospital

Colaboradores

Children's Hospital of Fudan University
Beijing Children's Hospital
Second Xiangya Hospital of Central South University
Shenzhen Children's Hospital
Nanjing Children's Hospital
Children's Hospital of Chongqing Medical University
Jilin University

Investigadores

  • Investigador principal: Hongmei Song, MD, PhD, Peking Union Medical College

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de julho de 2026

Conclusão Primária (Estimado)

1 de setembro de 2028

Conclusão do estudo (Estimado)

1 de março de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

13 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de julho de 2026

Primeira postagem (Real)

22 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • K10405
  • 2025-PUMCH-C-047 (Número de outro subsídio/financiamento: National High Level Hospital Clinical Research Funding)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

For privacy concerns, individual participant data will not be shared. Summary data will be available with publication and upon reasonable request.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever