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

2026년 7월 17일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

198

단계

  • 4단계

연락처 및 위치

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

연구 연락처

연구 장소

  • 중국
    • Beijing Municipality
      • Beijing, Beijing Municipality, 중국, 100730
        • 모병
        • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
        • 연락하다:
        • 수석 연구원:
          • Hongmei Song, MD, PhD
      • Beijing, Beijing Municipality, 중국
        • 모병
        • Beijing Children's Hospital, Capital Medical University
        • 연락하다:
          • Huawei Mao, MD, PhD
          • 전화번호: 86-10-59616318
          • 이메일: maohwei@qq.com
        • 수석 연구원:
          • Huawei Mao, MD, PhD
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, 중국
        • 아직 모집하지 않음
        • Chidren's Hospital of Chongqing Medical University
        • 연락하다:
        • 수석 연구원:
          • Xuemei Tang, MD
    • Guangdong
      • Shenzhen, Guangdong, 중국
        • 아직 모집하지 않음
        • Shenzhen Children's Hospital
        • 연락하다:
        • 수석 연구원:
          • Jun Yang, MD
    • Hunan
      • Changsha, Hunan, 중국
        • 아직 모집하지 않음
        • The Second Xiangya Hospital of Central South University
        • 연락하다:
        • 수석 연구원:
          • Xiaochuan Wu, MD
    • Jiangsu
      • Nanjing, Jiangsu, 중국
        • 아직 모집하지 않음
        • Children's Hospital of Nanjing Medical University
        • 연락하다:
        • 수석 연구원:
          • Haiguo Yu, MD
    • Jilin
      • Changchun, Jilin, 중국
        • 아직 모집하지 않음
        • Jilin University
        • 연락하다:
        • 수석 연구원:
          • Sirui Yang, MD
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, 중국
        • 아직 모집하지 않음
        • Children's Hospital of Fudan University
        • 수석 연구원:
          • Li SUN, MD
        • 연락하다:

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

  • 어린이
  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

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

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
활성 비교기: Control group (High-dose group)
Standard high-dose glucocorticoid therapy
의약품: 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.
실험적: Intervention group (Low-dose group)
Low-dose glucocorticoid therapy
의약품: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Total Renal Response at Week 24
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Complete Renal Response at Week 12 and 24
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Week 0, 24
To assess the improvement of SLE serum activity
Week 0, 24
Changes of C4 from baseline to Week 24
기간: Week 0, 24
To assess the improvement of SLE serum activity
Week 0, 24
Change of anti-dsDNA titer from baseline to Week 24
기간: Week 0, 24
To assess the improvement of SLE disease activity
Week 0, 24
Change of anti-dsDNA value from baseline to Week 24
기간: Week 0, 24
To assess the improvement of SLE disease activity
Week 0, 24
Change of SLEDAI-2K from baseline to Week 24
기간: 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
기간: 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
기간: 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
기간: 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
기간: Week 0, 24
To measure renal function levels
Week 0, 24
Change of eGFR from baseline to Week 24
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Week 0, 24
To evaluate adverse events of glucocorticoids
Week 0, 24
Changes of serum triglycerides from baseline to Week 24
기간: Week 0, 24
To monitor adverse effects of glucocorticoids
Week 0, 24
Changes of height from baseline to Week 24
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Peking Union Medical College Hospital

협력자

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

수사관

  • 수석 연구원: Hongmei Song, MD, PhD, Peking Union Medical College

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

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 (추정된)

2026년 7월 1일

기본 완료 (추정된)

2028년 9월 1일

연구 완료 (추정된)

2029년 3월 1일

연구 등록 날짜

최초 제출

2026년 7월 13일

QC 기준을 충족하는 최초 제출

2026년 7월 17일

처음 게시됨 (실제)

2026년 7월 22일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 17일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • K10405
  • 2025-PUMCH-C-047 (기타 보조금/기금 번호: National High Level Hospital Clinical Research Funding)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

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미국 FDA 규제 기기 제품 연구

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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. .

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