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Zuberitamab in the First Episode of Paediatric Nephrotic Syndrome

2026年8月11日 更新者：Children's Hospital of Fudan University

Efficacy and Safety of Single-dose Zuberitamab in the Initial Episode of Paediatric Steroid-sensitive Nephrotic Syndrome: A Multicenter Randomized Controlled Trial

The goal of this clinical trial is to learn whether adding Zuberitamab to standard corticosteroid therapy can help prevent relapse in children and adolescents aged 1 to 18 years with newly diagnosed steroid-sensitive nephrotic syndrome (SSNS). It will also learn about the safety of Zuberitamab.

The main questions it aims to answer are:

  • Does Zuberitamab plus standard corticosteroid therapy prolong the time to first relapse compared with standard corticosteroid therapy alone?
  • What medical problems do participants experience during treatment?

Researchers will compare Zuberitamab plus standard corticosteroid therapy to standard corticosteroid therapy alone to see whether adding Zuberitamab improves disease control.

Participants will:

  • Receive standard corticosteroid treatment for approximately 12 weeks, with or without a single intravenous infusion of Zuberitamab after achieving remission
  • Take preventive antibiotics if they are in the Zuberitamab group
  • Test their urine daily at home using dipsticks and record results in a diary
  • Visit the clinic for regular checkups and blood and urine tests during follow-up for up to 12 months

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

Primary nephrotic syndrome (PNS) is the most common glomerular disease in children. Although 80-90% of affected children achieve complete remission after initial corticosteroid therapy and are classified as having steroid-sensitive nephrotic syndrome (SSNS), most experience disease relapse within the first year after onset. Approximately half subsequently develop frequently relapsing nephrotic syndrome (FRNS) or steroid-dependent nephrotic syndrome (SDNS), requiring prolonged exposure to corticosteroids and additional immunosuppressive agents. Recurrent relapses and long-term immunosuppressive treatment are associated with substantial morbidity, including infection, impaired growth and development, metabolic complications, nephrotoxicity, and reduced quality of life.

B-cell depletion therapy has emerged as an effective strategy for relapsing nephrotic syndrome. Rituximab, an anti-CD20 monoclonal antibody, has demonstrated the ability to reduce relapse rates and maintain remission in children with FRNS/SDNS, even after withdrawal of corticosteroids and other immunosuppressive agents. Based on accumulating evidence, rituximab has been incorporated into international treatment guidelines. Building upon extensive clinical experience with rituximab, our group initiated an investigator-sponsored multicenter study evaluating early rituximab treatment in children with newly diagnosed SSNS. Long-term follow-up from this study suggested potential benefits in preventing relapse and demonstrated an acceptable safety profile.

Zuberitamab is a next-generation anti-CD20 monoclonal antibody developed through molecular engineering of rituximab. Compared with rituximab, preclinical studies have demonstrated enhanced antibody-dependent cellular cytotoxicity (ADCC), a larger steady-state volume of distribution, and more sustained B-cell depletion. Zuberitamab was approved in China in 2023 for the treatment of CD20-positive diffuse large B-cell lymphoma. In addition, its use in kidney diseases has been reported in retrospective cohort studies and other early clinical experiences, including patients with membranous nephropathy. However, evidence regarding its efficacy and safety in glomerular diseases, particularly in paediatric nephrotic syndrome, remains limited.

Current treatment strategies for childhood nephrotic syndrome primarily focus on managing relapses after they occur rather than preventing them during the early phase of disease. Whether early intervention with a potent anti-CD20 monoclonal antibody can modify the disease course and reduce future relapses remains uncertain. This study is designed to evaluate the efficacy and safety of early Zuberitamab administration in combination with standard corticosteroid therapy in children with newly diagnosed steroid-sensitive nephrotic syndrome.

This is a multicenter, open-label, randomized controlled trial conducted across nine pediatric nephrology centers in China. Children with newly diagnosed steroid-sensitive nephrotic syndrome (SSNS) who achieve remission following standard corticosteroid treatment will be randomized at weeks 4-5 after remission to receive either Zuberitamab plus standard corticosteroid treatment or standard corticosteroid treatment alone. Participants will be followed prospectively for up to 12 months to assess disease relapse, cumulative corticosteroid exposure, safety outcomes, kidney function, and health-related quality of life.

The study aims to determine whether early addition of Zuberitamab at weeks 4-5 after remission, compared with standard corticosteroid treatment alone, can prolong time to first relapse within 12 months.

研究の種類

介入

入学 (推定)

120

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • 中国
      • Changsha、中国
        • Second Xiangya Hospital of Central South University
      • Guiyang、中国
        • Guiyang Maternal and Child Health Care Hospital
        • コンタクト：
          • Yuhong Li
      • Shanghai、中国
        • Shanghai Children's Medical Center
      • Shanghai、中国
        • Shanghai Children's Hospital
      • Shanghai、中国
        • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
      • Wuhan、中国
        • Wuhan Children's Hospital
      • Wuxi、中国
        • Wuxi Women's & Children's Hospital
      • Xiamen、中国
        • Xiamen Maternity & Child Care Hospital
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国
        • Children's Hospital of Fudan University
        • コンタクト：
          • Hong Xu

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Newly diagnosed steroid-sensitive nephrotic syndrome (SSNS) according to the 2023 IPNA criteria, who achieved complete remission after steroid induction therapy prior to study entry, defined as UPCR (based on first morning void or 24 h urine sample) <= 20 mg/mmol (0.2 mg/mg), or negative or trace dipstick on three or more consecutive days.
  • An estimated glomerular filtration rate >= 90 mL/min/ 1.73 m2 at study entry.
  • Peripheral blood CD20+ (detected as CD19+) cells >= 1% of total lymphocytes.
  • No use of other immunosuppressants within 3 months prior to study entry, other than steroids for nephrotic syndrome.

Exclusion Criteria:

  • Known etiology including congenital nephrotic syndrome, IgA nephropathy, Henoch-Schönlein purpura nephritis, lupus nephritis, or other secondary nephrotic syndromes.
  • Patients exhibiting any of the following abnormal clinical laboratory values: leukopenia (white blood cells <= 3.0 × 10^9/L), absolute neutrophil count < 1.5 × 10^9/L; moderate to severe anemia (hemoglobin < 9.0 g/dL); thrombocytopenia (platelet count < 100 × 10^12/L); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times the upper limit of normal; positive for any autoimmune markers (ANA, ENA, ANCA, etc.) or decreased complement C3 levels.
  • Evidence of the following infections: severe or opportunistic infection within the previous 6 months (active tuberculosis or history of tuberculosis or suspected tuberculosis; chronic active infections such as EBV, CMV; active hepatitis B presentation or history, or hepatitis C or hepatitis B virus carrier; HIV infection; or other active viral infections).
  • Receipt of live vaccine within one month prior to study entry.
  • History of previous use of biological agents.
  • Current examination suggestive of heart failure, severe arrhythmia, angina pectoris (CTCAE Grade 4), or uncontrolled blood pressure.
  • Severe diseases of vital organs such as the brain or liver, or suffering from hematological or endocrine system disorders.
  • Diagnosis of co-existing autoimmune diseases, primary immunodeficiency, or malignancy.
  • History of organ transplantation (excluding cornea and hair transplants).
  • Known allergy to methylprednisolone, Zuberitamab injection active ingredients or any excipients, sulfamethoxazole (or a contraindication to this drug due to G6PD deficiency).
  • Investigator's judgment that the patient is unsuitable for participation in this study (e.g., patient is highly likely to be lost to follow-up or provide false results, such as alcohol dependence or psychiatric illness).

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：Zuberitamab + Standard corticosteroid treatment
Zuberitamab plus standard corticosteroid treatment: Zuberitamab 375 mg/m2 (max 500 mg) as a single IV dose after remission. Premedication 30 min prior includes oral antipyretic and antihistamine and IV methylprednisolone 1.6 mg/kg (max 48 mg); oral steroid withheld on infusion day. Standard corticosteroid treatment consists of oral prednisone/prednisolone per protocol taper. TMP-SMZ prophylaxis (TMP 3 mg/kg on alternate days, max SMZ 960 mg) is administered until CD19 recovery. Relapse is managed per protocol with corticosteroid re-induction and possible repeat zuberitamab after remission. Permitted and prohibited concomitant medications are the same as in the comparator arm.
生物学的：Zuberitamab

Zuberitamab is administered as a single intravenous infusion at a dose of 375 mg/m² (maximum 500 mg) following achievement of steroid-sensitive remission.

To reduce the risk of infusion-related reactions, premedication is administered approximately 30 minutes before infusion and may include:

  • Acetaminophen or ibuprofen;
  • Cetirizine, cyproheptadine, loratadine, or equivalent antihistamines;
  • Intravenous methylprednisolone 1.6 mg/kg (maximum 48 mg).

Participants receiving zuberitamab also receive prophylactic trimethoprim-sulfamethoxazole (TMP 3 mg/kg every other day; maximum SMZ dose 960 mg every other day) until B-cell recovery.

Infusion-related reactions are managed according to protocol-defined procedures, including infusion rate reduction, temporary interruption, permanent discontinuation when clinically indicated, and appropriate supportive therapy.

他の名前：
  • Zuberitamab (BioRay Biopharmaceutical Co., Ltd.)
薬：standard corticosteroid treatment
standard corticosteroid treatment administered orally to treat steroid-sensitive nephrotic syndrome: 6 weeks at 2 mg/kg (max 60 mg/day), then alternate day steroid 1.5 mg/kg (max 40 mg on alternate days) for 6 weeks.
他の名前：
  • プレドニゾロン/プレドニゾン
アクティブコンパレータ：Standard corticosteroid treatment Only
Standard corticosteroid treatment: oral prednisone/prednisolone 2 mg/kg/day (max 60 mg) for 6 weeks, followed by 1.5 mg/kg (max 40 mg) on alternate days for 6 weeks, then discontinue. No zuberitamab, TMP-SMZ prophylaxis, or infusion premedication is given during initial treatment. Relapse is managed per protocol with corticosteroid re-induction; participants may receive zuberitamab after remission is re-achieved according to predefined criteria. Permitted concomitant medications include antihypertensives, calcium supplementation, anti-infective agents, antihistamines, anticoagulants, IVIG, hepatoprotective agents, glucose-lowering medications, and ophthalmic treatments. Prohibited therapies include other immunosuppressants (rituximab, CNIs, MMF, cyclophosphamide, plasma exchange) and Chinese herbal medicines for nephrotic syndrome (e.g., Huangkui, Huaiqihuang, Tripterygium). Live vaccines are prohibited during B-cell depletion.
薬：standard corticosteroid treatment
standard corticosteroid treatment administered orally to treat steroid-sensitive nephrotic syndrome: 6 weeks at 2 mg/kg (max 60 mg/day), then alternate day steroid 1.5 mg/kg (max 40 mg on alternate days) for 6 weeks.
他の名前：
  • プレドニゾロン/プレドニゾン

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Relapse-free survival time within 12 months after randomization
時間枠：From randomization until first relapse or 12 months after randomization, whichever occurs first.
Time from randomization to the first confirmed disease relapse during the 12-month follow-up period. Participants without relapse will be censored at the date of the last available assessment. Relapse is defined according to the 2023 International Pediatric Nephrology Association (IPNA) criteria as urine dipstick protein ≥3+ (≥300 mg/dL) or urine protein-to-creatinine ratio (UPCR) ≥200 mg/mmol (≥2 mg/mg) on a spot urine sample for three consecutive days, with or without edema, in a participant who previously achieved complete remission.
From randomization until first relapse or 12 months after randomization, whichever occurs first.

二次結果の測定

結果測定
メジャーの説明
時間枠
Relapse-Free Survival Rate at 12 Months Post-Randomization
時間枠：12 months post-randomization.
The proportion of participants who remain free from disease relapse at 12 months after randomization.
12 months post-randomization.
Relapse-Free Survival Rate at 6 Months Post-Randomization
時間枠：6 months post-randomization.
The proportion of participants who remain free from disease relapse at 6 months after randomization.
6 months post-randomization.
Cumulative Steroid Dose at 12 Months Post-Randomization
時間枠：12 months post-randomization.
The total amount of steroid medication (prednisolone) taken by participants from randomization until 12 months.
12 months post-randomization.
Change From Baseline in Serum Creatinine (Renal Function) at 12 Months
時間枠：From baseline to 12 months post-randomization.
Change from baseline in serum creatinine levels to assess renal function.
From baseline to 12 months post-randomization.
Change From Baseline in Serum Creatinine at the Time of Relapse
時間枠：From baseline to the date of documented disease relapse (up to 12 months).
Change from baseline in serum creatinine levels measured at the acute phase of disease relapse.
From baseline to the date of documented disease relapse (up to 12 months).
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at 12 Months
時間枠：From baseline to 12 months post-randomization
Change from baseline in eGFR, calculated using an appropriate pediatric formula (e.g., the modified Schwartz formula), to assess renal function.
From baseline to 12 months post-randomization
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at the Time of Relapse
時間枠：From baseline to the date of documented disease relapse (up to 12 months)
Change from baseline in eGFR at the acute phase of disease relapse.
From baseline to the date of documented disease relapse (up to 12 months)
Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Scores at 12 Months
時間枠：From baseline to 12 months post-randomization
Change from baseline in total and domain-specific scores (physical, emotional, social, and school functioning) using the PedsQL 4.0 Chinese Standard Version (30-day recall) and PedsQL Infant scales (13-24 months). Scores range from 0 to 100, with higher scores indicating better quality of life. Includes child self-report (ages 5-18) and parent proxy (ages 2-18 and infants).
From baseline to 12 months post-randomization
Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Scores at the Time of Relapse
時間枠：From baseline to the date of documented disease relapse (up to 12 months)
Change from baseline in PedsQL total and domain scores measured at the time of disease relapse. Scores range from 0 to 100, with higher scores indicating better quality of life.
From baseline to the date of documented disease relapse (up to 12 months)
Change From Baseline in Systolic Blood Pressure Z-scores at 12 Months
時間枠：From baseline to 12 months post-randomization
Change from baseline in systolic blood pressure, expressed as Z-scores relative to age-, sex-, and height-specific normative data.
From baseline to 12 months post-randomization
Change From Baseline in systolic Blood Pressure Z-scores at the Time of Relapse
時間枠：From baseline to the date of documented disease relapse (up to 12 months)
Change from baseline in systolic blood pressure, expressed as Z-scores relative to age-, sex-, and height-specific normative data.
From baseline to the date of documented disease relapse (up to 12 months)
Change From Baseline in diastolic Blood Pressure Z-scores at 12 Months
時間枠：From baseline to 12 months post-randomization
Change from baseline in diastolic blood pressure, expressed as Z-scores relative to age-, sex-, and height-specific normative data.
From baseline to 12 months post-randomization
Change From Baseline in diastolic Blood Pressure Z-scores at the Time of Relapse
時間枠：From baseline to the date of documented disease relapse (up to 12 months)
Change from baseline in diastolic blood pressure, expressed as Z-scores relative to age-, sex-, and height-specific normative data.
From baseline to the date of documented disease relapse (up to 12 months)
Change From Baseline in Height Z-scores at 12 Months
時間枠：From baseline to 12 months post-randomization
Change from baseline in height, expressed as Z-scores relative to age- and sex-specific normative growth charts.
From baseline to 12 months post-randomization
Change From Baseline in Height Z-scores at the Time of Relapse
時間枠：From baseline to the date of documented disease relapse (up to 12 months)
Change from baseline in height Z-scores at the acute phase of disease relapse.
From baseline to the date of documented disease relapse (up to 12 months)
Change From Baseline in Weight Z-scores at 12 Months
時間枠：From baseline to 12 months post-randomization
Change from baseline in weight, expressed as Z-scores relative to age- and sex-specific normative growth charts.
From baseline to 12 months post-randomization
Change From Baseline in Weight Z-scores at the Time of Relapse
時間枠：From baseline to the date of documented disease relapse (up to 12 months)
Change from baseline in weight Z-scores at the acute phase of disease relapse.
From baseline to the date of documented disease relapse (up to 12 months)
Change From Baseline in Laboratory Blood Parameters (Hemoglobin) at 12 Months
時間枠：From baseline to 12 months post-randomization
Change from baseline in hemoglobin levels.
From baseline to 12 months post-randomization
Change From Baseline in Laboratory Blood Parameters (Hemoglobin Levels) at the Time of Relapse
時間枠：From baseline to the date of documented disease relapse (up to 12 months)
Change from baseline in hemoglobin levels at the acute phase of disease relapse.
From baseline to the date of documented disease relapse (up to 12 months)
Change From Baseline in Laboratory Blood Parameters (Serum Albumin) at 12 Months
時間枠：From baseline to 12 months post-randomization
Change from baseline in serum albumin levels.
From baseline to 12 months post-randomization
Change From Baseline in Laboratory Blood Parameters (Serum Albumin) at the Time of Relapse
時間枠：From baseline to the date of documented disease relapse (up to 12 months)
Change from baseline in serum albumin levels at the acute phase of disease relapse.
From baseline to the date of documented disease relapse (up to 12 months)
Change From Baseline in Laboratory Blood Parameters (Total Cholesterol) at 12 Months
時間枠：From baseline to 12 months post-randomization
Measurement of total cholesterol concentration in blood.
From baseline to 12 months post-randomization
Change From Baseline in Laboratory Blood Parameters (Total Cholesterol) at the Time of Relapse
時間枠：From baseline to the date of documented disease relapse (up to 12 months)
Change from baseline in total cholesterol levels at the acute phase of disease relapse.
From baseline to the date of documented disease relapse (up to 12 months)
Time to CD19+ B-Cell Recovery
時間枠：From baseline to 12 months post-randomization
The time from CD19+ cell depletion until the first detection of CD19+ cells exceeding 1% of total CD45+ lymphocytes.
From baseline to 12 months post-randomization
T-cell Immunophenotyping
時間枠：Baseline, 1 month, 3 months, 6 months and 12 months after randomization.
Longitudinal assessment of peripheral blood T-cell subsets, including absolute counts and relative proportions of naïve T cells, central memory T cells, effector memory T cells, regulatory T cells, and other predefined T-cell populations measured by flow cytometry.
Baseline, 1 month, 3 months, 6 months and 12 months after randomization.
B-cell Immunophenotyping
時間枠：Baseline, 1 month, 3 months, 6 months and 12 months after randomization.
Longitudinal assessment of peripheral blood B-cell subsets, including absolute counts and relative proportions of naïve B cells, memory B cells, switched memory B cells, plasmablasts, CD19+ B cells, and other predefined B-cell populations measured by flow cytometry.
Baseline, 1 month, 3 months, 6 months and 12 months after randomization.
Cytokine Profiling
時間枠：Baseline, 1 month, 3 months, 6 months and 12 months after randomization.
Longitudinal assessment of serum cytokine and chemokine concentrations associated with immune regulation and relapse risk, including but not limited to IL-7, IL-9, IL-15, VEGF, TGF-β3, RANTES, IL-10, IL-6, IFN-γ, and IL-4.
Baseline, 1 month, 3 months, 6 months and 12 months after randomization.
Incidence and Severity of Adverse Events (AEs)
時間枠：From randomization through study completion, up to 12 months.
Monitoring and recording of the frequency and severity of adverse events, including infusion-related reactions (e.g., nausea, rash, fever, chills, bronchospasm, hypertension, hypotension), infections (e.g., respiratory, HBV reactivation, VZV, Pneumocystis carinii pneumonia), cardiac events (e.g., fulminant myocarditis, heart failure), interstitial lung disease, inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease), and abnormal laboratory findings (e.g., neutropenia, persistent hypogammaglobulinemia, elevated transaminases). Adverse events are graded according to NCI-CTCAE v5.0.
From randomization through study completion, up to 12 months.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Children's Hospital of Fudan University

協力者

Shanghai Children's Hospital
Shanghai Children's Medical Center
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Second Xiangya Hospital of Central South University
Xiamen Maternity & Child Care Hospital
Wuhan Children's Hospital
Guiyang Maternal and Child Health Care Hospital
Wuxi Women's & Children's Hospital

捜査官

  • 主任研究者：Hong Xu、Children's Hospital of Fudan University
  • 主任研究者：Qian Shen、Children's Hospital of Fudan University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月20日

一次修了 (推定)

2028年8月20日

研究の完了 (推定)

2028年12月31日

試験登録日

最初に提出

2026年6月8日

QC基準を満たした最初の提出物

2026年8月11日

最初の投稿 (実際)

2026年8月14日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月14日

QC基準を満たした最後の更新が送信されました

2026年8月11日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • HiFIRPedINS

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個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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