CD38 mAb Induction + Azathioprine Maintenance for Chronic Active AMR in Kidney Transplant Recipients (CAZA)
16 июля 2026 г. обновлено: wujianyong
A Multicenter Exploratory Clinical Study of Targeted NK Cell Inhibition for Transplant Kidney Chronic Active Antibody-Mediated Rejection (caABMR): Single Induction With CD38 Monoclonal Antibody Followed by Sequential Maintenance With Azathioprine
This multicenter, prospective, single-arm exploratory study evaluates the efficacy and safety of a novel sequential regimen for chronic active antibody-mediated rejection (caABMR) in kidney transplant recipients: single-dose CD38 monoclonal antibody (1800 mg subcutaneous) induction to deplete plasma cells and NK cells, followed by long-term maintenance with azathioprine (replacing mycophenolate mofetil) plus standard triple immunosuppression (steroid + calcineurin inhibitor).
The regimen aims to control DSA-driven injury, stabilize or improve graft function (primary: eGFR decline slope), reduce DSA, improve pathology (Banff 2022), and minimize infection/nephrotoxicity risks associated with intensified or prolonged biologic therapy.
Twenty patients across 6 Chinese transplant centers will be enrolled.
CD38 mAb, azathioprine, key monitoring tests (HLA antibody, pharmacogenomics, immune profiling) are provided free by the study team (~40,000 RMB per patient).
Ethics approved; informed consent obtained.
Обзор исследования
Статус
Статус
Еще не набирают
Условия
Условия
Вмешательство/лечение
Вмешательство/лечение
Подробное описание
Background: caABMR is the leading cause of late kidney allograft loss. Current therapies (plasmapheresis, IVIG, rituximab, bortezomib, long-term CD38 mAb) have limited efficacy, high recurrence, significant side effects, and high cost with no approved standard.
Rationale: CD38 mAb depletes antibody-producing plasma cells and pathogenic NK cells, rapidly lowering DSA and micro vascular inflammation. However, long-term monotherapy is costly and may increase infection risk. This study uses single induction dose + switch to azathioprine (safe, inexpensive, long-used in transplantation, suppresses NK activity) for durable, affordable maintenance. TPMT/NUDT15 genotyping guides personalized AZA dosing; serial NK cell monitoring targets <20/μL.
Design: Multicenter (6 centers), prospective, open-label, single-arm, exploratory (N=20).
Intervention: Baseline: CD38 mAb 1800 mg SC x1 + immediate switch MMF→AZA (dose per genotype: normal metabolizer 2-3 mg/kg/d; intermediate 0.6-2.4 mg/kg/d). Maintain triple IS (steroid + AZA + Tac target 5-7 ng/mL or CsA 150-250 ng/mL).
Тип исследования
Тип исследования
Интервенционный
Регистрация (Оцененный)
Регистрация
20
Фаза
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
Контакты исследования
- Имя: Chunchun Wei, MD
- Номер телефона: +8613738053172
- Электронная почта: 327530957@qq.com
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
Inclusion Criteria:
- Voluntary written informed consent.
- Age ≥18 years.
- Kidney transplant (living or deceased donor) ≥180 days prior.
- eGFR ≥30 mL/min/1.73 m² (CKD-EPI 2021).
- Currently on stable triple immunosuppression (CNI + MMF + steroid) for ≥4 weeks, no severe related adverse effects.
- Positive HLA Class I and/or Class II donor-specific antibodies (DSA).
- Transplant kidney biopsy meeting Banff 2022 criteria for chronic active antibody-mediated rejection (caABMR).
- TPMT/NUDT15 genotyping: non-homozygous mutant (normal or intermediate metabolizer).
Exclusion Criteria:
- Participating in another clinical trial.
- Age <18 years.
- Pregnant, breastfeeding, or inadequate contraception in females.
- ABO-incompatible transplant.
- TPMT/NUDT15 homozygous mutant genotype.
- Biopsy shows any of: T-cell mediated rejection (TCMR), new/recurrent severe thrombotic microangiopathy, or polyomavirus nephropathy.
- Received anti-rejection therapy in prior 3 months.
- Received other immunomodulatory monoclonal/polyclonal antibodies (anti-CD20, bortezomib, anti-C5, anti-IL-6/IL-6R) in prior 3 months.
- Total bilirubin >2×ULN or ALT/AST >2.5×ULN.
- Hemoglobin <8 g/dL.
- Platelets <100×10^9/L.
- WBC <3×10^9/L or neutrophils <1.5×10^9/L.
- Hypogammaglobulinemia: IgG <400 mg/dL.
- Active bacterial, viral, or fungal infection.
- Active malignancy requiring intensified immunosuppression.
- Latent or active tuberculosis.
- Live vaccine within 6 weeks of screening.
- History of alcohol or illicit drug abuse.
- Severe medical or psychiatric illness likely to impair study participation.
- Active hepatitis B.
- Known hypersensitivity to CD38 mAb, azathioprine, or study drug components, or severe drug allergy history.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Количество рук
1
Оружие и интервенции
Группа участников / АрмияГруппа участников / Армия |
Вмешательство/лечениеВмешательство/лечение |
|---|---|
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Экспериментальный: Experimental: CD38 mAb Induction + Azathioprine Sequential Maintenance
All enrolled caABMR patients receive:
|
Single 1800 mg subcutaneous injection at baseline to induce rapid depletion of plasma cells (source of DSA) and NK cells (key effectors of microvascular injury in caABMR).
Marketed anti-CD38 mAb (off-label use in this indication).
Другие имена:
Oral azathioprine maintenance (replaces mycophenolate), individualized starting dose 2.0-3.0 mg/kg/day (normal TPMT/NUDT15 metabolizer) or 30-80% reduced (intermediate metabolizer), titrated per serial NK cell counts and hematologic tolerance.
Long-term NK suppression to maintain immune balance and protect graft.
Другие имена:
Continued per local practice with protocol targets
|
Что измеряет исследование?
Первичные показатели результатов
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Slope of estimated glomerular filtration rate (eGFR) decline
Временное ограничение: Baseline through Week 28, planned assessments at weeks 0, 4, 8, 12, 16, 20, 24, 28
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The primary efficacy endpoint is the slope of eGFR decline over 28 weeks, calculated from serial serum creatinine measurements (every 4 weeks) using the 2021 CKD-EPI equation.
Serum creatinine is measured by enzymatic method or isotope dilution mass spectrometry.
Slope is estimated via linear mixed-effects model or ordinary least-squares regression per patient, then summarized.
Negative slope indicates ongoing graft loss; less negative or positive slope indicates stabilization or improvement of renal function after treatment.
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Baseline through Week 28, planned assessments at weeks 0, 4, 8, 12, 16, 20, 24, 28
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Вторичные показатели результатов
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in peripheral blood NK cell, T cell and B cell subset counts and percentages measured by flow cytometry
Временное ограничение: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28
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Quantitative detection of lymphocyte subpopulations (NK, T, B cells) in peripheral blood via flow cytometry; evaluate the absolute count and relative percentage changes at each follow-up time point.
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Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28
|
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Absolute and relative percentage change in estimated glomerular filtration rate calculated by CKD-EPI 2021 formula
Временное ограничение: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28
|
Estimated glomerular filtration rate (eGFR) is calculated by the CKD-EPI 2021 formula.
Both absolute value and relative percentage change of eGFR will be evaluated at all scheduled follow-up visits.
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Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28
|
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Percentage change in urine protein-to-creatinine ratio (UPCR)
Временное ограничение: Baseline and Week 28
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Urine protein-to-creatinine ratio (UPCR) measured in mg/g or mg/mmol.
Urine protein is tested via pyrogallol red molybdate method, and creatinine is detected using sarcosine oxidase assay.
The relative percentage change of UPCR is used to evaluate renal therapeutic efficacy.
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Baseline and Week 28
|
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Relative percentage change in donor-specific antibody (DSA) mean fluorescence intensity (MFI)
Временное ограничение: Baseline, Week 8, Week 28
|
Donor-specific antibody MFI is detected via Luminex single-antigen bead assay.
Relative percentage change from baseline will be calculated to evaluate the reduction of alloantibody levels.
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Baseline, Week 8, Week 28
|
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Change in Transplant Kidney Biopsy Pathology Scores (Banff 2022)
Временное ограничение: Baseline, Week 28
|
Banff 2022 renal allograft pathology scoring system is applied for the interpretation of protocol kidney biopsy specimens.
The scores include microcirculation inflammation, tubulitis, interstitial inflammation, chronic glomerulopathy, transplant glomerulitis and chronic arteriopathy.
The pathological scores are recorded at screening baseline and week-28 follow-up biopsy.
The variation of each individual Banff lesion score between two time-points will be analyzed.
Higher Banff lesion scores represent more severe renal allograft injury.
|
Baseline, Week 28
|
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Incidence of Acute Rejection (TCMR, AMR, or Mixed)
Временное ограничение: Through Week 28
|
Cumulative incidence (%) of biopsy-proven acute rejection, including T cell-mediated rejection (TCMR), antibody-mediated rejection (AMR), and mixed rejection, diagnosed according to Banff 2022 classification criteria.
|
Through Week 28
|
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Patient overall survival rate
Временное ограничение: Week 28
|
The proportion of subjects who remain alive without all-cause mortality at the designated follow-up time point
|
Week 28
|
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Graft survival rate
Временное ограничение: Week 28
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Percentage of participants with functioning renal allograft, defined as no return to maintenance dialysis and no secondary kidney retransplantation
|
Week 28
|
|
Incidence of BK Virus (BKV) Infection
Временное ограничение: Through Week 28
|
Cases of BK virus infection are categorized as BKV viruria (>10³ copies/mL), BKV viremia (≥10⁴ copies/mL), or biopsy-confirmed BKV nephropathy identified by renal histology combined with SV40 IHC or ISH staining.
Cumulative incidence percentage will be calculated for each category.
|
Through Week 28
|
|
Incidence of Cytomegalovirus (CMV) Infection
Временное ограничение: Through Week 28
|
Cytomegalovirus infection is defined as detectable CMV DNA ≥10³ copies/mL quantified via quantitative PCR (qPCR).
Cumulative incidence percentage of affected subjects will be summarized.
|
Through Week 28
|
|
Incidence of Neutropenia
Временное ограничение: Through Week 28
|
Neutropenia is stratified by absolute neutrophil count (ANC): mild ANC <1.5×10⁹/L, moderate ANC <1.0×10⁹/L, severe ANC <0.5×10⁹/L.
Cumulative incidence percentage will be stratified by severity grades defined per NCI CTCAE or study protocol criteria.
|
Through Week 28
|
Другие показатели результатов
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Outcome Measure Title：Incidence of injection-related adverse reactions
Временное ограничение: Through Week 28
|
All infusion-related adverse events during the whole follow-up period will be recorded, including fever, chills, hypotension, dyspnea and other infusion-associated manifestations.
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Through Week 28
|
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Incidence of adverse events (AE) and serious adverse events (SAE)
Временное ограничение: Through Week 28
|
The type, severity, relation to study medication and occurrence frequency of all adverse events and serious adverse events will be collected, according to CTCAE common terminology criteria.
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Through Week 28
|
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Incidence of liver function abnormalities
Временное ограничение: Through Week 28
|
Liver function indexes including alanine transaminase, aspartate transaminase, total bilirubin will be tested regularly.
Liver function abnormality is defined as laboratory elevation exceeding 3-fold upper limit of normal range.
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Through Week 28
|
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Incidence of all-cause hospitalization
Временное ограничение: Through Week 28
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All hospitalization events for any reason during follow-up will be documented, including the admission time, diagnosis and length of hospital stay.
|
Through Week 28
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Спонсор
Следователи
Следователи
- Главный следователь: Jianyong Wu, MD, Zhejiang University
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
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Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
Начало исследования
15 июля 2026 г.
Первичное завершение (Оцененный)
Первичное завершение
15 марта 2028 г.
Завершение исследования (Оцененный)
Завершение исследования
15 марта 2028 г.
Даты регистрации исследования
Первый отправленный
Первый отправленный
11 июля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
Впервые представлено, что соответствует критериям контроля качества
16 июля 2026 г.
Первый опубликованный (Действительный)
Первый опубликованный
21 июля 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее опубликованное обновление
21 июля 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
Последнее отправленное обновление, отвечающее критериям контроля качества
16 июля 2026 г.
Последняя проверка
Последняя проверка
1 июля 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
Другие идентификационные номера исследования
- IIT20260074C-R1
Планирование данных отдельных участников (IPD)
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НЕТ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .