EUCTR2021-005856-12-FI进行中（未招募）1 期
Monoclonal gammopathies of renal significance (MGRS) in Finland
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Males or females = 18 years of age
- •Subject has provided informed consent prior to initiation of the study or subject’s legally acceptable representative has provided informed consent prior to the study when the subject has any kind of condition that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent.
- •Renal biopsy confirmed MGRS-disease.
- •oRenal biopsy must not be older than 3 months before informed consent
- •oRenal transplant patients are allowed
- •Amount of proteinuria = 500 mg/24 h OR eGFR = 20 ml/min prior to the study
- •Previous anticlonal treatment is allowed if deemed ineffective (no formal time required)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •Myeloma or systemic AL amyloidosis (smoldering myeloma sized plasma cell clone is allowed when in association with a documented MGRS condition and AHL amyloidosis and AH amyloidosis are included),
- •Cancer that requires treatment,
- •MGRS related to B-cell malignant disorders,
- •Known HIV infection, active hepatitis C infection (subjects with hepatitis C that achieve a sustained virologic response after antiviral therapy are allowed), or hepatitis B infection (subjects with hepatitis B surface antigen or core antibody that achieve sustained virologic response (PCR negativity in HBVNh) with antiviral therapy are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on the study),
- •Pregnancy or breastfeeding,
- •No cyclophosphamide within 6 months of enrollment, or oral high-dose prednisone or equivalent within 6 weeks of enrollment;
- •prednisone or its equivalent at a dosage of =10 mg daily for a condition unrelated to MGRS (e.g. asthma or gout) allowed.
- •mycophenolate mofetil (MMF), calcineurin inhibitors (CNI) or azathioprine treated patients are eligible if proteinuria not improving or if kidney function declining despite treatment with these medications. Once therapy with daratumumab started, these medications need to be discontinued unless they are used as immunosuppressive medication due to renal transplantation.
- •In patients who previously received rituximab, reconstitution of B cells (CD19 normalized, Ly-B-CD19 lab.code 8329) required,
- •Inability to use daratumumab and to comply with the study protocol as assessed by treating nephrologist and/or hematologist (e.g. severe psychiatric illness, severe lung disease, known allergy to daratumumab)
研究者
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