2025-523306-33-00招募中2 期
Obinutuzumab Treatment in Frequently Relapsing and Rituximab-Dependent Idiopathic Nephrotic Syndrome in Adults: a fully academic, single-arm, open, prospective, intervention trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of participants who are relapse-free for 12 months after Obinutuzumab treatment
研究概览
简要总结
To evaluate the proportion of participants who are relapse-free for at least 12 months after obinutuzumab treatment*, administered as soon as remission is achieved by steroid treatment according to center practice. *in participant who relapsed within 12 month after rituximab prophylactic treatment withdrawal
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Adult age (≥18 years old)
- •Rituximab-dependent idiopathic nephrotic syndrome is defined and confirmed as: ● Availability of a recent (over the last 5 years) diagnostic kidney biopsy to confirm the diagnosis of MCD, FSGS or IgM glomerulonephritis and quantify the severity of chronic changes ● Previous history of multi-relapsing, steroid-dependent nephrotic syndrome ● Previous history (previous to start of the prophylactic protocol) of at least one relapse of the nephrotic syndrome after initial complete or partial remission and further remission achieved by steroid ● Relapse of the nephrotic syndrome within 12 months after withdrawal of rituximab prophylactic treatment defined as protein increase to >3.5g/24H P/C>3500 mg/g along with serum albumin <3.5 g/dl
- •Estimated GFR by the CKD-Epi creatinine equation (2021) ≥30 ml/min/1.73 m2
- •Ability to understand and provide a valid written consent to the study according to the guidelines of the Declaration of Helsinki and Good Clinical Practice
- •Compliance with an effective contraception without interruption, from 28 days before treatment start up to 18 months after treatment discontinuation, agreeing not to donate semen during treatment and for 18 months after discontinuation (if the participant is male). Furthermore, women should be advised to discontinue nursing during obinutuzumab therapy and for 18 months after the last dose of Obinutuzumab. (Please see the attached 2020 CTFG “Recommendations related to contraception and pregnancy testing in clinical trials”). Each female participant will undergo pregnancy test during the course of the study at fixed timepoints
排除标准
- •Concomitance of clinical conditions that could jeopardize completion of the treatment/observation period and/or confound data interpretation including: ● Active or recent (< 5 years before enrolment) history of malignancy; ● Other active systemic immune diseases requiring concomitant treatment with steroids or any other immunosuppressive agent; ● Severe/unstable heart failure requiring hospitalization or changes in pharmacological therapy; ● Refractory severe hypertension (BP >180/100 mmHg despite optimized pharmacological treatment with at least three blood pressure-lowering medications); ● Recent (within the last 4 weeks) severe infections requiring hospitalization or intravenous antibiotics;Known human immunodeficiency virus infection; ● Participants with previous hepatitis B virus infection who are seropositive for anti-HBcAb or subjects who are not immunized against HBV and subjects who are ABsAg-positive or anti-HBcAb positive alone. Subjects with both anti-HBsAb and anti-HBcAb (a condition that may reflect naturally cured infection) are eligible; ● Patients with untreated or not fully cured HCV infection; ● Planning a vaccination with live virus vaccines; ● Active bacterial, viral and/or fungal infections; ● Drug or alcohol abuse.
- •Pregnancy, lactation, or intention to become pregnant before or during the study period, or up to 18 months of the last dose of study treatment
- •Intention to donate ova or sperm over the same time period
- •Childbearing potential without highly effective contraception methods according to the 2020 CTFG Recommendations related to contraception and pregnancy testing in clinical trials (https://www.hma.eu/fileadmin/dateien/Human_Medicines/01About_HMA/Working_Groups/CTFG/2020_09_HMA_CTFG_Contraception_guidance_Version_1.1_updated.pdf)
- •Known hypersensitivity to the active ingredient or any of the excipients of the study drug
- •Inability to fully understand the potential risks and benefits related to study participation
- •Participation in another interventional clinical study with an investigational product since the last month before enrolment
- •Any other serious medical condition, uncontrolled intercurrent illness or laboratory abnormality that, according to the investigator’s judgement, would constitute an unacceptable risk of premature discontinuation from the study
结局指标
主要结局
Number of participants who are relapse-free for 12 months after Obinutuzumab treatment
Number of participants who are relapse-free for 12 months after Obinutuzumab treatment
次要结局
- Time to protein increase to >3.5g/24H and/or P/C>3500 mg/g along with serum albumin <3.5 g/dl
- Time to B-cell increase to > 5cells/mm3
- Changes in Serum creatinine level, urea, eGFR (by CKD-Epi equation) and mGFR (measured at 6 and 12 months by the iohexol plasma clearance techniques).
- Changes in hematologic parameters (serum total protein, albumin, total, LDL and HDl cholesterol, triglycerides) and in urine parameters (24-hour proteinuria and albuminuria) along with edema and body weight
- Changes in total protein, albumin and IgG fractional clearances
- Changes in participant health-related quality of life as measured by means of the SF-12 questionnaire
研究者
Dr Matias Trillini
Scientific
Istituto Di Ricerche Farmacologiche Mario Negri
研究点 (1)
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