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Obinutuzumab Treatment in Frequently Relapsing and Rituximab-Dependent Idiopathic Nephrotic Syndrome in Adults: a fully academic, single-arm, open, prospective, intervention trial
EU CTIS ID: 2025-523306-33-00
What this study is testing
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
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult age (≥18 years old)
- 2. Rituximab-dependent idiopathic nephrotic syndrome is defined and confirmed as: a. Availability of a previous diagnostic kidney biopsy to confirm the diagnosis of MCD, FSGS or IgM glomerulonephritis and quantify the severity of chronic changes; b. Previous history of multi-relapsing, steroid-dependent nephrotic syndrome; c. 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; d. Relapse of the nephrotic syndrome within 12 months after withdrawal of rituximab prophylactic treatment defined as protein increase to >3.5g/24H or 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
You likely can't join if
- Concomitance of clinical conditions that could jeopardize completion of the treatment/observation period and/or confound data interpretation including: a) Active or recent (< 5 years before enrolment) history of malignancy; b) Other active systemic immune diseases requiring concomitant treatment with steroids or any other immunosuppressive agent; c) Severe/unstable heart failure requiring hospitalization or changes in pharmacological therapy; d) Refractory severe hypertension (BP >180/100 mmHg despite optimized pharmacological treatment with at least three blood pressure-lowering medications); e) Recent (within the last 4 weeks) severe infections requiring hospitalization or intravenous antibiotics; f) Known human immunodeficiency virus infection; g) 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 HBsAg-positive or anti-HBcAb positive alone. Subjects with both anti-HBsAb and anti-HBcAb (a condition that may reflect naturally cured infection) are eligible; h) Patients with untreated or not fully cured HCV infection; i) Planning a vaccination with live virus vaccines; j) Active bacterial, viral and/or fungal infections; k) 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
See the full eligibility criteria
Who can join
- Adult age (≥18 years old)
- 2. Rituximab-dependent idiopathic nephrotic syndrome is defined and confirmed as: a. Availability of a previous diagnostic kidney biopsy to confirm the diagnosis of MCD, FSGS or IgM glomerulonephritis and quantify the severity of chronic changes; b. Previous history of multi-relapsing, steroid-dependent nephrotic syndrome; c. 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; d. Relapse of the nephrotic syndrome within 12 months after withdrawal of rituximab prophylactic treatment defined as protein increase to >3.5g/24H or 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
What rules you out
- Concomitance of clinical conditions that could jeopardize completion of the treatment/observation period and/or confound data interpretation including: a) Active or recent (< 5 years before enrolment) history of malignancy; b) Other active systemic immune diseases requiring concomitant treatment with steroids or any other immunosuppressive agent; c) Severe/unstable heart failure requiring hospitalization or changes in pharmacological therapy; d) Refractory severe hypertension (BP >180/100 mmHg despite optimized pharmacological treatment with at least three blood pressure-lowering medications); e) Recent (within the last 4 weeks) severe infections requiring hospitalization or intravenous antibiotics; f) Known human immunodeficiency virus infection; g) 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 HBsAg-positive or anti-HBcAb positive alone. Subjects with both anti-HBsAb and anti-HBcAb (a condition that may reflect naturally cured infection) are eligible; h) Patients with untreated or not fully cured HCV infection; i) Planning a vaccination with live virus vaccines; j) Active bacterial, viral and/or fungal infections; k) 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.