OBINUTUZUMAB for Idiopathic nephrotic syndrome

Inclusion criteria

• {"criterion_text":"- Adult age (≥18 years old)\n- Rituximab-dependent idiopathic nephrotic syndrome is defined and confirmed as: ●\tAvailability 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 ●\tPrevious history of multi-relapsing, steroid-dependent nephrotic syndrome ●\tPrevious 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 ●\tRelapse 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\n- Estimated GFR by the CKD-Epi creatinine equation (2021) ≥30 ml/min/1.73 m2\n- 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\n- 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"}

Exclusion criteria

• {"criterion_text":"- Concomitance of clinical conditions that could jeopardize completion of the treatment/observation period and/or confound data interpretation including: ●\tActive or recent (< 5 years before enrolment) history of malignancy; ●\tOther active systemic immune diseases requiring concomitant treatment with steroids or any other immunosuppressive agent; ●\tSevere/unstable heart failure requiring hospitalization or changes in pharmacological therapy; ●\tRefractory severe hypertension (BP >180/100 mmHg despite optimized pharmacological treatment with at least three blood pressure-lowering medications); ●\tRecent (within the last 4 weeks) severe infections requiring hospitalization or intravenous antibiotics;Known human immunodeficiency virus infection; ●\tParticipants 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; ●\tPatients with untreated or not fully cured HCV infection; ●\tPlanning a vaccination with live virus vaccines; ●\tActive bacterial, viral and/or fungal infections; ●\tDrug or alcohol abuse.\n- 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\n- Intention to donate ova or sperm over the same time period\n- 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)\n- Known hypersensitivity to the active ingredient or any of the excipients of the study drug\n- Inability to fully understand the potential risks and benefits related to study participation\n- Participation in another interventional clinical study with an investigational product since the last month before enrolment\n- 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"}

Primary endpoints

• {"endpoint_text":"- Number of participants who are relapse-free for 12 months after Obinutuzumab treatment","definition_or_measurement_approach":"Proportion of participants relapse-free for at least 12 months after obinutuzumab; relapse is defined in inclusion criteria as protein increase to >3.5g/24H or P/C>3500 mg/g along with serum albumin <3.5 g/dl. Obinutuzumab administered as soon as remission is achieved by steroid treatment according to center practice."}

Secondary endpoints

• {"endpoint_text":"- Time to protein increase to >3.5g/24H and/or P/C>3500 mg/g along with serum albumin <3.5 g/dl","definition_or_measurement_approach":"Time-to-event measured as time to proteinuria increase meeting >3.5g/24H and/or P/C>3500 mg/g with serum albumin <3.5 g/dl."}
• {"endpoint_text":"- Time to B-cell increase to > 5cells/mm3","definition_or_measurement_approach":"Time-to-event measured as time to peripheral B-cell count increase to >5 cells/mm3."}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Laboratory measurements: serum creatinine, urea, eGFR (CKD-EPI); mGFR measured at 6 and 12 months by iohexol plasma clearance."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Laboratory and clinical assessments of listed hematologic and urine parameters, edema assessment and body weight measurement."}
• {"endpoint_text":"- Changes in total protein, albumin and IgG fractional clearances","definition_or_measurement_approach":"Laboratory measurements of fractional clearances for total protein, albumin and IgG."}
• {"endpoint_text":"- Changes in participant health-related quality of life as measured by means of the SF-12 questionnaire","definition_or_measurement_approach":"Patient-reported HRQoL assessed using the SF-12 questionnaire."}

Italy

Earliest CTIS Part Ii Submission Date

23-01-2026

Latest Decision Or Authorization Date

09-03-2026

Processing Time Days

45

Number Of Sites

1

Number Of Participants

10

Primary sponsor

Full Name

Istituto Di Ricerche Farmacologiche Mario Negri

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Italy

Third parties

• {"country":"","full_name":"ROCHE REGISTRATION GMBH","duties_or_roles":"Providing the investigational drug (Gazyvaro)","organisation_type":""}
• {"country":"Italy","full_name":"GE HEALTHCARE S.R.L.","duties_or_roles":"Supplier/provision of iohexol (OMNIPAQUE) as auxiliary product","organisation_type":""}