Promising antibody therapy may help kidney patients stay Relapse-Free longer
NCT ID NCT07233330
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a drug called obinutuzumab in 10 adults with a kidney condition called nephrotic syndrome that keeps coming back despite standard treatments. The goal is to see if a single course can keep patients relapse-free for at least 12 months by deeply depleting certain immune cells. Participants will be monitored for safety and how long the effect lasts.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 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 (A clinical, rituximab-based B-cell driven treatment protocol that, per Center practice, is aimed to prevent recurrence of the nephrotic syndrome upon re-emergence of CD20+ B cells into the circulation. Rituximab is administered as soon as B-cell counts exceed 5 cells/mm3 in at least two consecutive evaluations) * 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. Exclusion Criteria: * 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 * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Clinical Research Centre for Rare Diseases Aldo e Cele Daccò
Ranica, BG, 24020, Italy
More trials for these conditions
Other studies related to the condition(s) this trial covers.