Nephrotic Syndrome，IdiopathicPhase 2OASISNCT07233330
Obinutuzumab in Adult Rituximab-Dependent Nephrotic Syndrome
A Phase 2 study testing Obinutuzumab in people with Nephrotic Syndrome，Idiopathic, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
Trial summary
This is a multicenter, open-label, single-arm Phase II clinical trial designed to evaluate the safety, efficacy, and immunological effects of obinutuzumab in adult patients with multi-relapsing, rituximab-dependent steroid-sensitive NS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrotic Syndrome，Idiopathic
- What is being tested?
- Obinutuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2026to Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Clinical Research Centre for Rare Diseases Aldo e Cele Daccò
Ranica, BG, 24020
Matias Trillini, MD, +39 035 4535 411, matias.trillini@marionegri.it
About this study
Official title: Obinutuzumab Treatment in Frequently Relapsing and Rituximab-Dependent Idiopathic Nephrotic Syndrome in Adults: a Fully Academic, Single-arm, Open, Prospective, Intervention Trial
This is a multicenter, open-label, single-arm Phase II clinical trial designed to evaluate the safety, efficacy, and immunological effects of obinutuzumab in adult patients with multi-relapsing, rituximab-dependent steroid-sensitive NS.
Obinutuzumab is a glycoengineered, humanized type II anti-CD20 monoclonal antibody that was initially developed to overcome rituximab resistance in B-cell malignancies. Obinutuzumab induced a longer and deeper B cell depletion than rituximab being able to deplete B cells in lymphoid tissue other than peripheral blood, as shown in both animal models and patients with chronic lymphocytic leukemia or kidney transplantation. Notably, obinutuzumab was found to be more efficient than rituximab in inducing B-cell cytotoxicity in-vitro, especially on naïve (IgD+CD27-) and switched (IgD-CD27+) memory B cells. This is a clinically relevant finding, because memory B cells are known to be associated with the risk of relapse after rituximab treatment in children with nephrotic syndrome. A recent retrospective study in 41 children [median (IQR) age: 10.6 (8.5-14.29) years] with steroid-dependent or frequently relapsing nephrotic syndrome, showed that treatment with obinutuzumab achieved B-cell depletion and sustained remission in 38 (93%) and 28 (68%) children at 12 and 24 months after treatment, respectively. Treatment was safe and well tolerated. Moreover, preliminary data indicate that obinutuzumab treatment can achieve complete or partial remission of the nephrotic syndrome in the large majority of adult participants with membranous nephropathy refractory to different immunosuppressive medications including rituximab, and even the human type 1 anti-CD20 antibody ofatumumab or the anti-CD38 antibody felzartamab (NCT05050214). Notably, obinutuzumab treatment achieved B-cell depletion and proteinuria reduction in all treated participants and persistent circulating anti-PLA2R antibody depletion in all participants with PLA2R-related disease even during the recovery of circulating B cells (NCT05050214). Conceivably, obinutuzumab could achieve remission of idiopathic nephrotic syndrome by inducing profound and sustained B-cell depletion, thereby inhibiting the production of anti-podocyte autoantibodies or the production of still unknown B-cell derived nephritogenic mediators and autoantibodies.
Read more
Thus, whether obinutuzumab treatment may achieve persistent remission also in adult participants with multi-relapsing, rituximab-dependent nephrotic syndrome, as previously reported in children, and as already observed in adult participants with refractory membranous nephropathy (NCT05050214), and whether this effect is associated with delayed recovery of switched memory B cells and emergence of B cells with a naïve phenotype as well as sustained reduction or depletion of circulating anti-podocyte antibodies is worth investigating.
In parallel to the evaluation of the phenotype of repopulating B cells, we will evaluate serum levels of the B-cell activating factor (BAFF). BAFF is a cytokine that orchestrates peripheral tolerance of B cells and promotes the survival of autoreactive B cells escaping central tolerance mechanisms. In participants with autoimmune diseases, such as systemic lupus erythematosus or rheumatoid arthritis, the relapse of disease activity after rituximab treatment has been associated with compensatory elevation of the B cell-activating factor BAFF levels. Elevated BAFF levels at baseline or during the follow-up may explain the resistance or dependency to anti-CD20 depleting antibodies in participants with idiopathic nephrotic syndrome.
Read the detailed description
About 50% of children with steroid-sensitive nephrotic syndrome become steroid-dependent or frequently relapse. These patients may require prolonged exposure to steroids and immunosuppressive drugs over years to prevent or treat relapses, sometimes beyond adult age. The use of rituximab, a first-generation anti-CD20 monoclonal antibody, has been reported to be safe and effective in most of these cases. We found that rituximab prevented relapses of the nephrotic syndrome in approximately 50% of patients and, overall, as compared to the pre-treatment period, decreased by four-fold the incidence of relapses and reduced the need of steroid therapy to prevent and treat disease recurrences in children as well as adults with multi-relapsing, steroid-dependent idiopathic nephrotic syndrome. Finding that treatment effect was independent of the underlying pathology (minimal change disease, focal and segmental glomerulosclerosis or mesangial glomerulonephritis) suggested that in all cases the disease could be antibody-mediated and response to rituximab could be mediated by depletion of nephritogenic auto-antibodies, as previously observed in patients with PLA2R-related primary membranous nephropathy treated with rituximab. Subsequent studies found that anti-podocyte antibodiesA-B, particularly anti-nephrin antibodies, could play a key pathogenic role in the nephrotic syndrome of minimal change disease as well as of focal and segmental glomerulosclerosis. Conceivably, at least in some cases, anti-CD20 mAb therapy could achieve disease remission by inhibiting the production of these nephritogenic antibodies by autoreactive B cell clones.
Independent of the underlying pathogenetic mechanisms, most patients relapse after B-cell recovery, and some patients do not achieve B-cell depletion or relapse during peripheral B-cell depletion. Moreover, up to 30% of the patients treated with rituximab develop antidrug antibodies against rituximab, which may result in drug intolerance and/or inhibition if the patient receives further courses of rituximab.
- Conditions
- Nephrotic Syndrome，Idiopathic
- Being tested
- Obinutuzumab
- Medical subject headings
- Nephrosis, Lipoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObinutuzumabDrug
Also called Gazyvaro
After induction of remission is achieved, premedication with 1000 mg of paracetamol per os and intravenous infusion of 10 mg of Chlorphenamine and 80 mg of methylprednisolone will be performed on a case to case basis The, 1000 mg of obinutuzumab diluted in 250 mL of normal saline solution will be infused at an initial rate of 50 mg/hour. After every 30 minutes, provided no adverse reaction will occur, the infusion rate will be increased by 50 mg/hour up to a maximum rate of 400 mg/hour. Vital signs will be monitored prior to the infusion, every 15 minutes during the infusion, after infusion completion and then hourly up to infusion end. Participants will be monitored for four hours after completion of drug administration and will be discharged. Then, 1000 mg of obinutuzumab diluted in 250 mL of normal saline solution will be again infused at two and four weeks after the first infusion.
| Study group | Role | What they receive |
|---|---|---|
| Obinutuzumab | Experimental | One vial of 40 mL concentrate contains 1000 mg Obinutuzumab, corresponding to a concentration before dilution of 25 mg/mL. Concentrate for solution for infusion. Receives: Drug: Obinutuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of relapse-free participants
Number of participants who are relapse-free for 12 months after Obinutuzumab treatment
Measured: Follow-up visits, at months 2, 3, 6, 9, 12 after first drug infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study startFeb 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrotic Syndrome，IdiopathicStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Any included participant will serve as his/her own control. No active comparator.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe L Remuzzi, M.D., Study director, Istituto Di Ricerche Farmacologiche Mario Negri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233330
- Sponsor's protocol ID
- OASIS
- Other IDs
- 2025-523306-33-00, 2025
- Acronym
- OASIS
- Status last verified
- Jan 2026
- First submitted
- 14 Nov 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obinutuzumab Treatment in Frequently Relapsing and Rituximab-Dependent Idiopathic Nephrotic Syndrome in Adults: a Fully Academic, Single-arm, Open, Prospective, Intervention Trial
- ClinicalTrials.gov ID
- NCT07233330
- Acronym / sponsor ID
- OASIS / OASIS
- Conditions
- Nephrotic Syndrome，Idiopathic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, open-label, single-arm Phase II clinical trial designed to evaluate the safety, efficacy, and immunological effects of obinutuzumab in adult patients with multi-relapsing, rituximab-dependent steroid-sensitive NS.
Obinutuzumab is a glycoengineered, humanized type II anti-CD20 monoclonal antibody that was initially developed to overcome rituximab resistance in B-cell malignancies. Obinutuzumab induced a longer and deeper B cell depletion than rituximab being able to deplete B cells in lymphoid tissue other than peripheral blood, as shown in both animal models and patients with chronic lymphocytic leukemia or kidney transplantation. Notably, obinutuzumab was found to be more efficient than rituximab in inducing B-cell cytotoxicity in-vitro, especially on naïve (IgD+CD27-) and switched (IgD-CD27+) memory B cells. This is a clinically relevant finding, because memory B cells are known to be associated with the risk of relapse after rituximab treatment in children with nephrotic syndrome. A recent retrospective study in 41 children [median (IQR) age: 10.6 (8.5-14.29) years] with steroid-dependent or frequently relapsing nephrotic syndrome, showed that treatment with obinutuzumab achieved B-cell depletion and sustained remission in 38 (93%) and 28 (68%) children at 12 and 24 months after treatment, respectively. Treatment was safe and well tolerated. Moreover, preliminary data indicate that obinutuzumab treatment can achieve complete or partial remission of the nephrotic syndrome in the large majority of adult participants with membranous nephropathy refractory to different immunosuppressive medications including rituximab, and even the human type 1 anti-CD20 antibody ofatumumab or the anti-CD38 antibody felzartamab (NCT05050214). Notably, obinutuzumab treatment achieved B-cell depletion and proteinuria reduction in all treated participants and persistent circulating anti-PLA2R antibody depletion in all participants with PLA2R-related disease even during the recovery of circulating B cells (NCT05050214). Conceivably, obinutuzumab could achieve remission of idiopathic nephrotic syndrome by inducing profound and sustained B-cell depletion, thereby inhibiting the production of anti-podocyte autoantibodies or the production of still unknown B-cell derived nephritogenic mediators and autoantibodies.
Thus, whether obinutuzumab treatment may achieve persistent remission also in adult participants with multi-relapsing, rituximab-dependent nephrotic syndrome, as previously reported in children, and as already observed in adult participants with refractory membranous nephropathy (NCT05050214), and whether this effect is associated with delayed recovery of switched memory B cells and emergence of B cells with a naïve phenotype as well as sustained reduction or depletion of circulating anti-podocyte antibodies is worth investigating.
In parallel to the evaluation of the phenotype of repopulating B cells, we will evaluate serum levels of the B-cell activating factor (BAFF). BAFF is a cytokine that orchestrates peripheral tolerance of B cells and promotes the survival of autoreactive B cells escaping central tolerance mechanisms. In participants with autoimmune diseases, such as systemic lupus erythematosus or rheumatoid arthritis, the relapse of disease activity after rituximab treatment has been associated with compensatory elevation of the B cell-activating factor BAFF levels. Elevated BAFF levels at baseline or during the follow-up may explain the resistance or dependency to anti-CD20 depleting antibodies in participants with idiopathic nephrotic syndrome.
Detailed description
About 50% of children with steroid-sensitive nephrotic syndrome become steroid-dependent or frequently relapse. These patients may require prolonged exposure to steroids and immunosuppressive drugs over years to prevent or treat relapses, sometimes beyond adult age. The use of rituximab, a first-generation anti-CD20 monoclonal antibody, has been reported to be safe and effective in most of these cases. We found that rituximab prevented relapses of the nephrotic syndrome in approximately 50% of patients and, overall, as compared to the pre-treatment period, decreased by four-fold the incidence of relapses and reduced the need of steroid therapy to prevent and treat disease recurrences in children as well as adults with multi-relapsing, steroid-dependent idiopathic nephrotic syndrome. Finding that treatment effect was independent of the underlying pathology (minimal change disease, focal and segmental glomerulosclerosis or mesangial glomerulonephritis) suggested that in all cases the disease could be antibody-mediated and response to rituximab could be mediated by depletion of nephritogenic auto-antibodies, as previously observed in patients with PLA2R-related primary membranous nephropathy treated with rituximab. Subsequent studies found that anti-podocyte antibodiesA-B, particularly anti-nephrin antibodies, could play a key pathogenic role in the nephrotic syndrome of minimal change disease as well as of focal and segmental glomerulosclerosis. Conceivably, at least in some cases, anti-CD20 mAb therapy could achieve disease remission by inhibiting the production of these nephritogenic antibodies by autoreactive B cell clones.
Independent of the underlying pathogenetic mechanisms, most patients relapse after B-cell recovery, and some patients do not achieve B-cell depletion or relapse during peripheral B-cell depletion. Moreover, up to 30% of the patients treated with rituximab develop antidrug antibodies against rituximab, which may result in drug intolerance and/or inhibition if the patient receives further courses of rituximab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Any included participant will serve as his/her own control. No active comparator.
| Arm | Type | Receives |
|---|---|---|
| Obinutuzumab | Experimental | Drug: ObinutuzumabOne vial of 40 mL concentrate contains 1000 mg Obinutuzumab, corresponding to a concentration before dilution of 25 mg/mL. Concentrate for solution for infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult age (≥18 years old)
- Rituximab-dependent idiopathic nephrotic syndrome is defined and confirmed as:
- 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.
Key exclusion criteria (17 listed)
- Concomitance of clinical conditions that could jeopardize completion of the treatment/observation period and/or confound data interpretation including:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObinutuzumabAlso: GazyvaroAfter induction of remission is achieved, premedication with 1000 mg of paracetamol per os and intravenous infusion of 10 mg of Chlorphenamine and 80 mg of methylprednisolone will be performed on a case to case basis The, 1000 mg of obinutuzumab diluted in 250 mL of normal saline solution will be infused at an initial rate of 50 mg/hour. After every 30 minutes, provided no adverse reaction will occur, the infusion rate will be increased by 50 mg/hour up to a maximum rate of 400 mg/hour. Vital signs will be monitored prior to the infusion, every 15 minutes during the infusion, after infusion completion and then hourly up to infusion end. Participants will be monitored for four hours after completion of drug administration and will be discharged. Then, 1000 mg of obinutuzumab diluted in 250 mL of normal saline solution will be again infused at two and four weeks after the first infusion. | Drug | Obinutuzumab |
Primary outcome
Number of relapse-free participants
Time frame: Follow-up visits, at months 2, 3, 6, 9, 12 after first drug infusion.
Number of participants who are relapse-free for 12 months after Obinutuzumab treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giuseppe L Remuzzi, M.D. study director
Istituto Di Ricerche Farmacologiche Mario Negri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Obinutuzumab in people with Nephrotic Syndrome，Idiopathic, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Piero L Ruggenenti, M.D. (+390352673814, pruggenenti@asst-pg23.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of relapse-free participants (time frame: Follow-up visits, at months 2, 3, 6, 9, 12 after first drug infusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.