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Steroid-Dependent Nephrotic SyndromePhase 2/3OBIRINSNCT05786768

Efficacy and Safety of Obinutuzumab Versus Rituximab in Childhood Steroid Dependant and Frequent Relapsing Nephrotic Syndrome

A Phase 2/3 study testing single infusion of Rituximab and single infusion of Obinutuzumab in people with Steroid-Dependent Nephrotic Syndrome and Steroid-Sensitive Nephrotic Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

B-cell depletion with rituximab induces sustained remission in children with Steroid-Dependent or Frequent Relapsing Nephrotic Syndrome (SD/FRNS). However, most patients relapse after B-cell recovery and some do not achieve B-cell depletion. Read more about this study

Who is it for?
Ages 3 to 18 years
What is being tested?
single infusion of Rituximab and single infusion of Obinutuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteFrance
Study dates
18 Oct 2023to 30 Jun 2027
Phase
Phase 2/3
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 3 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Age between 3 and 18 years
  • Steroid dependant Nephrotic Syndrome defined as:
  • 2 or more relapses during steroids or within 2 weeks following discontinuation.
  • 2 or more relapses including one under steroid-sparing agent (MMF, Calcineurin inhibitors, cyclophosphamide, levamisole) or within 6 months following treatment withdrawal
  • OR Frequent Relapsing Nephrotic Syndrome defined as:
  • 2 or more relapses within 6 months following first remission
Show all 11Show fewer
  • 3 or more relapses within any 12-month period
  • Last relapse within 3 months prior to inclusion
  • In remission, defined as 3 consecutive urinary dipsticks without proteinuria, at the time of randomization
  • Vaccination schedule in accordance with the current recommendations in France
  • Informed consent from parents

Who cannot join

  • Secondary cause of nephrotic syndrome (such as membranous nephropathy, IgA nephropathy, lupus nephritis)
  • Primary or secondary steroid resistance nephrotic syndrome
  • Prior treatment with Rituximab within 6 months
  • Prior treatment with obinutuzumab at any time
  • CD20+ B-cell count < 2.5%
  • Patient with neutrophils < 1.5 G/L and/or platelets < 75 G/L
Show all 15Show fewer
  • GFR < 80 ml/min/1.73m2
  • Weight <16kg
  • History of severe infection such as tuberculosis, hepatitis B, hepatitis C or HIV infection or LEMP
  • History of malignancy- Uncontrolled infection (viral, bacterial and fungal)
  • Vaccination with a live vaccine within 4 weeks prior to assignment/randomization
  • Known hyperprolinemia
  • Hypersensitivity to the active substance (OBI or RTX) or to proteins of murine origin, or to any of the other excipients
  • Pregnancy or breastfeeding or ability to become pregnant and refusal to use effective contraception during the 18 months following the study treatment (only 1 infusion of obinutuzumab/Rituximab at the beginning of the study)
  • Patient without medical insurance coverage (beneficiary or legal)

Trial locations and contacts

1 site in 1 country.

France1 site

  • Robert Debre Hospital

    Paris, 75019

Other trials in France

About this study

Official title: Efficacy and Safety of Obinutuzumab Versus Rituximab in Childhood Steroid Dependant and Frequent Relapsing Nephrotic Syndrome : a Double-blind Multicenter Randomized Controlled Study

B-cell depletion with rituximab induces sustained remission in children with Steroid-Dependent or Frequent Relapsing Nephrotic Syndrome (SD/FRNS). However, most patients relapse after B-cell recovery and some do not achieve B-cell depletion. Obinutuzumab is a 2nd generation humanized monoclonal antiCD20 antibody, with enhanced B cell-depleting potential. It has been reported safe and efficient in different renal autoimmune diseases including childhood nephrotic syndrome. This double-blind, randomized multicenter study is designed to assess the efficacy and safety of a single infusion of low-dose obinutuzumab compared to a single infusion of rituximab in children with frequently relapsing nephrotic syndrome (FRNS) or steroid-dependent nephrotic syndrome (SDNS).

Read the detailed description

Idiopathic nephrotic syndrome (INS) is the most frequent acquired glomerulopathy in children. The initial treatment relies on steroids, which enables remission of proteinuria in 90% of children. However, 80 % of steroid-sensitive patients will relapse, and 2/3 will become steroid-dependant with a long lasting disease over years. In this situation, immunosuppressive drugs are added as steroid-sparing agents. There is no international consensus on the second line treatment strategy after initial steroid therapy. RCT have demonstrated the efficacy of rituximab (RTX) to maintain remission in FR/SDNS after oral treatments withdrawal, however most patients relapse within 2 years, and some patients are resistant or allergic to Rituximab. Obinutuzumab (OBI) is a second generation antiCD20 mAb, that has been designed to overcome rituximab resistance in B-cell malignancies. Additional mechanisms of rituximab failure support the hypothesis that B-cell depletion could be optimized with OBI in autoimmune diseases. OBI has met its primary endpoint in lupus nephritis and a few randomized controlled trials are currently ongoing in nephrology for lupus nephritis and membranous nephropathy. We believe that a single infusion of OBI could reduce the risk of subsequent relapse in FR/SDNS and the cumulative exposure to immunosuppressive drugs.

Being tested
single infusion of Rituximab, single infusion of Obinutuzumab
Keywords
Rituximab, Obinutuzumab, Anti-Drug Antibodies
Medical subject headings
Nephrotic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • single infusion of RituximabDrug

    Also called single infusion of Rituximab 375 mg/m2

    single infusion of Rituximab 375 mg/m2

  • single infusion of ObinutuzumabDrug

    Also called single infusion of Obinutuzumab 300mg/1.73 m2

    single infusion of Obinutuzumab 300mg/1.73 m2

Study groups in NCT05786768
Study groupRoleWhat they receive
Rituximab 375 mg/m2Active comparatorsingle infusion of Rituximab (375 mg/m2)
Receives: Drug: single infusion of Rituximab
Obinutuzumab 300 mg/1.73 m2Experimentalsingle infusion of Obinutuzumab 300 mg/1.73 m2
Receives: Drug: single infusion of Obinutuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of a relapse within 12 months following the initiation of treatment

    Relapse is defined as a protein to creatinine ratio of 2 g/g of creatinine (0.20 g/mmol) or higher

    Measured: 12 months

Secondary outcomes (8)

  1. Occurrence of a relapse within 24 months

    Measured: 24 months

  2. Time to B-cell depletion

    Measured: 24 months

  3. Duration of relapse-free survival after B-cell reconstitution

    Measured: 24 months

  4. Cumulative steroid courses and second line immunosuppressive treatments in patients with relape

    Measured: 24 months

  5. Safety associated with drug infusion

    Nature, frequency and timing of side effects

    Measured: 24 months

  6. Efficiency defined as incremental cost-effectiveness ratio in cost per relapse prevented

    Measured: 24 months

  7. Budgetary impact defined as costs and health gains incurred with the generalization of the obinutuzumab strategy

    Measured: 24 months

  8. Detection of Antidrug Antibodies

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2023
  2. Study start18 Oct 2023
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05786768
Sponsor's protocol ID
APHP211038
Other IDs
2022-003336-59
Acronym
OBIRINS
Status last verified
Nov 2026
First submitted
10 Feb 2023
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Dossier C, Sellier-Leclerc AL, Simon T, Parmentier C, Boyer O, Samaille C, Fila M, Roussey-Kesler G, Magnavacca M, Chartier Y, Louillet F, Zaloszyc A, Vrillon I, Elaribi D, Bouatia S, Kaguelidou F, Guilmin-Crepon S, Hogan J. Obinutuzumab versus Rituximab to maintain remission in children with steroid-dependent and frequently relapsing nephrotic syndrome: the OBIRINS study protocol, a double-blind randomised controlled trial. BMJ Open. 2025 Dec 24;15(12):e111980. doi: 10.1136/bmjopen-2025-111980.

    PubMed 41448676

  • Larkins NG, Hahn D, Liu ID, Willis NS, Craig JC, Hodson EM. Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children. Cochrane Database Syst Rev. 2024 Nov 8;11(11):CD002290. doi: 10.1002/14651858.CD002290.pub6.

    PubMed 39513526

  • Dossier C, Bonneric S, Baudouin V, Kwon T, Prim B, Cambier A, Couderc A, Moreau C, Deschenes G, Hogan J. Obinutuzumab in Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome in Children. Clin J Am Soc Nephrol. 2023 Dec 1;18(12):1555-1562. doi: 10.2215/CJN.0000000000000288. Epub 2023 Sep 6.

    PubMed 37678236

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing single infusion of Rituximab and single infusion of Obinutuzumab in people with Steroid-Dependent Nephrotic Syndrome and Steroid-Sensitive Nephrotic Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

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 11 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 6 Nov 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 France. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of a relapse within 12 months following the initiation of treatment (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05786768, which also lists 3 linked publications.

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 6 Nov 2026.

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OBIRINS Clinical Trial NCT05786768 | AzTrials