Obinutuzumab for Systemic Lupus Erythematosus Pure Membranous Nephropathy: a Phase II Trial (NCT07721363) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Obinutuzumab for Systemic Lupus Erythematosus Pure Membranous Nephropathy: a Phase II Trial
France65 participantsStarted 2026-09-02
Plain-language summary
Lupus nephritis (LN) is a frequent and severe complication of systemic lupus erythematosus, with important mortality and morbidity. International 2024 guidelines recommend immunosuppressive therapy (MMF, cyclophosphamide, calcineurin inhibitors, rituximab, azathioprine) in patients with heavy or uncontrolled proteinuria, but none of these therapies has been evaluated in robust multicenter prospective. Therefore, no treatment has regulatory approval for pure class V LN.
Obinutuzumab, a 2nd-generation B-cell targeting therapy, is more efficient than rituximab in inducing B-cell depletion and complete renal response in patient with class III or IV lupus nephritis.
This study aims to assess the efficacy and safety of an obinutuzumab monotherapy in patients with pure class V LN. The primary endpoint is complete renal response at week 52 according to 2024 KDIGO criteria (UPCR \< 0.5 g/g, eGFR ≥ 85% of baseline, and no intercurrent event: treatment failure, rescue therapy, long-term dialysis, renal transplantation, death or early trial withdrawal)
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Diagnosis of SLE fulfilling the 2019 EULAR/ACR classification criteria (score \> 10)
. Age from 18 to 75 years old included
. Pure class V lupus nephritis, defined on a renal biopsy sample following the ISN/RPS 2003 criteria AND
. For women of childbearing age, agreement to remain abstinent (refrain from heterosexual intercourse) or willingness to use appropriate and effective contraception, as recommended when using obinutuzumab (18 months after last infusion)
. Signature of informed consent
. French social security affiliation (beneficiary or legal)
. Time interval between kidney biopsy showing pure class V LN and baseline visit of no more than 12 months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess, in patients with pure class V lupus nephritis, the efficacy of obinutuzumab to reach complete renal response as defined by 2024 international KDIGO guidelines, 52 weeks after the first obinutuzumab infusion.
Timeframe: week 52 (week 48 to week 56) after the first infusion of obinutuzumab.
. Ongoing treatment (induction or maintenance) for proliferative LN (class III-A or IV-A)
. Negativity for anti-nuclear antibodies (\< 1/80) on immunofluorescence assay
. Severe extra-renal (i.e but not limited to : cardiac, central nervous system, pulmonary, enteric) lupus flare requiring high dose (\> 1 mg/kg/day) corticosteroids.
. Receipt of any of the following excluded therapies:
. Contraindication to the use of obinutuzumab, its premedication drugs or hypersensitivity to its excipients.
. Fewer than 10 non-sclerosed glomeruli analyzable on renal biopsy
. Ongoing pregnancy or breastfeeding women
. CKD stage 4 or 5, defined as eGFR \<30 ml/min/1.73m2 according to CKD-EPI creatinine equation measured two times in an interval of 3 months (to be dissociated from acute kidney injury).