Actively Recruiting
Obinutuzumab Induced Decreases of PLA2R Antibodies in Membranous Nephropathy: a Pilot Study
Led by Radboud University Medical Center · Updated on 2026-01-06
20
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
Sponsors
R
Radboud University Medical Center
Lead Sponsor
H
Hoffmann-La Roche
Collaborating Sponsor
AI-Summary
What this Trial Is About
Objective: To assess the disappearance rate (half-life) of anti-PLA2R antibodies in high-risk primary membranous nephropathy (pMN) patients treated with obinutuzumab (OBI), and to evaluate immunological and clinical remission, adverse events, and quality of life. Design: Open-label, single-center, prospective pilot intervention study conducted at Radboud University Medical Center. Population: 20 adult patients with high-risk PMN, defined by proteinuria ≥3.5 g/24h despite 6 months of supportive treatment with ACE inhibitors or ARBs. Intervention: OBI 1000 mg on days 1 and 15, with two additional infusions after 6 months if anti-PLA2R antibody levels remain positive and proteinuria exceeds 2 g/24h. Follow-up: Patients were monitored at baseline, and at weeks 1, 2, 4, 8, 12, 24, 37, and 52.
CONDITIONS
Official Title
Obinutuzumab Induced Decreases of PLA2R Antibodies in Membranous Nephropathy: a Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of primary membranous nephropathy confirmed by kidney biopsy or positive serum PLA2R antibody test (IFT and/or ELISA)
- Serum PLA2R antibody titer greater than 80 RU/ml
- Proteinuria 3.5 g/24h or higher despite at least 6 months of stable and maximally tolerated ACE inhibitor or ARB treatment
- Serum albumin less than 30 g/l measured by BCP assay
- Estimated glomerular filtration rate (eGFR) 30 ml/min/1.73m2 or higher
- Immunosuppressive treatment is warranted as determined by the treating physician
You will not qualify if you...
- Secondary membranous nephropathy from infections, lupus, sarcoidosis, IgG4-related disease, drug-induced causes, or malignancy
- Rituximab treatment within 12 months prior to study
- Calcineurin inhibitor treatment within 2 months prior to study
- Other immunosuppressive drugs within 6 months prior to study
- Proteinuria decreased by more than 50% over 6 months while on ACEi/ARB
- Life-threatening nephrotic syndrome resistant to treatment
- More than 20% unexplained increase in serum creatinine during supportive treatment
- Pregnancy or breastfeeding; unwillingness to use contraception during and 6 months after treatment
- Known allergy or hypersensitivity to monoclonal antibodies, corticosteroids, cyclophosphamide, or related drugs
- Active or recent major infection
- Any condition posing unacceptable risk or interfering with study completion
- Inability to understand or comply with study requirements
- Incapacity to give informed consent
- Use of investigational agents prior to study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Nephrology, Radboud University Medical Center
Nijmegen, Netherlands
Actively Recruiting
Research Team
R
Ruben Visch, M.D.
CONTACT
A
Anne-Els van de logt, M.D., PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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