Obinutuzumab for Primary membranous nephropathy

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years.\n- Diagnosis of primary membranous nephropathy, confirmed by: a) kidney biopsy or b) positive serum anti-PLA2R antibody test (either by IFT and/or ELISA).\n- Serum anti-PLA2R antibody titer > 80 RU/ml.\n- Proteinuria ≥ 3.5 g/24h despite supportive treatment for at least 6 months with maximally tolerated and stable dose of ACE-inhibitor or ARB.\n- Serum albumin < 30 g/l measured by Bromocresol Purple (BCP) assay.\n- eGFR ≥ 30 ml/min/1.73m2.\n- Treatment with immunosuppression is warranted, as determined by the treating physician."}

Exclusion criteria

• {"criterion_text":"- Secondary membranous nephropathy (e.g., hepatitis B or C infection, human immunodeficiency virus infection, active infection, systemic lupus erythematosus, sarcoidosis, IgG4-related, drug-induced, malignancy).\n- Rituximab within 12 months prior to inclusion.\n- Calcineurin inhibitor within 2 months prior to inclusion.\n- Treatment with other immunosuppressive drugs within 6 months prior to inclusion.\n- Proteinuria must not have decreased by > 50% over 6 months whilst taking ACE-inhibitor/ARB.\n- Life-threatening nephrotic syndrome resistant to treatment.\n- > 20% increase in serum creatinine not otherwise explained.\n- Pregnancy or breastfeeding.\n- Women of childbearing age and male patients with female partners of childbearing potential not willing to use contraception throughout the study and for at least 6 months after the last dose of obinutuzumab.\n- Suspected or known hypersensitivity, allergy, and/or immunogenic reaction history to monoclonal antibodies, corticosteroid, cyclophosphamide, any of their ingredients, and any other drugs from these same pharmacotherapeutic groups.\n- Inability to understand or comply with the requirements of the study.\n- Known active infection or recent major episode of infection.\n- Any disorder or condition which might pose an unacceptable risk to patient’s safety and well-being that might interfere with completion of the study.\n- Incapable of recognizing the nature, significance, and scope of the clinical trial or giving consent even with a legal representative.\n- Use of an investigational agent."}

Primary endpoints

• {"endpoint_text":"- Disappearance rate (half-life) of anti-PLA2R antibodies.","definition_or_measurement_approach":"To calculate the disappearance rate (half-life) of anti-PLA2R antibodies. Serum PLA2R antibodies will be measured at baseline, 1, 2, 4, 8, 12, 24, 37 and 52 weeks after obinutuzumab infusions."}

Secondary endpoints

• {"endpoint_text":"- Immunological remission defined as IFT negative.","definition_or_measurement_approach":"Immunological remission defined as negative according to the anti-PLA2R antibody immunofluorescence test (IFT)."}
• {"endpoint_text":"- Efficacy on clinical disease activity, defined as either CR or PR at 12 months.","definition_or_measurement_approach":"Clinical remission classified as complete (CR) or partial (PR) remission at 12 months."}
• {"endpoint_text":"- Adverse events.","definition_or_measurement_approach":"Assessment and categorization of adverse events up to 12 months, categorized as SAE or NSAESI."}
• {"endpoint_text":"- Quality of life during obinutuzumab treatment.","definition_or_measurement_approach":"Quality of life assessed using the Kidney Disease Quality of Life-36 questionnaire; average of scores observed at baseline and in week 12, 24, 37 and 52 or up to study exit."}

Netherlands

Earliest CTIS Part Ii Submission Date

14-07-2025

Latest Decision Or Authorization Date

31-07-2025

Processing Time Days

17

Number Of Sites

1

Number Of Participants

20

Primary sponsor

Full Name

Radboud universitair medisch centrum Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"F. Hoffmann-La Roche Ltd.","duties_or_roles":"will support the study medication (obinutuzumab).","organisation_type":""}