Status:
RECRUITING
Obinutuzumab Induced Decreases of PLA2R Antibodies in Membranous Nephropathy: a Pilot Study
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Membranous Nephropathy - PLA2R Induced
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 immunologic...
Detailed Description
Rationale: Primary membranous nephropathy (PMN) is a leading cause of nephrotic syndrome in adults and is characterized by subepithelial immune complex deposits in the glomerular basement membrane. T...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- Diagnosis of PMN, confirmed by:
- Kidney biopsy or
- Positive serum PLA2Rab test either by IFT and/or ELISA)
- Serum PLA2Rab titer \> 80 RU/ml
- Proteinuria ≥ 3.5 g/24h despite supportive treatment for at least 6 months with a maximally tolerated and stable dose of ACE-i or ARB.
- Serum albumin \< 30 g/l measured by BCP assay.
- eGFR ≥ 30 ml/min/1.73m2.
- Treatment with immunosuppression is warranted, as determined by the treating physician.
Exclusion
- Secondary MN (e.g., hepatitis B or C infection, human immunodeficiency virus infection, active infection, systemic lupus erythematosus, sarcoidosis, IgG4-related, drug-induced, malignancy).
- RTX within 12 months prior to inclusion.
- CNI within 2 months prior to inclusion.
- Treatment with other immunosuppressive drugs within 6 months prior to inclusion.
- Proteinuria must not have decreased by \> 50% over 6 months whilst taking ACEi/ARB.
- Life-threatening nephrotic syndrome resistant to treatment.
- \> 20% increase in serum creatinine not otherwise explained during antiproteinuric supportive treatment.
- Pregnancy or breastfeeding. 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.
- 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.
- Known active infection of any kind or recent major episode of infection.
- 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.
- Inability to understand or comply with the requirements of the study.
- Incapable of recognizing the nature, significance, and scope of the clinical trial or giving consent even with a legal representative.
- Use of an investigational agent.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07163611
Start Date
October 1 2025
End Date
April 1 2028
Last Update
January 6 2026
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Nephrology, Radboud University Medical Center
Nijmegen, Netherlands