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New treatment option for Membranous Nephropathy - PLA2R Induced
Official title Obinutuzumab Induced Decreases of PLA2R Antibodies in Membranous Nephropathy: a Pilot Study
ClinicalTrials.gov ID: NCT07163611
What this study is testing
What is Obinutuzumab administration?
Obinutuzumab administration is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for membranous nephropathy - pla2r induced.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Secondary MN (e.g., hepatitis B or C infection, human immunodeficiency virus infection, active infection, systemic lupus erythematosus, sarcoidosis...
- 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.
See the full eligibility criteria
- 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Nijmegen, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nijmegen, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.