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Study of immunological activity after personalized immunomodulatory therapy regulating the Th17 pathway in patients with extramembranous glomerulonephritis
EU CTIS ID: 2023-503226-39-00
What this study is testing
To measure the immunological activity of GEM with anti-PLA2R1 antibodies in immunologically relapsed patients with a Th17-like cytokine profile before and after 6 months of personalized IFNα (Pegasys®) therapy.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subjects 18 years or older
- GEM with anti-PLA2R1 autoantibody
- Immunological relapse (defined by an increase in anti-PLA2R1 antibody titre > 14 RU/mL after a negative phase of anti-PLA2R1 antibodies, that is, immunological remission)
- IL-17A plasma levels > 73 pg/mL after non-specific stimulation of peripheral blood immune cells
- Symptomatic antiprotein treatment with stable and maximum tolerated dosage
- Patients with a biological workup at the screening visit with (i) a platelet count≥ 90,000 cells/mm3; (ii) a neutrophil count ≥ 1500 cells/mm3; and (iii) appropriately monitored normal thyroid function (TSH and T4)
You likely can't join if
- Immunosuppressive treatment for GEM within 6 months prior to the screening visit
- Cancer under treatment
- Pre-existing retinopathies
- Active and severe infections
- Severe liver failure or cirrhosis
- Pregnancy or breastfeeding
See the full eligibility criteria
- Subjects 18 years or older
- GEM with anti-PLA2R1 autoantibody
- Immunological relapse (defined by an increase in anti-PLA2R1 antibody titre > 14 RU/mL after a negative phase of anti-PLA2R1 antibodies, that is, immunological remission)
- IL-17A plasma levels > 73 pg/mL after non-specific stimulation of peripheral blood immune cells
- Symptomatic antiprotein treatment with stable and maximum tolerated dosage
- Patients with a biological workup at the screening visit with (i) a platelet count≥ 90,000 cells/mm3; (ii) a neutrophil count ≥ 1500 cells/mm3; and (iii) appropriately monitored normal thyroid function (TSH and T4)
- Immunosuppressive treatment for GEM within 6 months prior to the screening visit
- Cancer under treatment
- Pre-existing retinopathies
- Active and severe infections
- Severe liver failure or cirrhosis
- Pregnancy or breastfeeding
- Pre-existing severe heart failure
- Pre-existing psychiatric disorder or patient likely to be anxious or depressed (HAD score > 11)
- Patients using substances or abusing substances
- Hypersensitivity to the active substance or excipients of the study treatment
- Secondary GEM (associated with cancer, infectious disease, autoimmune or iatrogenic disease)
- Active nephrotic syndrome defined by KDIGO guidelines as proteinuria > 3.5 g/day (or 3.5 g/g on urine sample) and albumin < 30 g/L
- Absence of immunological (anti-PLA2R1 antibody < 14 RU/mL in ELISA or negative indirect immunofluorescence) and clinical (partial or complete) remission
- Patients with a history of thrombosis or on anticoagulant therapy
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.