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Study of immunological activity after personalized immunomodulatory therapy regulating the Th17 pathway in patients with extramembranous glomerulonephritis

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503226-39-00
Acronym
22-AOIP-03
Enrollment
5
Registered
2023-06-08
Start date
2023-07-18
Completion date
2025-09-14
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extramembranous glomerulonephritis

Brief summary

Intraindividual variation in anti-PLA2R1 antibody titer (ELISA titer in RU/mL), after 6 months of IFNα (Pegasys®) treatment compared to pre-treatment antibody titer

Detailed description

Intraindividual variation in proteinuria and albumin levels under IFNα (Pegasys®) treatment and stable symptomatic treatment, Intraindividual variation in cytokine profile (assay of 9 cytokines: IL-12p70; IL-17A; IL-4; IL-5; IL-1β; IL-10; IFNα; IL-6 and IFNγ) before and after 6 months of personalized treatment with IFNα (Pegasys®), Clinical and Biological Tolerance of IFNα Therapy (Pegasys®), Description of an effective IFNα (Pegasys®) regimen (one or two monthly doses) to induce an IL-17A level below 73 pg/ml

Interventions

Sponsors

Centre Hospitalier Universitaire De Nice
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Intraindividual variation in anti-PLA2R1 antibody titer (ELISA titer in RU/mL), after 6 months of IFNα (Pegasys®) treatment compared to pre-treatment antibody titer

Secondary

MeasureTime frame
Intraindividual variation in proteinuria and albumin levels under IFNα (Pegasys®) treatment and stable symptomatic treatment, Intraindividual variation in cytokine profile (assay of 9 cytokines: IL-12p70; IL-17A; IL-4; IL-5; IL-1β; IL-10; IFNα; IL-6 and IFNγ) before and after 6 months of personalized treatment with IFNα (Pegasys®), Clinical and Biological Tolerance of IFNα Therapy (Pegasys®), Description of an effective IFNα (Pegasys®) regimen (one or two monthly doses) to induce an IL-17A level below 73 pg/ml

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026