In Vitro Immunomodulation in Membranous Nephropathy Relapses

NCT05428605 | Completed

• 1 other identifier: 20-AOIP-06
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

In order to propose the best therapeutic option to relapsed MN patients with strong activation of the Th17 pathway, the investigators propose to study in vitro the effect of different immunomodulators on the Th17/Treg balance, assessed by cytokine profile and lymphocyte phenotyping using flow cytometry.

Conditions

Extramembranous Glomerulopathy

Keywords

membranous nephropathy; immunomodulation; relapse; Th17/Treg pathways

Outcome Measures

Primary Outcomes (1)

• Cytokine ELISA profiles of the Th17 pathway (IL-17 level), the Treg pathway (IL-10 level), the Th1 pathway (IL-12p70, IFN-γ) and the Th2 pathway (IL-4 and IL-5)

  All cytokines (IL-17, IL-10, IL-12p70, IFN-γ, IL-4 and IL-5) measured by ELISA will be expressed in pg/ml.

  18 months

Secondary Outcomes (1)

• Lymphocyte phenotyping (Treg and Th17) determined by flow cytometry

  18 months

Study Arms (1)

GEM patients

EXPERIMENTAL

Other: Blood sample

Interventions

Blood sample OTHER

10 mL on lithium heparinate tubes, 10 mL on EDTA tubes.

GEM patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Patient with MN proven on renal biopsy or by the presence of anti-PLA2R1 or anti-THDS71 antibodies
• Relapsed MN, defined as proteinuria \> 3.5g/g after achieving remission (partial or complete, definitions according to KDIGO 2012 guidelines)
• At a distance from any immunosuppressive treatment (at least 6 months)
• Freely given informed consent signed by the patient after clear, fair and appropriate information
• Affiliated to a social security system

You may not qualify if:

• Pregnant or breastfeeding woman
• Patient under 18 years of age
• Persons of legal age

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Centre Hospitalier Universitaire de Nice

Nice, 06200, France

Location

Related Publications (1)

• Levraut M, Marignier R, Cohen M, Benoit J, Landes-Chateau C, Maillart E, Cremoni M, Seitz-Polski B, Pinto AL, Dumez P, Honnorat J, Lebrun-Frenay C. Relevance of Kappa and Lambda Free Light Chains in Autoimmune Astrocytopathy Associated With Anti-GFAP Antibodies. Ann Clin Transl Neurol. 2025 Sep;12(9):1785-1793. doi: 10.1002/acn3.70103. Epub 2025 Jun 28.

  PMID: 40581835 RESULT

MeSH Terms

Conditions

Glomerulonephritis, Membranous; Recurrence

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: To compare in vitro the effect of different immunomodulators on Th17/Treg lymphocyte balance in a cohort of relapsed MN patients to determine the best therapeutic approach.

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 23, 2022
• Study Start: May 23, 2022
• Primary Completion: May 30, 2024
• Study Completion: June 6, 2025
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)