Investigating immune responses in patients with relapsed membranous nephropathy
In Vitro Study of the Efficacy of Different Immunomodulators on the Th17/Treg Balance in a Cohort of Relapsed Membranous Nephropathy
This study is testing different immune treatments to see if they can help patients with relapsed membranous nephropathy feel better and reduce their chances of future relapses.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Drugs / interventions | Rituximab, tocilizumab, secukinumab |
| Locations | 1 site (Nice) |
| Trial ID | NCT05428605 on ClinicalTrials.gov |
What this trial studies
This study examines the effects of various immunomodulators on the balance between Th17 and Treg cells in patients with relapsed Membranous Nephropathy (MN). By analyzing blood samples, the researchers aim to understand how these treatments can influence cytokine profiles and lymphocyte phenotyping. The goal is to identify optimal therapeutic options for patients experiencing relapses after initial treatment with rituximab. The study focuses on patients with a specific cytokine profile that indicates a high risk of relapse.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with relapsed membranous nephropathy and have not received immunosuppressive treatment for at least six months.
Not a fit: Patients who are pregnant, breastfeeding, or under 18 years of age will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with relapsed membranous nephropathy, potentially reducing the risk of further relapses.
How similar studies have performed: While the approach of investigating Th17/Treg pathways in MN is promising, it is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. Patient with MN proven on renal biopsy or by the presence of anti-PLA2R1 or anti-THDS71 antibodies 3. Relapsed MN, defined as proteinuria \> 3.5g/g after achieving remission (partial or complete, definitions according to KDIGO 2012 guidelines) 4. At a distance from any immunosuppressive treatment (at least 6 months) 5. Freely given informed consent signed by the patient after clear, fair and appropriate information 6. Affiliated to a social security system Exclusion Criteria: 1. Pregnant or breastfeeding woman 2. Patient under 18 years of age 3. Persons of legal age
Where this trial is running
Nice
- Centre Hospitalier Universitaire de Nice — Nice, France (Recruiting)
Study contacts
- Study coordinator: Barbara SEITZ-POLSKI, MD, PhD
- Email: seitz-polski.b@chu-nice.fr
- Phone: +33492035990
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.