Investigating B Cells in Membranous Nephropathy
PLA2R Autoreactive B-Cell Subsets and Immune Cell Monitoring in Membranous Nephropathy: Identification of Outcome Predictors and Novel Insights Into Disease Pathogenesis
This study looks at how certain immune cells called B-cells affect whether patients with membranous nephropathy respond to a specific treatment that targets these cells.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 86 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mario Negri Institute for Pharmacological Research Academic / other |
| Locations | 1 site (Ranica, BG) |
| Trial ID | NCT04095156 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with membranous nephropathy (MN), a leading cause of nephrotic syndrome in adults. It aims to analyze the role of autoreactive B-cells in patients who respond to B-cell depleting therapy with anti-CD20 monoclonal antibodies compared to those who do not. By examining the differences in B- and T-cell compartments, the study seeks to understand why some patients achieve remission while others do not. The research involves in vitro assays to explore these cellular dynamics.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with biopsy-proven idiopathic membranous nephropathy who are either prospective candidates for or have already received B-cell depleting treatment.
Not a fit: Patients with secondary causes of membranous nephropathy or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with membranous nephropathy, enhancing remission rates.
How similar studies have performed: While the approach of analyzing B-cell dynamics in MN is relatively novel, there is limited evidence from previous studies indicating varying responses to B-cell depletion therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients inclusion criteria * Males and females. * Adults (\> 18 years old). * Patients with biopsy-proven idiopathic MN, who are candidate to receive (prospective cohort) or who already received (retrospective cohort) a B-cell depleting treatment as per center clinical practice. * Mental state is such that they are able to understand and give valid consent to the study; * Written informed consent according to the guidelines of the Declaration of Helsinki. Healthy volunteers inclusion criteria * Male and female (\>18 years) not known to suffer of any significant illness; * Not assuming any medication or drug on a regular basis; * Negative urine analysis (urine dipstick, multistick); * Written informed consent according to the guidelines of the Declaration of Helsinki Exclusion Criteria: Patients exclusion criteria * Reasonable possibility of a secondary cause of MN (e.g.systemic lupus erythematosus, active hepatitis B, malignancy, drugs such as gold salts and penicillamine). * Legal incapacity, intellectual disability/mental retardation, dementia, uncooperative attitude or any other evidence that patient will not be able to understand the study procedures and aims and to give written informed consent. Healthy volunteers exclusion criteria \- Legal incapacity, intellectual disability/mental retardation, dementia, uncooperative attitude or any other evidence that patient will not be able to understand the study procedures and aims and to give written informed consent.
Where this trial is running
Ranica, BG
- Centro di Ricerche Cliniche per le Malattie Rare " Aldo e Cele Daccò" — Ranica, Bg, Italy (Recruiting)
Study contacts
- Study coordinator: Manuel Podestà, MD
- Email: manuel.podesta@guest.marionegri.it
- Phone: 003903545351
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.