Actively Recruiting

Age: 18Years +
All Genders
ID06242327

An Observational, Longitudinal Study to Describe the Outcome and Predictors in Patients With Primary Membranous Nephropathy and Nephrotic Syndrome Treated With Rituximab or Other Monoclonal Antibodies

Led by Mario Negri Institute for Pharmacological Research · Updated on 2026-03-23

500

Participants Needed

2

Research Sites

1304 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are tracking the course of primary membranous nephropathy (PMN), a rare autoimmune kidney disease that causes nephrotic syndrome in adults. The study focuses on understanding long-term outcomes for patients in real-world clinical practice, especially in light of new treatment options such as monoclonal antibodies. The goal is to gain insights into disease progression and response to these therapies over time. Participants will be observed without any experimental treatment assigned by the study. The focus is on patients diagnosed with PMN and nephrotic syndrome who have been treated with rituximab or other monoclonal antibodies as part of their care. Researchers will collect data from routine clinical visits and follow patients longitudinally to capture disease remission, progression, and treatment effects. During the study, participants will provide consent for their medical data to be used for research. Researchers will monitor disease remission and progression, kidney function decline, blood parameters, and any adverse events related to treatment throughout the study, which typically spans about six months on average. The study will help understand outcomes and predictors in patients managed with current therapies and support better future care.

CONDITIONS

Brief Title

An Outcome Analysis of Primary Membranous Nephropathy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults (18 years old or older) on the day of signing informed consent
  • Diagnosis of primary membranous nephropathy
  • Nephrotic syndrome with proteinuria greater than 3.5 grams per 24 hours
  • Written informed consent to use recorded data for research purposes
Not Eligible

You will not qualify if you...

  • Legal incapacity or limited legal capacity
  • Any contraindication to treatment with rituximab or other monoclonal antibodies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - Through study completion, an average of 6 months

Participants who have primary membranous nephropathy are observed over time to collect data on disease remission, progression, kidney function, blood parameters, and adverse events.

Regular follow-up visits during the observation period

Trial Site Locations

Total: 2 locations

1

ASST HPG23 - Unità di Nefrologia

Bergamo, BG, Italy, 24127

Active, Not Recruiting

2

Centro di Ricerche Cliniche per le Malattie Rare "Aldo e Cele Daccò"

Ranica, BG, Italy, 24020

Actively Recruiting

Loading map...

Research Team

M

Matias Trillini, MD

P

Piero L Ruggenenti, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

Similar Trials

A Randomized, Controlled Study to Evaluate Safety, Tolerabil...

Membranous Nephropathy

Actively Recruiting

17 locations

PLA2R Autoreactive B-Cell Subsets and Immune Cell Monitoring...

Membranous Nephropathy

Actively Recruiting

1 location

Belimumab and Rituximab Compared to Rituximab Alone for the ...

Membranous Nephropathy

Actively Recruiting

20 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Sexual dimorphic response to rituximab treatment: A longitudinal observational study in a large cohort of patients with primary membranous nephropathy and persistent nephrotic syndrome.

Annalisa Perna, Barbara Ruggiero, Manuel Alfredo Podestà...

https://pubmed.ncbi.nlm.nih.gov/36120314