Long-term outcomes in primary membranous nephropathy

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

This project will follow adults with primary membranous nephropathy and nephrotic syndrome to see how their disease and real-world treatments affect long-term kidney outcomes.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Mario Negri Institute for Pharmacological Research (Academic / other)
• Drugs / interventions: rituximab, ofatumumab, obinutuzumab, belimumab, daratumumab, felzartamab
• Locations: 2 sites (Bergamo, BG and 1 other locations)
• Trial ID: NCT06242327 on ClinicalTrials.gov

What this trial studies

This is an observational cohort that will prospectively collect clinical data on adults with primary membranous nephropathy and nephrotic-range proteinuria. Investigators will record treatments chosen in routine care, laboratory measures such as proteinuria and serum albumin, kidney function over time, remission status, progression to end-stage kidney disease, and serious adverse events. No experimental interventions are assigned; the study describes real-world management and outcomes at participating Italian centers. The dataset aims to inform prognostic factors and the real-world effectiveness and safety of current therapeutic approaches.

Who should consider this trial

Good fit: Adults (≥18 years) with a diagnosis of primary membranous nephropathy who have nephrotic-range proteinuria (>3.5 g/24 h) and can give written informed consent are the intended participants.

Not a fit: Patients who do not have primary membranous nephropathy, those without nephrotic-range proteinuria, children, or individuals unable to provide consent or with contraindications to monoclonal antibody therapy are unlikely to benefit from this cohort's insights.

Why it matters

Potential benefit: If successful, the findings could help clinicians identify which patients are at higher risk of kidney failure and refine treatment decisions to reduce progression to end-stage kidney disease.

How similar studies have performed: Previous registries and clinical trials have shown that immunotherapies such as rituximab can induce remission in many patients, but long-term real-world outcome data for contemporary treatment patterns remain limited, making this observational project complementary to prior work.

Eligibility criteria

Inclusion Criteria:

* Adults (≥18 years old) on the day of signing informed consent.
* Diagnosis of primary membranous nephropathy
* Nephrotic syndrome (proteinuria \>3.5 g/24 hours)
* Written informed consent to the use of recorded data for research purposes.

Exclusion Criteria:

* Legal incapacity or limited legal capacity.
* Any contraindication to treatment with rituximab or other monoclonal antibody

Where this trial is running

Bergamo, BG and 1 other locations

• ASST HPG23 - Unità di Nefrologia — Bergamo, Bg, Italy (Active_not_recruiting)
• Centro di Ricerche Cliniche per le Malattie Rare "Aldo e Cele Daccò" — Ranica, Bg, Italy (Recruiting)

Study contacts

• Study coordinator: Matias Trillini, MD

Conditions Membranous Nephropathy; Primary Membranous Nephropathy; Nephrotic Syndrome