Long-term outcomes in primary membranous nephropathy
Official title: 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
Run by Mario Negri Institute for Pharmacological Research · NCT06242327 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| 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) |
| Status | Recruiting |
| Started | November 29, 2024 |
| Main results expected | June 2029 |
| Study ends | June 2054 |
| Registry record updated | March 23, 2026 |
| Trial ID | NCT06242327 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Centro di Ricerche Cliniche per le Malattie Rare "Aldo e Cele Daccò"
Ranica, Bg, Italy Recruiting -
ASST HPG23 - Unità di Nefrologia
Bergamo, Bg, Italy Active not recruiting
Study contacts
- Study coordinator: Matias Trillini, MD
- Email: matias.trillini@marionegri.it
- Phone: +3903545351
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study is testing if combining two medications, belimumab and rituximab, can help adults with primary membranous nephropathy feel better and achieve remission more effectively than using rituximab alone.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.