An Outcome Analysis of Primary Membranous Nephropathy
ConditionMembranous Nephropathy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMario Negri Institute for Pharmacological Research
About this trial
This is an observational study intended to track the course of the primary membranous nephropathy disease in real-world clinical practice.
The study will primarily assess the long-term outcomes of patients with primary membranous nephropathy in the context of advances in treatment options.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Legal incapacity or limited legal capacity.
Any contraindication to treatment with rituximab or other monoclonal antibody
Trial population
The study will enrol all patients with a diagnosis of primary membranous nephropathy and the nephrotic syndrome (proteinuria \>3.5 g/24-h) treated with rituximab or other monoclonal antibodies (including, among others, ofatumumab, obinutuzumab, felzartamab).
Trial design
Design model
Case-only
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Evaluation of disease remission
Combined endpoint of complete (proteinuria \< 0.3 g/24-hours) or partial (proteinuria \<3 g/24-hours with \>50% change vs proteinuria at baseline that is the time of the first rituximab or other monoclonal antibody administration) remission
Time frame
Through study completion, an average of 6 monthsSecondary outcomes
1
Evaluation of disease progression
Assessment of disease progression and identification of the relevant disease outcome
Time frame
Through study completion, an average of 6 months2
Rate of GFR decline
Rate of measured and estimated (CKD-Epi) GFR decline (or improvement)
Time frame
Through study completion, an average of 6 months3
Blood parameter levels
Assessment of blood parameter levels considered as continuous variables
Time frame
Through study completion, an average of 6 months4
Incidence of adverse events
Incidence of adverse events, as assessed and recorded in every-day clinical practice
Time frame
Through study completion, an average of 6 monthsSponsors and contacts
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Source ClinicalTrials.gov