An observational study in Membranous Nephropathy and Major Adverse Kidney Events, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
Among 18 studies in Glomerulonephritis, Membranous with a site in France — 8 open to participants now, 9 under way, 2 of them phase 3. Glomerulonephritis, Membranous · France.
Among the 18 studies in Glomerulonephritis, Membranous with a site in France, this one is one of 4 that started in 2026, is one of 3 observational ones, and was the 18th registered.
146 studies on the registry are indexed under Glomerulonephritis, Membranous; 60 are open to participants now.
Browse Glomerulonephritis, Membranous studies →8 of the 18 studies in Glomerulonephritis, Membranous with a site in France are open now. Recruiting first, the newest first:
AstraZeneca · Sites in France, United States, Belgium and 6 more countries
Ages 18–75
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 18–90
Alexion Pharmaceuticals, Inc. · Sites in France, United States, Argentina and 7 more countries
Ages 18–75
Centre Hospitalier Universitaire de Nice · Sites in France
Ages 18+
Centre Hospitalier Universitaire de Nice · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 41 Glomerulonephritis, Membranous studies recruiting now, 14 (34%) set no upper age limit and 14 (34%) stop at 75 or younger; 8 take children under 18; 2 take healthy volunteers.
This study: 6 Years and older · all sexes · no healthy volunteers.
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18 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 8 · Phase 3 3
First in 2005; this study’s year is marked. 4 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 250 is above the median of 128 across 37 observational studies indexed under Glomerulonephritis, Membranous.
Median enrollment 43 across the 15 interventional studies, 146 across the 3 observational. Of the 8 that completed or were terminated, 2 (25%) have results posted.
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6 of 18 have an industry lead sponsor. The 9 most frequent:
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,596 studies on the registry; 1,037 are open to participants now.
Assistance Publique - Hôpitaux de Paris has 4 studies filed under Glomerulonephritis, Membranous — fewer than ten, so there is no comparison to draw.
2 of the studies in Glomerulonephritis, Membranous with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07157787Alexion Pharmaceuticals, Inc.Study of ALXN1920 in Adult Participants With Primary Membranous Nephropathy (PMN) | 2027-07-02 |
| NCT07930676Assistance Publique - Hôpitaux de ParisEarly PLA2R Status in Severe Anti-PLA2R-mediated Membranous Nephropathy and Long Term Kidney Outcome. | 2027-11 |
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Among the 18 studies in Glomerulonephritis, Membranous with a site in France, from their registry updates:
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This is a multicentric retrospective observational cohort study. The aim of this study is to evaluate, during the initial phase of immunosuppressive treatment for severe PLA2R-positive membranous nephropathy, the independent association between anti-PLA2R antibody trajectories and the occurrence of long-term major kidney events (within 10 years after treatment initiation).
The secondary objectives are :
To assess the association between the initial anti-PLA2R antibody trajectory (between 0 and 6 ± 3 months after treatment, before any potential re-treatment) and the occurrence of nephrological remission.
To assess the association between the initial anti-PLA2R antibody trajectory (between 0 and 6 ± 3 months after treatment, before any potential re-treatment) and the occurrence of immunological remission.
To evaluate, in real-world practice, the safety of immunosuppressive therapies in the treatment of severe PLA2R-positive membranous nephropathy.
Membranous nephropathy (MN) is the leading cause of nephrotic syndrome in non-diabetic Caucasian adults, with a highly variable disease course. One-third of patients achieve spontaneous remission, one-third develop chronic kidney disease, and another third progress to end-stage renal disease (ESRD). This variability necessitates early risk assessment to prevent both overtreatment and disease progression.
Anti-PLA2R antibodies, detected in 60-65% of cases, are crucial for diagnosis and disease monitoring. High antibody levels are associated with a low likelihood of spontaneous remission, often justifying early immunosuppressive therapy. However, the precise predictive value and threshold levels of these antibodies remain unclear.
Among available immunosuppressive treatments, rituximab is favored for its efficacy and low toxicity, making it the standard therapy for MN. However, only 30-35% of patients achieve complete remission within two years, while two-thirds of those without complete remission remain at risk of progression to ESRD.
This variability in response to rituximab is likely influenced by several factors, including excessive urinary drug loss, immune resistance, genetic predispositions, and comorbidities such as obesity and vitamin D deficiency. Although personalized therapeutic approaches are under investigation, large-scale validation is needed.
In conclusion, despite significant advancements, particularly with anti-PLA2R antibodies and rituximab, multicenter studies are required to refine therapeutic strategies and improve long-term outcomes in anti-PLA2R+ MN by promoting a more personalized approach to treatment.
Patients with antiPLA2R positive membranous nephropathy will be obtained from the immunology laboratories of Saint Antoine Hospital and Mondor Hospital (performing all antiPLA2R analysis in Paris).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Occurrence of a major nephrological event within 10 years following immunosuppressive treatment for anti-PLA2R-positive membranous nephropathy
Major adverse kidney event (MAKE) - Composite variable defined by one of the following event: * Initiation of chronic dialysis (duration \> 3 months). * Kidney transplantation. * Chronic kidney disease with a sustained estimated GFR \< 15 ml/min/1.73m², confirmed by two measurements at least 28 days apart. * Sustained decline of \> 50% in GFR from baseline at diagnosis, confirmed by two measurements at least 28 days apart.
Time frame: between diagnostic and last follow-up, up to 10 years
Association between the initial trajectory (defined as the percentage change ((M6 - M0)/M0) in the anti-PLA2R antibody titer
Association between the initial trajectory (defined as the percentage change ((M6 - M0)/M0) in the anti-PLA2R antibody titer, quantified using the ELISA technique, between the titer at the time of initiation of immunosuppressive therapy (D0) and the titer from the first anti-PLA2R measurement performed at 6 ± 3 months after initiation of immunosuppressive therapy (M6 ± 3)) of anti-PLA2R antibodies (from 0 to 6+/-3 months post-treatment) and the occurrence of nephrological response (either complete and/or partial). Nephrological relapse is defined as : * The occurrence of proteinuria \>3 g/g in a patient who had previously achieved complete or partial remission. * The occurrence of a clinically significant relapse, defined as a relapse warranting immunosuppressive therapy in any of specifics situations
Time frame: between diagnostic and last follow-up, , up to 10 years
Association between the initial trajectory of anti-PLA2R antibodies (from 0 to 6 +/- 3 months post-treatment) and the occurrence of immune response
Immunological relapse is defined as reappearance of detectable anti-PLA2R antibodies by ELISA after achieving anti-PLA2R antibody negativity during treatment.
Time frame: between diagnostic and last follow-up, , up to 10 years
Safety of immunosuppressive drugs
Reporting of all adverse event recorded in patients' medical record during follow up. Scoring performed according to the CTCAE v5.0.
Time frame: between diagnostic and last follow-up, , up to 10 years
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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