Early PLA2R Status in Severe Anti-PLA2R-mediated Membranous Nephropathy and Long Term Kidney Outcome.
NCT07930676, Not yet recruiting, Assistance Publique - Hôpitaux de Paris
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Early PLA2R Status in Severe Anti-PLA2R-mediated Membranous Nephropathy and Long Term Kidney Outcome. | ClinicalTrials.gov |
| NCT number | NCT07930676 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 250 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Assistance Publique - Hôpitaux de Paris | ClinicalTrials.gov |
| Conditions | Membranous Nephropathy, Major Adverse Kidney Events | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Occurrence of a major nephrological event within 10 years following immunosuppressive treatment for anti-PLA2R-positive membranous nephropathy | between diagnostic and last follow-up, up to 10 years | 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. | ClinicalTrials.gov |
| Secondary | Association between the initial trajectory (defined as the percentage change ((M6 - M0)/M0) in the anti-PLA2R antibody titer | 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, 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 | ClinicalTrials.gov |
| Secondary | Association between the initial trajectory of anti-PLA2R antibodies (from 0 to 6 +/- 3 months post-treatment) and the occurrence of immune response | between diagnostic and last follow-up, , up to 10 years | Immunological relapse is defined as reappearance of detectable anti-PLA2R antibodies by ELISA after achieving anti-PLA2R antibody negativity during treatment. | ClinicalTrials.gov |
| Secondary | Safety of immunosuppressive drugs | between diagnostic and last follow-up, , up to 10 years | Reporting of all adverse event recorded in patients' medical record during follow up. Scoring performed according to the CTCAE v5.0. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.3.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
Release trials-2026-11-12-0.3.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.