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Membranous Nephropathy clinical trials

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NCT ID: NCT06341205 Not yet recruiting - Clinical trials for Membranous Nephropathy

Personalized Rituximab Treatment Based on Artificial Intelligence in Membranous Nephropathy (iRITUX)

iRITUX
Start date: September 1, 2024
Phase: Phase 3
Study type: Interventional

Membranous nephropathy is an autoimmune disease affecting the kidney, and the most common cause of nephrotic syndrome in non-diabetic Caucasian adults. The course of this disease is highly variable from one individual to another, ranging from spontaneous remission to progressive chronic kidney disease. The identification of autoantibodies - e.g., the phospholipase A2 receptor type 1 (PLA2R1) - has promoted the use of immunosuppressive drugs such as rituximab which is now a safe and effective first-line treatment for the management of membranous nephropathy. However, up to 40% of patients do not respond to a first course of rituximab treatment. In nephrotic patients, due to urinary drug loss, rituximab blood level is lower than in other autoimmune diseases treated with rituximab without proteinuria. This high urinary drug loss decreases the drug exposure, potentially explaining why rituximab regimen with low dose infusions (375 mg/m2) did not demonstrate efficacy after month-6 compared to a non-immunosuppressive antiproteinuric treatment in a previous study. In contrast, a regimen of two 1-g infusions two weeks apart was associated with a significantly greater remission rate after 6 months. Recently, the investigators have shown that after two 1-g rituximab infusions, the rituximab blood level 3 months after the first rituximab infusion, was correlated with the likelihood of remission after 6 and 12 months of the rituximab treatment. Patients with positive rituximab blood level 3 months after treatment had a higher chance of remission at month-6 and at month-12 than patients with an undetectable rituximab level at month-3. Nowadays, machine learning algorithms are increasingly used in medicine, especially in pharmacology, to predict the exposure to a drug, the initial dose to administer or the interval between two infusions. The objective of this study is to use a machine learning algorithm predicting the risk of having an undetectable residual level of rituximab 3 months after treatment, in order to propose a personalized treatment management with early additional doses of rituximab for the patients at risk.

NCT ID: NCT06315504 Not yet recruiting - Nephrotic Syndrome Clinical Trials

Circulating Factors in Nephrotic Syndrome

Start date: April 1, 2024
Phase:
Study type: Observational [Patient Registry]

A prospective observational study to investigate the treatment-associated changes of circulating factors associated with glomerular diseases among patients with de novo nephrotic syndrome admitted to hospital for a kidney biopsy.

NCT ID: NCT06242327 Not yet recruiting - Clinical trials for Membranous Nephropathy

An Outcome Analysis of Primary Membranous Nephropathy

PROMENADE
Start date: March 2024
Phase:
Study type: Observational

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.

NCT ID: NCT05941845 Not yet recruiting - Clinical trials for Membranous Nephropathy

Interferon Alfa Therapy Based on Th17 Profile in Membranous Nephropathy

ALPHAGEM
Start date: July 24, 2023
Phase: Phase 2
Study type: Interventional

Membranous Nephropathy (MN) is a renal autoimmune disease mediated by autoantibodies. Current management is based on the use of immunosuppressive therapies. MN patients with a pro-inflammatory Th17 cytokine profile have a 10.5-fold increased risk of disease relapse. Interferon-based immunomodulatory therapies are effective in blocking the production of cytokines in the Th17 pathway avoiding an increased risk of infection, unlike immunosuppressive treatments. To date, these treatments have not been evaluated in the management of MN. The aims of the ALPHAGEM project are to monitor the immunological activity of the disease before and after 6 months of personalized interferon-alfa treatment in MN patients.

NCT ID: NCT04326218 Not yet recruiting - Clinical trials for Membranous Nephropathy

Immunopathological Analysis in a French National Cohort of Membranous Nephropathy

IHMN
Start date: July 1, 2020
Phase: N/A
Study type: Interventional

National cohort of all cases of membranous nephropathy (MN) during a 1 year period in France, based on a pathological and/or serological diagnostic, collecting the data on: - incidence of MN - prevalence of anti-PLA2R1 and anti-THSD7A - clinical outcome one year after diagnosis or after relapse (complete remission, partial remission or persistent nephrotic syndrome) - environmental risk factors for the onset of MN - HLA markers - patient care status in France