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Glomerulonephritis, Membranous clinical trials

View clinical trials related to Glomerulonephritis, Membranous.

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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: NCT06285279 Recruiting - Lupus Nephritis Clinical Trials

FKC288 in Participants With Autoimmune Kidney Diseases

Start date: March 4, 2024
Phase: Phase 1
Study type: Interventional

This study is a single-center, open-label, dose-escalation exploratory clinical trial, expected to enroll 6 to 12 participants. It will use a BOIN (Bayesian Optimal Interval) design for dose escalation, with four predetermined dose groups (0.3×10^6 cells/kg, 1.0×10^6 cells/kg, 3.0×10^6 cells/kg, and an alternative dose of 0.1×10^6 cells/kg). Each dose group plans to enroll 1-2 or 3-6 participants with relapsed or refractory autoimmune-mediated kidney diseases (such as lupus nephritis, ANCA-associated vasculitis, membranous nephropathy, and IgG4-related diseases).

NCT ID: NCT06245707 Recruiting - Clinical trials for Mild Cognitive Impairment

the Effects of Different Treatment Schemes on Cognitive Function of Patients With Idiopathic Membranous Nephropathy

Start date: October 1, 2023
Phase: N/A
Study type: Interventional

This study intends to apply prospective, open, single-center, randomized controlled study to evaluate the cognitive status of patients with Idiopathic membranous nephropathy and the influence of different treatment schemes on the cognitive status of patients with Idiopathic membranous nephropathy, and explore the possible pathophysiological mechanism by using brain magnetic resonance imaging technology.

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: NCT06120673 Not yet recruiting - Clinical trials for Primary Membranous Nephropathy

REmission in Membranous Nephropathy International Trial (REMIT)

REMIT
Start date: July 31, 2024
Phase: Phase 3
Study type: Interventional

REMIT is an investigator-initiated, international, multi-centre, prospective, randomised, open-label, parallel-group trial. A total of 224 adult participants with Primary Membranous Nephropathy (PMN) will be recruited from renal units from Australia, New Zealand Canada, Asia, Europe, United Kingdom, and other countries. Participants will be randomised to receive either corticosteroid and cyclophosphamide or obinutuzumab. The primary outcome is a ranked, composite measure based on (a) efficacy, defined as either complete or partial remission of PMN, (b) number of adverse events, and (c) quality of life.

NCT ID: NCT06065852 Recruiting - Fabry Disease Clinical Trials

National Registry of Rare Kidney Diseases

RaDaR
Start date: November 6, 2009
Phase:
Study type: Observational [Patient Registry]

The goal of this National Registry is to is to collect information from patients with rare kidney diseases, so that it that can be used for research. The purpose of this research is to: - Develop Clinical Guidelines for specific rare kidney diseases. These are written recommendations on how to diagnose and treat a medical condition. - Audit treatments and outcomes. An audit makes checks to see if what should be done is being done and asks if it could be done better. - Further the development of future treatments. Participants will be invited to participate on clinical trials and other studies. The registry has the capacity to feedback relevant information to patients and in conjunction with Patient Knows Best (Home - Patients Know Best), allows patients to provide information themselves, including their own reported quality of life and outcome measures.

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: NCT05914155 Recruiting - Clinical trials for Glomerulonephritis, Membranous

Clinical Study of Rituximab for the Treatment for Idiopathic Membranous Nephropathy With Nephrotic Syndrome

PRIME
Start date: June 24, 2023
Phase: Phase 3
Study type: Interventional

To confirm the efficacy and safety of rituximab (genetical recombination) intravenously administered to idiopathic membranous nephropathy with nephrotic syndrome.

NCT ID: NCT05894512 Recruiting - Clinical trials for Membranous Nephropathy

Analysis of T- and B-Cell Subpopulations in Membranous Nephropathy

Start date: June 1, 2023
Phase:
Study type: Observational

The aim of this observational study is to provide analysis of T and B lymphocyte subgroups in peripheral blood samples of patients with primary membranous nephropathy (MN). A search for disease-related circulating antibodies [anti-phospholipase A2 receptor antibody (anti-PLA2R) and anti-thrombospondin type 1 domain-containing 7A antibody (anti-THSD7A)] in patients' sera is also planned. The main questions to answer are: 1. What is the relationship of these cell populations and their distribution during follow-up with treatment, treatment responses, and relapses? 2. What is the relationship of the cell populations with anti-PLA2R (or anti-THSD7A) antibody levels? Participants will provide peripheral venous blood samples at pre-designated regular intervals. The research team will compare results of the primary MN group with two control groups (IgA nephropathy and healthy volunteer groups) to see if the findings are specific for primary MN.