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Nephrosis clinical trials

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NCT ID: NCT03949855 Active, not recruiting - Nephrotic Syndrome Clinical Trials

Belimumab With Rituximab for Primary Membranous Nephropathy

REBOOT
Start date: March 6, 2020
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the effectiveness of belimumab and intravenous rituximab co-administration at inducing a complete remission (CR) compared to rituximab alone in participants with primary membranous nephropathy. Background: Primary membranous nephropathy (MN) is among the most common causes of nephrotic syndrome in adults. MN affects individuals of all ages and races. The peak incidence of MN is in the fifth decade of life. Primary MN is recognized to be an autoimmune disease, a disease where the body's own immune system causes damage to kidneys. This damage can cause the loss of too much protein in the urine. Drugs used to treat MN aim to reduce the attack by one's own immune system on the kidneys by blocking inflammation and reducing the immune system's function. These drugs can have serious side effects and often do not cure the disease. There is a need for new treatments for MN that are better at improving the disease while reducing fewer treatment associated side effects. In this study, researchers will evaluate if treatment with a combination of two different drugs, belimumab and rituximab, is effective at blocking the immune attacks on the kidney compared to rituximab alone. Rituximab works by decreasing a type of immune cell, called B cells. B cells are known to have a role in MN. Once these cells are removed, disease may become less active or even inactive. However, after stopping treatment, the body will make new B cells which may cause disease to become active again. Belimumab works by decreasing the new B cells produced by the body and, may even change the type of new B cells subsequently produced. Belimumab is approved by the US Food and Drug Administration (FDA) to treat systemic lupus erythematosus (also referred to as lupus or SLE). Rituximab is approved by the FDA to treat some types of cancer, rheumatoid arthritis, and vasculitis. Neither rituximab nor belimumab is approved by the FDA to treat MN. Treatment with a combination of belimumab and rituximab has not been studied in individuals with MN, but has been tested in other autoimmune diseases, including lupus nephritis and Sjögren's syndrome.

NCT ID: NCT03899103 Active, not recruiting - Clinical trials for Steroid-Dependent Nephrotic Syndrome

Compare Efficacy and Safety of Repeated Courses of Rituximab to That of Maintenance Mycophenolate Mofetil Following Single Course of Rituximab Among Children With Steroid Dependent Nephrotic Syndrome

RITURNS II
Start date: May 15, 2019
Phase: Phase 3
Study type: Interventional

The aim of the RITURNS II study is to evaluate the efficacy and safety of Repeat courses of Rituximab to that of maintenance Mycophenolate Mofetil following single course of Rituximab in maintaining remission over 24 months among Children with Steroid Dependent Nephrotic Syndrome (SDNS).

NCT ID: NCT03878914 Terminated - Clinical trials for Nephrotic Syndrome in Children

Steroid Sensitive Nephrotic Syndrome in Children

Start date: August 6, 2019
Phase: Phase 4
Study type: Interventional

Idiopathic nephrotic syndrome (INS) is one of the most common glomerular pathologies in children and corticosteroid therapy is its most effective treatment. The total duration of treatment ranges anywhere from two to six months, generally about 3 months. The main objective of our study is to test the feasibility of a shorter total duration (two months) of corticosteroid therapy in patients who show a quicker treatment response to the initial treatment.

NCT ID: NCT03786263 Recruiting - Clinical trials for Nephrotic Syndrome in Children

CHILDNEPH The Canadian Childhood Nephrotic Syndrome Study

CHILDNEPH
Start date: August 3, 2014
Phase:
Study type: Observational [Patient Registry]

CHILDNEPH is a pan-Canadian project to observe clinical care for children with nephrotic syndrome. Previous studies have indicated that there is wide practice variation in how health care providers treat this remitting and relapsing disease of childhood. The disease mechanism is not yet understood, and long-term use of steroids can affect children's health. This study involves assessment of routine clinical care and establishing a long-term patient registry for children with nephrotic syndrome.

NCT ID: NCT03750136 Recruiting - Nephrotic Syndrome Clinical Trials

Furosemide Alone or Unexpectedly With Solution of Hypertonic Saline in Nephrotic Syndrome

FLUSH-NS
Start date: December 15, 2018
Phase: N/A
Study type: Interventional

The trial will test the hypothesis that hypertonic saline on top of standard diuretic treatment will help achieve adequate diuresis in patients with nephrotic syndrome.

NCT ID: NCT03703908 Terminated - Clinical trials for Focal Segmental Glomerulosclerosis

A Study of CCX140-B in Subjects With Primary FSGS and Nephrotic Syndrome

Start date: October 1, 2018
Phase: Phase 2
Study type: Interventional

An Open Label, Intra-Subject Dose Escalation Study of CCX140 B in Subjects with Primary FSGS and Nephrotic Syndrome

NCT ID: NCT03644771 Recruiting - Clinical trials for Decrease of Proteinuria With H.P. Acthar Gel and Its Effects on Clinical and Podocyte Function

Experience With H.P. Acthar Gel Treatment of Patients With Nephrotic Syndrome/Proteinuria Due to Various Etiologies and Its Effect on Podocyte Function

Acthar
Start date: January 25, 2017
Phase:
Study type: Observational

Patients with proteinuria to start treatment with Acthar and watch a variety of clinical parameters with a goal of decreasing proteinuria between 50-100% over a period of nine months with every 3 months increasing the dose of medication until a decrease of either 50- 100 % of protein excretion is achieved. In addition addition podocyte function will be assessed monthly by measuring suPar levels, tnf alpha, podocyte/creatinine levels as well as podocyte function studies.

NCT ID: NCT03592030 Recruiting - Nephrotic Syndrome Clinical Trials

Diagnostic and Prognostic Value of Miss-1 Study in Children and Adult With Nephrotic Syndrome MISSNEPHROTIQUE

MISS-N
Start date: January 2016
Phase:
Study type: Observational

The nephrotic syndrome is a rare disease defined by a proteinuria >3g/24h and a hypoalbuminemia < 30g/L. Genetic and immune are the main causes. The acquired idiopathic nephrotic syndrome presents histologically minimal glomerular lesions, sometimes associated with segmental and focal hyalinosis. The idiopathic nephrotic syndrome (INS) represents 85% of children's glomerular nephropathy and 25-30% of adult's. Relapses are frequents, and can be pejorative up to 10% and lead to end-stage kidney failure. Another immune cause is the extramembranous glomerulonephritis mediated by molecular targets specific autoantibodies expressed at the podocytes surface. Other immune causes include lupus nephropathy, ANCA vascularitis, Goodpasture disease, Berger disease. Easy diagnosis between these causes can be made with the renal biopsy. Miss-1, a new protein activated during a inflammatory event, could be an actor in nephrotic syndromes by modifying the podocyte's adhesion on the glomerular basal membrane. This would modulate the structure and function of the slit diaphragm, as well as junctions between the podocyte and the glomerular basal membrane, regulating podocytes' apoptosis.

NCT ID: NCT03560011 Suspended - Clinical trials for Steroid-Dependent Nephrotic Syndrome

Efficacy and Safety of Immunoglobulin Associated With Rituximab Versus Rituximab Alone in Childhood-Onset Steroid-dependent Nephrotic Syndrome

RITUXIVIG
Start date: April 3, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Idiopathic Nephrotic Syndrome (INS) is the first glomerulopathy in children and 60% of the patients develop Steroid-Dependant Nephrotic Syndrome (SDNS). Recently, rituximab (RTX), a humanized anti-CD20 antibody depleting B cells demonstrated the ability to increase relapse free survival and to decrease the number of relapse and the need of other immunosuppressive drugs. However, the remission rate after 2 years is only 30 to 40%. The aim of the study is to study the ability of intravenous Immunoglobulin to improve remission rate in SDNS when added associated with Rituximab compared to a treatment by Rituximab alone.

NCT ID: NCT03501459 Recruiting - Nephrotic Syndrome Clinical Trials

Lymphocyte Markers As Predictors Of Responsiveness To Rituximab Among Patients With Idiopathic Nephrotic Syndrome

Start date: June 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate if lymphocyte markers predict response to rituximab among patients with idiopathic nephrotic syndrome