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Glomerulonephritis, Membranous clinical trials

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NCT ID: NCT03804359 Recruiting - Clinical trials for Idiopathic Membranous Nephropathy

Personalized Medicine for Membranous Nephropathy

PMMN
Start date: January 14, 2020
Phase: Phase 2
Study type: Interventional

Randomized, open label, multicentre (20 sites), prospective trial comparing the efficacy of two therapeutic strategies to obtain clinical remission 1 year after diagnosis of Idiopathic Membranous Nephropathy with nephrotic syndrome and anti-PLA2R1 (phospholipase A2 receptor 1) antibodies: - GEMRITUX protocol: 6 months of symptomatic antihypertensive and antiproteinuric therapy, and if the nephrotic syndrome persists at month-6 (urinary protein/creatinine ratio (UPCR) remains > 3.5 g/g and albuminemia < 30 g/l), two 375 mg/m2 rituximab infusions at 1-week interval. - Personalized treatment: - restricted anti-CysR activity at inclusion : 6-month symptomatic antihypertensive and antiproteinuric treatment (KDIGO) - restricted anti-CysR activity after 6 months of symptomatic treatment with persisting nephrotic syndrome (UPCR remains > 3.5 g/g and albuminemia < 30 g/l): two 375 mg/m2 rituximab infusions at 1-week interval; - Anti-CTLD (C-type lectin domains ) 1/7 activity at inclusion or after 6 months with persisting nephrotic syndrome (UPCR remains > 3.5 g/g and albuminemia < 30 g/l): two 1g rituximab infusions at 2-week interval at month 0 and/or month 6.

NCT ID: NCT03549663 Recruiting - Clinical trials for Idiopathic Membranous Nephropathy

Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy (IMN)

Start date: July 4, 2018
Phase: N/A
Study type: Interventional

The trial is a random, open, control and monocentric trial. Mainly to assess the urine protein remission rate of tacrolimus (TAC) monotherapy for idiopathic membranous nephropathy (IMN). Assuming that the urine protein remission rate of 48-week TAC for monotherapy of IMN is not lower than that in treatment group of TAC combined with glucocorticoid, attempt on de-hormonal therapy in the future IMN therapy can be attempted on the basis of the trial results.

NCT ID: NCT03475602 Terminated - Clinical trials for Idiopathic Membranous Nephropathy

Membranous Nephropathy-associated Serological Antibody Predict the Prognosis of Idiopathic Membranous Nephropathy

Start date: March 1, 2018
Phase:
Study type: Observational [Patient Registry]

Idiopathic membranous nephropathy (IMN) remains a common cause of the nephrotic syndrome in adults and one of the leading known causes of end-stage renal disease. Identification of circulating autoantigens provide potential biomarkers for diagnosis and therapy of idiopathic membranous nephropathy. M-type phospholipase A2 receptor (PLA2R) and Thrombospondin type-I domain-containing 7A (THSD7A) were identified as the target antigen in membranous nephropathy with high specificity and the concentration of serum anti-PLA2R antibody and anti-TSHD7A antibody were helpful for predicting disease activity. In our prospective cohort study, hospitalized patients diagnosed as IMN are prospectively studied. Circulating anti-PLA2R antibody and anti-THSD7A antibodies were recently screened by using enzyme-linked sorbent assay(ELISA). This study aims to analyse the difference of clinicopathological characteristics for different concentrations of serum anti PLA2R antibody and anti TSHD7A antibody, and analyze the association between baseline concentrations of serum antibody and disease activity. This study also explored the prediction effects of serum antibody concentrations with different types of therapeutic regimen in IMN and compare the curative effects of different types of therapeutic regimen in different serum antibody concentrations.

NCT ID: NCT03466801 Terminated - Clinical trials for Idiopathic Membranous Nephropathy

The Efficacy of Prednisone and Combination Therapy With Methylprednisolone and Cyclophosphamide on IMN in Stage I.

Start date: March 20, 2018
Phase: N/A
Study type: Interventional

Multi-center, prospective, randomized, controlled study to verify the efficacy of prednisone alone and combination therapy with methylprednisolone and cyclophosphamide in the treatment of stage I membranous nephropathy.

NCT ID: NCT03453619 Active, not recruiting - Lupus Nephritis Clinical Trials

Phase II Study Assessing Safety and Efficacy of APL-2 in Glomerulopathies

Start date: January 22, 2018
Phase: Phase 2
Study type: Interventional

This is a Phase II trial assessing the safety and preliminary efficacy of daily APL-2 subcutaneous infusion administered for 16 weeks with a 6 month safety follow up, in patients with glomerulopathies

NCT ID: NCT03285711 Completed - Clinical trials for Lupus Membranous Nephropathy

Study to Evaluate the Safety and Efficacy of Filgotinib and Lanraplenib in Adults With Lupus Membranous Nephropathy (LMN)

Start date: October 6, 2017
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of filgotinib and lanraplenib (previously GS-9876) in adults with lupus membranous nephropathy (LMN).

NCT ID: NCT03255447 Completed - Clinical trials for Autoimmune Membranous Nephropathy

Peptide GAM Immunoadsorption Therapy in Autoimmune Membranous Nephropathy

PRISM
Start date: November 30, 2016
Phase: N/A
Study type: Interventional

Autoimmune Membranous Nephropathy is now understood to be a condition caused by the immune system although the exact mechanism is not completely known. This study aims to remove the offending part of the immune system using immunoadsorption to not only treat the disease but also use the opportunity to better understand the mechanism of disease. This will allow more targeted treatment in the future with less complications and side effects.

NCT ID: NCT03170323 Recruiting - Clinical trials for Idiopathic Membranous Nephropathy

Mycophenolate Mofetil Plus Steroid in the Treatment Of Patients With Progressive Idiopathic Membranous Nephropathy

MMF-STOP-IMN
Start date: July 1, 2018
Phase: Phase 4
Study type: Interventional

Idiopathic membranous nephropathy (IMN) remains a common cause of the nephrotic syndrome in adults. There are few randomized clinical trials regarding the therapeutic effect of mycophenolate mofetil in patients with Idiopathic membranous nephropathy. This study aims to evaluate whether treatment with mycophenolate mofetil is non-inferior to cyclosporins in inducing long-term remission (complete or partial) of proteinuria in patients with idiopathic membranous nephropathy.

NCT ID: NCT03025828 Completed - Clinical trials for Membranous Nephropathy

Adrenocorticotropic Hormone in Membranous Nephropathy

Start date: March 19, 2018
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the effect of adrenocorticotropic hormone (ACTH, Acthar) on the loss of proteins in the urine (proteinuria) in patients with membranous nephropathy. Acthar is a hormone that stimulates steroid production from small glands above the kidneys. It has direct protective effects on the kidney and is currently approved by the FDA to treat kidney disorders associated with proteins in the urine, but the mechanisms of action are not entirely understood and will be studied in the present trial.

NCT ID: NCT03018535 Active, not recruiting - Clinical trials for Glomerulonephritis, Membranous

Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy

RI-CYCLO
Start date: January 2012
Phase: Phase 3
Study type: Interventional

Idiopathic Membranous nephropathy (IMN) is an auto-immune glomerular disease. Recent studies suggest that circulating auto-antibodies against the podocyte surface antigens phospholipase A2 receptor1 (PLA2R1) and thrombospondin type 1 domain-containing 7A (THSD7A) cause the disease in the majority of the patients. Additional autoantibodies, directed to podocyte neo-expressed cytoplasm proteins have been described, including aldose reductase (AR), Mn-superoxide dismutase (SOD2) and alpha-enolase (alpha-ENO). The commonest presentation of IMN is nephrotic syndrome. Data from placebo arms of interventional studies show that 30-40% of the untreated patients with persistent nephrotic syndrome (NS) progress to end-stage renal disease (ESRD). The best-validated treatment regimen of IMN is combination therapy with steroids and cyclophosphamide, capable to induce remission of protenuria in two-third of the patients. Despite this evidence of efficacy, there are concerns about the use of cyclophosphamide, since it may be associated with adverse events, including bone marrow suppression, gonadal toxicity, infections and oncogenic effects. Thus, the availability of alternative therapies highly effective but with a greater safety profile is desirable. Given the key role of IgG antibodies in IMN, B cell depletion may favourably impact the glomerular disease. The anti-CD20 monoclonal antibody Rituximab is a selective B cell depleting agent. There is evidence that Rituximab is effective in the treatment of other diseases in which B cells play a key role, such as ANCA-related vasculitis. Observational studies in IMN provided encouraging data; in addition, the drug seems well tolerated. Head-to-head comparisons between Rituximab and steroid plus ciclophosphamide in randomized clinical trials are missing. The investigators propose this study in order to test, in a randomized controlled trial, the hypothesis that Rituximab is more effective than cyclical steroid/alkylating-agent therapy in inducing remission in patients with IMN and NS undergoing the initial treatment. In addition, the levels of the above-mentioned pathogenetic autoantibodies will be measured at baseline and during treatment. Finally, the study will compare the safety profile of steroid plus cyclophosphamide and Rituximab by evaluating the rate and severity of adverse events