Induction Therapy for Lupus Nephritis With no Added Oral Steroids: A Trial Comparing Oral Corticosteroids...
Lupus NephritisSystemic Lupus Erythematosus (SLE)This is a randomised, open label, controlled non-inferiority phase III multicentre trial. As primary objective, the study aims to demonstrate that a regimen free of additional oral corticosteroids but with obinutuzumab (and MMF) is non-inferior to a regimen based on oral corticosteroids and MMF in achieving the primary outcome of complete renal response at week 52 without receiving corticosteroids above a prespecified dose. As secondary objectives, the study aims: To compare the efficacy of the treatments in both arms in terms of: partial plus complete renal response at week 52; proteinuria < 0.8g/g at week 52; extrarenal flares; response as defined by a >4 points reduction in SELENA-SLEDAI score at week 52. To compare the safety of the treatments in both arms in terms of occurrence of: toxicity of corticosteroids; serious Adverse Events; serious Infectious Episodes; new damage. To compare the number of patients with non-adherence to treatment in both arms. To estimate the efficiency of obinutuzumab in this indication. The ancillary studies will allow: To implement a biobank (serum, plasma, DNA, cells and urine) and a bank of renal biopsies for studies that will be part of separate research funding bids (patients will be informed that their samples and data may be used for subsequent studies and offered to consent or not). To identify which target therapeutic levels of MMF best predicts response with least toxicity (ancillary study). To have long term data on renal function and damage.
A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients With Lupus Nephritis...
Lupus NephritisTo evaluate the efficacy and safety of efgartigimod IV in Chinese patients with active lupus nephritis (LN)
Study of Daxdilimab (HZN-7734) in Participants With Active Proliferative Lupus Nephritis (LN)
Lupus NephritisPhase 2, multicenter, double-blind, randomized, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of daxdilimab in patients with active, proliferative lupus nephritis (LN).
The Influence of Ketogenic Diet on Lupus Nephritis Patients' Immunity
Systemic Lupus ErythematosusKetogenic DietingThe study investigates the dietary habits in relation to low doses of omega-3 fatty acids in subcutaneous adipose tissue, disease activity and atherosclerosis. The low intake of omega-3 and high intake of carbohydrate among patients with SLE appear to be associated with worse disease activity, adverse serum lipids and plaque presence.Three-month-old mice received an injection of pristane or saline solution and were fed with different experimental diets: sunflower oil diet or extra virgin olive oil (EVOO) diet. After 24 weeks, mice were sacrificed, spleens were collected and kidneys were removed for immunoinflammatory detections. The study have demonstrated that EVOO diet significantly reduced renal damage and decreased cytokine: TNF-α, IL-6, IL-10 and IL-17 production.The ketogenic diet utilizes a high fat, adequate protein, low carbohydrate diet that control type of food and exchange. The aim of the present study that ketogenic diet treated in SLE patients may decrease overactive immunity and associated inflammatory markers.
Early Trial of Allogeneic Hematopoietic Stem Cell Transplantation for Patients Who Will Receive...
SIODCystinosis3 moreThis is a single center, non-randomized, non-controlled open-label phase 1b/2a trial of performing sequential αβdepleted-HSCT and KT in patients requiring KT to prevent kidney rejection post-KT, in the absence of any post-KT immunosuppression, to abrogate the need for lifelong immunosuppression, the risk of chronic rejection and, ultimately, the need for repeated transplantation.
CNCT19 Cell Injection for Refractory Systemic Lupus Erythematosus
Refractory Systemic Lupus ErythematosusLupus Nephritis1 moreInvestigator-initiated, single-arm, open-label, single dose clinical study to evaluate the safety and preliminary efficacy of CNCT19 in treatment of patients with refractory systemic lupus erythematosus(SLE) presented with active lupus nephritis or active immune thrombocytopenia.
Zanubrutinib in Participants With Active Proliferative Lupus Nephritis
Lupus NephritisThe primary objective of this study is to evaluate the efficacy of zanubrutinib added to standard of care as measured by complete renal response for participants with active proliferative lupus nephritis
Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative...
Lupus ErythematosusLupus NephritisThis is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical activity of itolizumab (EQ001) in subjects with Systemic Lupus Erythematosus with or without Active Proliferative Lupus Nephritis
Phase II Study Assessing Safety and Efficacy of APL-2 in Glomerulopathies
IgA NephropathyLupus Nephritis3 moreThis 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
A Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class...
Lupus NephritisThis study will evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab compared with placebo in patients with International Society of Nephrology/Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis (LN) when added on to standard-of-care therapy consisting of mycophenolate mofetil (MMF) and corticosteroids.