Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in...
Lupus NephritisThis trial will evaluate efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN
Pre-emptive Treatments in Lupus Nephritis Patients With Serological Reactivation
Lupus NephritisThe optimal management of asymptomatic serological reactivation (ASR) in lupus nephritis (LN) patients remained undefined. This project aims to investigate the impact of pre-emptive treatment on disease relapse in LN patients who experienced ASR.
Daratumumab to Treat Active Lupus Nephritis
Lupus NephritisThe purpose of this research is to study the safety and efficacy of daratumumab in inducing complete or partial remission in patients with active lupus nephritis.
Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)...
Lupus NephritisImmunoglobulin A NephropathyThe objectives of this study are to evaluate the safety and efficacy of ravulizumab administered by intravenous (IV) infusion compared to placebo and demonstrate proof-of-concept of the efficacy of terminal complement inhibition in participants with LN (LN Cohort) or IgAN (IgAN Cohort).
The Study of Comparing the Efficacy and Safety of Human Umbilical Cord MSCs and Low-dose IL-2 in...
Systemic Lupus ErythematosusLupus NephritisThe purpose of this study is to compare the efficacy and safety of human umbilical cord mesenchymal stem cells and low-dose IL-2 in the treatment of LN
Voclosporin in Adolescents With Lupus Nephritis
Adolescent Lupus NephritisThe purpose of this study is to assess the efficacy and safety of voclosporin compared to placebo in achieving renal response following 24 weeks of therapy in adolescents with active lupus nephritis (LN).
Efficacy and Safety of Tacrolimus Versus Mycophenolate in Lupus Nephritis
Lupus NephritisProspective, randomized, parallel-group controlled, open-label, international (Asian) multicenter, comparison of corticosteroids combined with TAC and corticosteroids combined with MMF.
Treatment of Lupus Nephritis With Allogeneic Mesenchymal Stem Cells
Lupus NephritisLupus ErythematosusThe purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSCs) obtained from bone marrow for the treatment of adults with active proliferative lupus nephritis. The objective of this study is to evaluate the efficacy of mesenchymal stem cells (MSCs) in achieving a full or partial response in the treatment of Lupus Nephritis (LN) during its induction period.
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With...
Lupus NephritisThis phase II, randomized, double-blind, placebo-controlled study is designed to evaluate the safety, efficacy and pharmacokinetics of obinutuzumab in adolescent participants aged 12 to less than 18 with biopsy-confirmed proliferative lupus nephritis (LN).
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.