Phase Ib Study of SC Milatuzumab in SLE
Lupus ErythematosusCutaneous7 moreMilatuzumab will be given subcutaneously at different dose levels once (depending on the dose level) for 4 weeks to determine if milatuzumab helps to control lupus (SLE).
A Study to Compare the Efficacy and Safety of Tacrolimus Capsules and Cyclophosphamide Injection...
Lupus NephritisThe objective of this study is to evaluate the efficacy and safety of Tacrolimus capsules for induction remission in patients with lupus nephritis, and compare the efficacy and safety with Cyclophosphamide injections.
A Study to Evaluate the Efficacy and Safety of Mizoribine in the Treatment of Lupus Nephritis
Lupus NephritisTo demonstrate that the treatment effect in lupus nephritis of MZR is non-inferior to that of standard therapy CTX through analyzing overall remission rate after treatment.
Rituximab and Belimumab for Lupus Nephritis
Lupus NephritisIn this experimental study, researchers will try to find out if treatment of lupus nephritis with a combination of rituximab and cyclophosphamide (CTX), or a combination of rituximab and CTX followed by treatment with belimumab is safe and if this drug combination can block the immune system attacks.
A Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With International Society...
Lupus NephritisThis was a Phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of rituximab in combination with mycophenolate mofetil (MMF) compared with placebo in combination with MMF in subjects diagnosed with International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV lupus nephritis.
Safety and Efficacy on Deoxyspergualin (NKT-01) in Patients With Lupus Nephritis
Lupus NephritisThe aim of the open multi-center study is to determine an efficient and safe dose and dosing schedule of NKT-01 in induction of response in treatment of lupus nephritis.
The Efficacy and Safety of Calcitriol for the Treatment of Lupus Nephritis and Persistent Proteinuria...
Systemic Lupus ErythematosusNephritis1 moreGlomerulonephritis and renal failure represent one of the most life-threatening manifestations of systemic lupus erythematosus (SLE). Although immunosuppressive therapy is often effective for the treatment of acute lupus nephritis, a significant proportion of patients show persistent proteinuria after resolution of the acute nephritic process, and develop progressive renal failure. There is preliminary evidence that calcitriol and other vitamin D analogs can reduce proteinuria in patients with chronic kidney diseases. The investigators plan to conduct a randomized control study to evaluate the safety and efficacy of calcitriol in the treatment of SLE patients with persistent proteinuria. Sixty patients with clinically quiescent SLE and persistent proteinuria despite conventional therapy will be recruited. They will be treated with calcitriol for 48 weeks. Proteinuria, renal function, lupus disease activity, serum and urinary inflammatory markers will be monitored. This study will explore the potential anti-proteinuric and immunomodulating effects of calcitriol in the treatment of SLE, which is a common and life threatening disease in young adults.
Open Label Pilot Trial of Rituximab in Lupus Membranous Nephritis
Lupus NephritisThe objective of this study is to assess the as efficacy of rituximab as induction therapy in membranous lupus nephritis. Safety and tolerability will additionally be assessed. Subjects will receive open-label 2 courses of rituximab at baseline and at 6 months. They will be followed monthly for 18 months to assess response and durability of response. The hypothesis: B cell depletion will be an effective safe and well tolerated treatment for membranous lupus nephritis (Class V).
Detection of Anti-glomerular Basement Membrane Antibodies (Anti-GBM): a Promising Biomarker for...
Lupus NephritisIntroduction and background : Glomerulonephritis and auto-immune diseases are often associated. Lupus nephritis (LN) is one of the major clinical manifestations of systemic lupus erythematosus (SLE) which have a severe impact on prognosis. This complication is a real challenge for clinicians because of insidious-onset and no predictable relapses. Biomarker use is therefore essential, but conventional biomarkers such as proteinuria have poor sensivity and low specificity to predict LN occurrence, and new more reliable biomarkers (genetic, epigenetic or protein biomarkers) are difficult to use for daily medical practice. Anti-glomerular membrane basement disease (anti-GBM disease) is a rare (0.5 to 1/millions of inhabitants) and severe illness, characterised by rapidly progressive glomerulonephritis, pulmonary haemorrhage and the presence of anti-GBM antibodies, which are highly sensible (100%) and specific (92-100%) of this condition . Our experience and literature review In our department of internal medicine, we report one case of anti-GBM glomerulonephritis associated to an active SLE. After literature review, we note the following studies: some similar association cases had been reported. In 2006, a Chinese cohort study highlighted important rates of anti-GBM antibodies, in serum samples from patients with SLE (14 positives/157patients (8.9%) using ELISA method). Moreover, every SLE patient with positive circulating anti-GMB antibodies LN and a severer SLE (with significantly more anemias, pulmonary hemorrhage). According to histological data's, they also had more important kidney damages (10/14 had necrotizing crescentic glomerulonephritis lesions and 5/14 fulfil criteria's for anti-GBM disease diagnosis). We also note that some authors published experimental studies showing that immunological and genetic links exist between LN and anti-GBM disease, which could explain this association. 3. Main Hypothesis: Based on these findings, we suspect that detection of significant levels of circulating anti-GBM antibodies may be more frequent in SLE followed patients than in general population, and that it could be an interesting biomarker of LN in patient with SLE. 4. Objectives First objective: based on 2 SLE patient groups (one having lupus nephritis and the other without it) we would like to compare the ratio of positive anti-GBM antibodies in each group, expecting a higher rate in SLE patients with LN. Second objective: will be to study the positive anti-GBM group patients in their clinical aspects, serological features and renal characteristics, in this SLE population. 5. Materials and methods We suggest a retrospective analytic transversal controlled study, based on serum samples from the Lupus Biobank of Upper Rhine (LBBR project), and based on serum samples from healthy voluntary blood donors (control group). We will then perform tests in each serum sample group in our immunology laboratory and compare the ratio of positive anti-GBM in each arm.
Velcade for Proliferative Lupus Nephritis
Lupus NephritisProteinuria1 moreThe primary objective is to test the safety and efficacy of Velcade to induce remission in WHO class III/IV/V lupus nephritis that are refractory to standard medications.