The Effect of Curcumin on the Clinical Outcome of Pediatric Patients With Active Lupus Nephritis...
Lupus NephritisSLE NephritisPediatric Lupus nephritis which is a sever and common complication to childhood onset systemic lupus erythematous is an aggressive inflammatory process triggered by the deposition of antigen-antibody complex in kidney tissue. The complex stimulates production of multiple immune cells, activating Inflammasome NLRP3 that plays massive role in stimulating various cytokines like IL-6. The inflammation also causes elevation in proteinuria and serum creatinine levels beside other inflammatory markers elevation (CRP )and (ESR). These children are treated with a standard regimen consists of an immunomodulator (mycophenolate mofetil) with strong steroid anti-inflammatory and also hydroxychloroquine is added to the regimen to decrease the intensity of the flares and management of arthritis symptoms. In our study we are introducing a powerful antioxidant and anti-inflammatory drug with nephroprotective benefits which is curcumin capsules. The drug showed success in managing different autoimmune and inflammatory diseases as rheumatoid arthritis and Crohn's disease, it also showed dramatic improvement in lupus nephritis models in previous experimental study. The study primary outcome is will be the composite of the effect of curcumin on Urine protein-to-creatinine ratio and NLPR3 Inflammasome levels in blood. Patients meeting the study inclusion criteria will be educated firmly about the disease details and all information about the drug, then will be randomly assigned to one of two groups, the first group receiving the standard therapy only while the second one receiving the standard therapy beside the curcumin 1000 mg capsules orally daily, a third small group of healthy children as a control for normal inflammasome levels. Patients in the first two groups will undergo baseline evaluation at the beginning of the study including Patients' demographic data, anthropometric measures and medication history. Moreover, collecting patients' medical history which includes Duration of systemic lupus, Duration of lupus nephritis, other organs involvement, past and current medical condition or prescribed and OTC medications. Laboratory Evaluation and renal function assessment will include Inflammasome levels in blood using ELISA technique using Human NLRP3 ELISA Kit, Serum creatinine levels, Protein in urine levels, estimated glomerular filtration rate (eGFR) using Original Schwartz Equations, Inflammatory biomarkers (ESR, CRP), anti-ds DNA, anti-ANA DNA and evaluating Hematuria. Baseline Clinical evaluation includes Blood pressure measurement and Kidney structural damage evaluation via biopsy. Then patients will be followed up monthly for three months for assessing Patient Compliance with the prescribed medication regimens and the study drug, Occurrence of side effect graded using monitoring of side effects scale (MOSES) and checking for Allergic reactions against the drug. After the three months, all patients will be reassessed for all laboratory and clinical evaluations. finally results will be statistically analyzed Statistical analysis will be done using SPSS statistical software package
An Open-label, Study to Assess Safety, Efficacy and Cellular Kinetics of YTB323 in Severe, Refractory...
Systemic Lupus ErythematosusLupus NephritisThe study is intended to assess safety, efficacy and cellular kinetics of YTB323 treatment in participants with severe refractory systemic lupus erythematosus.
RY_SW01 Cell Injection Therapy in Active Lupus Nephritis
Lupus NephritisRY_SW01 Cell Injection's preclinical research results have shown that the injection significantly improved urine biochemical indicators and tissue damage in two lupus nephritis animal models after MSC administration, with no occurrence of rejection and excellent safety. The mechanism of action of RY_SW01 Cell Injection is relatively clear, demonstrating favorable therapeutic effects in preclinical animal models. Compared to existing conventional therapies, it has the advantages of "convenient treatment and sustained efficacy." It may help reduce the variety and quantity of drugs administered to patients and the various side effects associated with drug treatment. In some cases, it may even lead to the discontinuation of immunosuppressive drugs, reducing mortality and disability rates while improving the quality of life for patients. Its unique advantages have the potential to fundamentally change the current clinical treatment landscape and offer promising prospects for clinical application.
Minimizing Glucocorticoid Administration in Patients With Proliferative Lupus Nephritis
Lupus NephritisThe aim of the study is to evaluate the efficacy of a therapeutic regimen which decreases glucocorticoid exposure compared with standard therapy in patients with proliferative lupus nephritis during remission induction by evaluating the histological and clinical remission.
A Study of ANX009 in Adult Participants With Lupus Nephritis
Lupus NephritisThe main purpose of this study is to determine the safety and tolerability of repeat doses of ANX009 in participants with lupus nephritis (LN).
MMF Versus CYC in the Induction Therapy of Pediatric Active Proliferative LN
Mycophenolate MofetilCyclophosphamide1 moreA prospective, randomized, multicenter, open-label, parallel-arm Study to compare effectiveness of mycophenolate mofetil versus cyclophosphamide in the Induction Therapy of pediatric patients with Active Proliferative Lupus Nephritis in Chinese population
Mesenchymal Stromal Cells (MSC´s) in Renal Lupus
Lupus ErythematosusSystemic1 morePhase II Clinical Trial to Assess the dose-response and Efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells (MSCs) in Severe Renal Systemic Lupus Erythematosus (SLE).
Per-protocol Repeat Kidney Biopsy in Incident Cases of Lupus Nephritis
Lupus NephritisLupus nephritis (LN) is one of the most severe complications of systemic lupus erythematosus (SLE). Among people living with SLE, 35-60% will develop LN during the course of the disease. This complication is one of the factors that contribute to deterioration of the renal function. Some centres perform kidney biopsies after completion of treatment for an episode of LN as a part of the treatment evaluation. The term "repeat biopsy" is often used to describe these biopsies. Several studies have reported that repeat kidney biopsies show activity at the level of tissue, even in patients with normal routine blood and urine markers. The investigators strongly believe that this information is important, and should be taken into consideration during decision of treatment. To provide evidence for this, the investigators have designed a collaborative project within the frame of the Lupus Nephritis Trials Network. With this research project, the investigators want to contribute to an increased proportion of patients with LN who achieve remission (inactivity) of LN, and a reduced proportion of patients who worsen in renal function in the long term. Patients with SLE who develop a first episode of LN will be asked to participate in this project, and will receive treatment according to current guidelines. Half of the patients will undergo a repeat biopsy 12 months later, and half of the patients will not. The selection of patients who will undergo or not undergo repeat biopsy will be random. Patients with high disease activity at the level of kidney tissue will receive more intense immunosuppressive treatment. Patients who have not undergone repeat biopsy will continue to be treated according to standard routine. The investigators will compare the results of treatment between the group of patients who underwent and the group of patients who did not undergo repeat biopsy, with regard to (i) complete disease inactivity at month 24 and (ii) renal function at month 60 from treatment initiation. The investigators expect that significantly greater proportions of patients in the repeat biopsy group will have inactive disease at month 24 and adequate levels of renal function at month 60. This will provide support for performing repeat biopsies as a part of the treatment evaluation, in order to optimise the therapeutic management and improve the long-term prognosis of patients with LN.
Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis
Lupus NephritisThe purpose of this study is to evaluate the efficacy and safety of IV antifrolumab in adult patients with Active Proliferative Lupus Nephritis
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