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Lupus Nephritis clinical trials

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NCT ID: NCT06113900 Not yet recruiting - Lupus Nephritis Clinical Trials

Assessment of Safety and Efficacy of SGLT2is Among LN Patients

Start date: December 1, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this study is to assess the safety and efficacy of SGLT2is among LN patients.

NCT ID: NCT05964751 Not yet recruiting - Lupus Nephritis Clinical Trials

the Association Between Metabolic Syndrome and Its Components With Lupus Nephritis in Systemic Lupus Erythematosus Patients

Start date: August 1, 2023
Phase:
Study type: Observational

Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease that involve s many different organs and display a variable clinical course. The prevalence of SLE varies across gender, race/ethnicity, and geographic regions. SLE demonstrates a striking female predominance with a peak incidence of disease during the reproductive years. In adults, the female to male ratio is 10-15:1. Clinical features in individual patients can be quite variable and range from mild joint and skin involvement to severe, life-threatening internal organ disease. Constitutional symptoms, rash, mucosal ulcers, inflammatory polyarthritis, photosensitivity, and serositis are the most common clinical features of the disease . Major organ affection in SLE includes Neuropsychiatric involvement (cognitive impairment, depression, psychosis, seizures, stroke, demyelinating syndromes, peripheral neuropathy, etc.) and cardiopulmonary manifestations. Lupus nephritis is the most common of the potentially life-threatening manifestations . Renal involvement is common in SLE and is a significant cause of morbidity and mortality. It is estimated that as many as 90% of patients with SLE will have pathologic evidence of renal involvement on biopsy, but clinically significant nephritis will develop in only 50%. Lupus involvement in the kidney manifests as urinary findings (proteinuria, hematuria, pathologic casts) with or without a rise in serum creatinine. The specific criteria listed for renal involvement are a urine protein > 500 mg/dL or red blood cell casts, Lupus nephritis is often confirmed by kidney biopsy, with the results showing one or more of the classes of lupus nephritis. The metabolic syndrome is a prevalent disorder which is defined by the presence of central obesity, dyslipidemia, hypertension, and disturbed glucose metabolism . It is known that Metabolic syndrome predisposes to cardiovascular disease (CVD) and consequently, to a rise in CVD morbidity and mortality. This syndrome plays a major role in the complex network of systemic pro-inflammatory and prothrombotic states involved in the development of CVD . Compared with patients without Metabolic syndrome, SLE patients from the multinational, multiethnic Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) cohort with the diagnosis of Metabolic syndrome were older, had a higher disease activity, an increased number of recent disease flares, and had accrued more organ damage . Mok et al report that Metabolic syndrome is significantly associated with new organ damage, vascular events, and mortality in patients with SLE .

NCT ID: NCT05962788 Not yet recruiting - Clinical trials for Adolescent Lupus Nephritis

Long-Term Voclosporin Treatment in Adolescent Subjects With Lupus Nephritis

VOCAL-EXT
Start date: March 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the long-term safety and tolerability of voclosporin for up to an additional 12 months following completion of treatment in the AUR-VCS-2020-03 study (VOCAL) in adolescents with active lupus nephritis.

NCT ID: NCT05933213 Not yet recruiting - Lupus Nephritis Clinical Trials

Comparing Mescaline Sodium Enteric-coated Tablets vs Morte-mescaline in the Treatment of Adult Lupus Nephritis

Start date: July 6, 2023
Phase: Phase 4
Study type: Interventional

The goal of this prospective, multicenter,real-world study is to To evaluate the efficacy and safety of mescaline sodium enteric-coated tablets versus morte-mescaline in the treatment of adult patients with lupus nephritis under real-life medical conditions. The main question it aims to answer are: Is the efficacy of mescaline sodium enteric-coated tablets in the treatment of adult patients with lupus nephritis not inferior to morti-mescaline? Participants will receive induction and maintenance treatment with mescaline sodium enteric-coated tablets and morte-mescaline.Then participants will be followed up at 60, 180, 270 and 540 days of treatment to assess the efficacy and safety of mescaline sodium enteric-coated tablets compared to morte-mescaline.

NCT ID: NCT05588830 Not yet recruiting - Lupus Nephritis Clinical Trials

The Efficacy and Safety of Telitacicept and Belimumab in Active Lupus Nephritis in the Real World: a Prospective Cohort Study

Start date: October 20, 2022
Phase:
Study type: Observational

Lupus nephritis is an autoimmune disease. It is an inflammatory kidney damage caused by the deposition of immune complexes in the kidney. It is mainly characterized by the clinical manifestations of albuminuria, hematuria, tubular urine, pyuria, and creatinine elevation. At present, many drugs such as glucocorticoid, immunosuppressant and belimumab are used for clinical treatment, and patients still face difficulties such as complete remission, repeated relapse and so on. This study is a multicenter, prospective, cohort study. In the study, 60 patients with lupus nephritis were enrolled, and they were treated with Telitacicept (n=30) or belimumab (n=30) for 24 weeks on the basis of conventional treatment. To observe the effectiveness and safety of the two treatment schemes for patients. Study drug administration method: Telitacicept was injected subcutaneously, 160mg/time, once a week, for 24 weeks. Belimumab, 10mg/kg, was administered intravenously on the 0, 14 and 28 days, and then once every 28 days until the 24th week During the administration period of this study, the clinician fully evaluated the safety tolerance of patients using this product and decided whether to reduce the dose. The reason for adjusting the treatment plan needs to be recorded. Reference of routine treatment plan: High dose hormone plus cyclophosphamide was used for induction therapy, and then azathioprine or mycophenolate mofetil was used for maintenance therapy; Or high-dose hormone plus mycophenolate mofetil is used for induction therapy, and then mycophenolate mofetil is used for maintenance therapy.

NCT ID: NCT05585671 Not yet recruiting - Clinical trials for Whether Belimumab Could Reduce 2-year Risk of New-onset Lupus Nephritis

Belimumab In Prevention of LN

Start date: June 1, 2023
Phase:
Study type: Observational

Systemic lupus erythematosus is a chronic autoimmune disease, which can involve multiple systems and largely impair patients' health. Kidney is the one of the most commonly affected organs. It was reported that more than about 70% SLE patients developed lupus nephritis, which was highly associated with the long-term prognosis1,2. It will be a great advantage if the high-risk groups could be predicated and prevented with pre-treatment, the renal prognosis and survival would be promisingly improved. The incidence of lupus nephritis within past 10 years in new-onset SLE patients was recorded in our retrospective study, which was highest in their first-year, about 17%, and about 5% per year in the following years3. The raising of risk prediction models and the recognition of high-risk patients are quite important. The prediction model depends on the collection of patient phenotypes, which are scattered in various forms and very cumbersome. In our previous study, a total of 14,439 SLE patients were collected from the rheumatology and immunology departments of 13 Chinese tertiary hospitals in this study, including 13 062 females (90.46%), with an average age of 33.4 years, and the time span of EMR (Electronic Medical Records) was from October 28, 2001 to March 31, 2017. It includes basic information about patients, physical examination, inspection and diagnostic information, etc. We designed a hybrid NLP system combined NLP technical and expert knowledge at the same time, which was named as Deep Phenotyping System (DPS), to extract all the phenotypic information recorded in EMR. The DPS efficiently processed EMR data, and its accuracy, precision, and recall were each greater than 93%. It extracted 73 794 entities from 14,439 SLE cases, each with time attributes, and produced 18,785,000,640 entities. Thus, a LN prediction model was raised, which the likelihood of lupus patients without nephritis will develop lupus nephritis within half and one year can be predicted.) More than 35 000 phenotypes were used in this model and it was verified with independent samples. The best accuracy (ACC) and area under the curve (AUC) predicting the 1-year and 2-year risk of developing lupus nephritis can be achieved 0.88 and 0.86 respectively. The comprehensive SLE phenotype database constructed by NLP greatly improves the research efficiency of lupus clinical phenotype. We first proposed a predictive model of lupus nephritis, which is high applicability and efficiency. The experimental results of good close and open testing fully demonstrate the authenticity and practicality of this database. The research process and method based on real world data are also applicable to predict other important complications of lupus3. Till now, there were no studies investigating secondary prevention tools of lupus nephritis. However, as we all known, disease flare is a high-risk factor of cruel organ damage, and our previous data showed that lupus nephritis was one of the important flare patterns4. Two phase III, randomized, placebo-controlled studies, BLISS-52 and BLISS-76 showed that belimumab, the only FDA-approved biologic in SLE, targeting B Lymphocyte Stimulator, can reduce disease flares compared to standard-of-care (SOC) therapy5,6. A propensity-score matching study further proved that belimumab add on reduces organ damage progression as measured by SDI7. A pooled post-hoc analysis of the BLISS trials took a deeper look at renal outcome, and suggest that belimumab may offer renal benefit in patients with SLE, indicated by less renal flares in belimumab group, that is 1.1% versus 3.0 in the placebo8. We hypothesized and tried to analyze that whether belimumab could act as a secondary prevention tool for SLE patients at high-risk.

NCT ID: NCT05566977 Not yet recruiting - Clinical trials for Type 1 Diabetes Mellitus

Autologous Adoptive T Regulatory Cell Transfer in Autoimmune Diseases.

Start date: December 2022
Phase: Phase 1
Study type: Interventional

Investigators aim to develop an effective and safe treatment of autoimmune diseases through adoptive T regulatory cells transfer. Our objectives are to evaluate the safety and efficacy of autologous adoptive Treg (CD4CD25FoxP3 CD127 low regulatory) cell transfer to patients with refractory autoimmune diseases: Refractory lupus Nephritis, and adults' type1 diabetes mellitus. Patients and Methods: This is Non randomized open label phase 1 pilot study including ten patients with refractory lupus nephritis and ten patients with Type 1 diabetic patients. All patients will be subjected to Full history taking, clinical examination and pretreatment investigations according to the type of autoimmune disease then regulatory T cells (Tregs) identification and count, Treg isolation and expansion and finally administration of T reg cells and follow-up of adverse events and outcomes.

NCT ID: NCT05120882 Not yet recruiting - Lupus Nephritis Clinical Trials

Epidemiology of Lupus Nephritis in Nephrology Unit in Assiut University Hospital

Start date: December 2021
Phase:
Study type: Observational

study epidemiology of lupus nephritis patients admitted to nephrology unit inward or in outpatient clinic in Assiut Nephrology Unit

NCT ID: NCT05111158 Not yet recruiting - Clinical trials for mfERG in Lupus Nephritis

MFERG Study of HCQ Retinopathy in Lupus Nephritis Patients: A Randomized Controlled Clinical Trial

Start date: November 1, 2021
Phase:
Study type: Observational

The aim of the study to assess the multifocal ERG (mfERG) changes in SLE patients treated with chloroquine in renal patients with comparison to SLE patients without kidney affection.

NCT ID: NCT05082363 Not yet recruiting - Lupus Nephritis Clinical Trials

The Expression Profile of New Complement Components in Childhood Lupus Nephritis

Start date: November 2021
Phase:
Study type: Observational

The aim of this study was to evaluate whether C4d is a better biomarker and examine whether C4d plasma levels correlate with treatment response and C4d kidney deposition in systemic lupus erythematosus (SLE) with lupus nephritis (LN).