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Nephritis clinical trials

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NCT ID: NCT03828071 Completed - Lupus Nephritis Clinical Trials

Autologous Hematopoietic Stem Cell Transplantation for Refractory Lupus Nephritis

Start date: June 1, 2011
Phase: N/A
Study type: Interventional

In this study, we aimed to evaluate the long term efficacy, remission, survival and safety of autologous hematopoietic stem cell transplantation in patients with refractory lupus nephritis. This is an single arm, non-randomized study. Patients who were diagnosed with relapsed and refractory lupus nephritis would included in this study. Refractory lupus nephritis is defined as no response to at least one type of immunosuppressant therapy (including corticosteroids, cyclophosphamide, tacrolimus, mycophenolate mofetil and cyclosporine) for more than six months, or relapse during the period maintenance therapy with kidney pathological transformation or persistently positive antibodies. Close observation was carried out at stem cell harvest, at transplantation, at 3, 6, 12, 18, and 24 months and then once a year after autologous stem cell transplantation. 20-30 cases will be included in this study.

NCT ID: NCT03791827 Recruiting - Children Clinical Trials

Multicenter Registry of Pediatric Lupus Nephritis in China

Start date: December 1, 2018
Phase:
Study type: Observational

This study is designed to evaluate the efficacy and safety of the current treatment option and outcome of pediatric lupus nephritis patients in China. Investigators will perform prospective registration study among at least 35 pediatric nephrology medical centers in China.

NCT ID: NCT03718585 Recruiting - Clinical trials for Hypertension;Nephropathy

Whole Exome Sequencing in CKD Hypertension

WESCH
Start date: June 1, 2018
Phase:
Study type: Observational [Patient Registry]

The prevalence of hypertension in patients with CKD in China is high but the control rate is low. Compared with the single blood pressure measurement method of the blood pressure of the office, ambulatory blood pressure monitoring (ABPM) can reflect the overall situation of 24-hour blood pressure, dynamic fluctuation degree and circadian rhythm change more completely and objectively. Studies have shown that patients with CKD with hypertension have their own uniqueness through ABPM measurement, and nocturnal hypertension is the main cause of poor blood pressure control. Further studies have shown that nocturnal hypertension is an independent and more effective prognostic indicator of death and CVD in patients with hypertension. Evidence from European and American countries suggests that in the CKD population, elevated nighttime blood pressure is more predictive of CKD progression or CVD than daytime blood pressure. Compared with countries such as Europe and the United States, there are differences in the causes, genetic background and daily behaviors of kidney disease in our population. It is urgent to investigate the predictive value of nocturnal hypertension for renal end point and CVD in CKD population in China. To this end, our study found for the first time that CKD patients generally have changes in nocturnal blood pressure patterns, and the anti-dope type blood pressure pattern is closely related to the target organ damage. Our further study found that the incidence of nocturnal hypertension in Chinese patients with CKD is more than 50%, and compared with non-dipping blood pressure, patients with nocturnal hypertension have more serious target organ damage, which is independent risk factors for all-cause death, cardiovascular death, renal events, and cardiovascular events in patients with CKD. These preliminary results suggest the role of nocturnal hypertension in the prognosis of CKD patients in China, but there are still the following questions: Is the occurrence of nocturnal hypertension in CKD patients related to certain gene expression? This project intends to perform whole-genome exon sequencing and analysis on CKD patients with nocturnal hypertension to determine the genetic mechanism of CKD patients with nocturnal hypertension. The completion of the subject will reveal the genetic characteristics of CKD patients with nocturnal hypertension, and provide a basis for the precise prevention and treatment of chronic kidney disease hypertension.

NCT ID: NCT03687905 Recruiting - Clinical trials for Proliferative Nephritis

Proliferative Lupus Nephritis Treatment With Chloroquine and Hydroxychloroquine

Start date: September 18, 2018
Phase:
Study type: Observational [Patient Registry]

Evaluation the efficacy of chloroquine and hydroxychloroquine in the treatment of proliferative lupus nephritis class III and IV in children and adolescents and evaluate the side effects of both drugs .

NCT ID: NCT03687138 Completed - Lupus Nephritis Clinical Trials

Searching for Diagnostic/Prognostic Biomarkers in SLE With Renal Involvement by Proteomic Techniques

SLE
Start date: June 15, 2018
Phase:
Study type: Observational

Objective: To search for potential biomarkers obtained by non-invasive methods (24-hour urine collection) that distinguish between patients diagnosed with systemic lupus erythematosus with or without renal involvement, patients with non-autoimmune renal disease and healthy donors. Lupus nephritis is one of the most common and severe complications of systemic lupus erythematosus, causing from asymptomatic mild proteinuria to rapidly progressive glomerulonephritis with kidney failure. To date, kidney biopsy (an invasive medical procedure with associated risks and complications) is essential for making a definitive diagnosis, assessing the severity of the damage and deciding on the best treatment. In relation to this, the identification of biomarkers using a non-invasive biological sample could help to classify population groups, and this would be a great step forward in the clinical setting. In this research project, we propose to conduct a case and control study. For this, we will first carefully classify the study groups, using clinical data on patients and by testing a pool of peptides described in the scientific literature in each of the sample groups, using solid phase extraction combined with matrix-assisted laser desorption/ionization time-of-flight mass spectrometry. Subsequently, we will carry out multivariate principal component analysis on the data collected, and calculate corresponding receiver operating characteristic curves, to enable us to identify the masses corresponding to peptides with potential as biomarkers. We will then use classification algorithms to select sets of masses that would allow us to distinguish the population groups, and generate statistical classifiers for assessing the level of confidence in the model and its subsequent validation.

NCT ID: NCT03673748 Recruiting - Lupus Nephritis Clinical Trials

Treatment of Lupus Nephritis With Allogeneic Mesenchymal Stem Cells

MSV_LE
Start date: December 27, 2022
Phase: Phase 2
Study type: Interventional

The 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.

NCT ID: NCT03664908 Completed - Lupus Nephritis Clinical Trials

Detection of Anti-glomerular Basement Membrane Antibodies (Anti-GBM): a Promising Biomarker for Lupus Nephritis (LN)?

GOODLUPUS
Start date: September 1, 2018
Phase: N/A
Study type: Interventional

Introduction 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.

NCT ID: NCT03651492 Recruiting - Sleep Disorder Clinical Trials

Effects of Nocturnal Hypertension on Sleep Quality in Renal Transplant Recipients

Start date: June 1, 2017
Phase:
Study type: Observational

Nocturnal hypertension (i.e. blood pressure values >120/70 or 10% higher than diurnal values, as measured by ambulatory blood pressure monitoring, ABPM) is particularly frequent in renal transplant recipients (RTR), despite the use of antihypertensive drugs. Since RTR are also affected by several sleep disorders (like insomnia, restless legs syndrome, sleep apnoea) that frankly impair their quality of sleep (SQ), the aim of the present study is to ascertain whether a relationship exists between nocturnal hypertension and SQ. In fact, both nocturnal hypertension and sleep disorders may favour the onset or the progression of cardiovascular diseases, the first cause of death in RTR.

NCT ID: NCT03610516 Completed - Lupus Nephritis Clinical Trials

Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Lupus Nephritis.

Start date: September 12, 2018
Phase: Phase 2
Study type: Interventional

This study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary therapeutic efficacy of multiple doses of CFZ533 anti-CD40 monoclonal antibody in patients with moderately active lupus nephritis.

NCT ID: NCT03597464 Completed - Lupus Nephritis Clinical Trials

Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin

AURORA 2
Start date: September 29, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is assess the long-term safety and tolerability of voclosporin compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with lupus nephritis (LN).