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Nephritis clinical trials

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NCT ID: NCT03200002 Completed - Clinical trials for To Compare the Effects of Mycophenolate Mofetil With Cyclophosphamide in Neplaese Lupus Nephritis Patients

Cyclophosphamide Versus Mycophenolate Mofetil in Lupus Nephritis

Start date: January 1, 2014
Phase: Phase 2
Study type: Interventional

This was a prospective open label randomized control trial, which was conducted for a period of one and half year from January 2014 to June 2015. Out of 52 patients screened, 49 patients meeting the international society of nephrology/ renal pathology society (ISN/RPS) criteria were enrolled in the study comprising of 25 and 24 patients in the cyclophosphamide (CYC) and mycophenolate mofetil (MMF) groups respectively. Forty two patients (21 in each group) could complete the study till the end of 6 months and were included in final analysis. Baseline clinical evaluation and investigations were done and recorded. CYC was given intravenously as a monthly pulse in the dose of 0.5 to 1 gram per m2 body surface area. MMF was administered in the tablet form with the starting dose of 500 mg twice daily, which was increased to 750 mg twice daily after a month. Patients were assessed and monitored monthly and the details were recorded. Efficacy of treatment was measured as primary end point for those who achieved partial remission (reduction of 24 hour urinary protein to < 3.5gms/day if baseline proteinuria >3.5 gms/day or decrease by 50% if baseline proteinuria <3.5 gms/day) and secondary end point for those who achieved complete remission (normalization of serum creatinine and < 500 mg of 24 hour urinary protein). Adverse events experienced by the patients were also recorded during monthly visit.

NCT ID: NCT03180021 Completed - Lupus Nephritis Clinical Trials

Dynamic Imaging of Variation in Lupus Nephritis

DIVINE
Start date: March 13, 2018
Phase:
Study type: Observational

To use a variety of renal imaging modalities, including diffusion weighted imaging (DWI), blood oxygen level dependent (BOLD) imaging, T1rho (T1rho) imaging, and dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) to evaluate the intra-renal blood flow, perfusion, cellularity, fibrosis and atrophy within the kidneys of patients with lupus nephritis (LN) and compare these parameters to renal biopsy findings to determine whether DWI, BOLD, T1rho, and DCE-MRI may provide a set of non-invasive tools to assess renal function and pathology in LN.

NCT ID: NCT03174587 Completed - Lupus Nephritis Clinical Trials

Evaluate the Safety of CS20AT04 Inj. in Subjects With Lupus Nephritis

Start date: May 30, 2017
Phase: Phase 1
Study type: Interventional

The purpose of conducting phase 1 trial to evaluate the safety and tolerability of allogenic bone marrow-derived mesenchymal stem cells(CS20AT04) in subjects with lupus nephritis. Evaluating DLT by IV injection according to dose-escalating in lupus nephritis patients.

NCT ID: NCT03063281 Completed - Clinical trials for Lupus Erythematosus, Systemic

Anti-ficolin-2 Autoantibodies in Lupus Nephritis

Ficolupus2
Start date: November 2012
Phase: N/A
Study type: Observational

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by the production of multiple autoantibodies. The prevalence and significance of antibodies against Ficolin-2 have not been yet investigated. The aims of this study were to determine the prevalence of anti-ficolin-2 antibodies among SLE patients and to investigate their potential as diagnostic and/or prognostic biomarkers in SLE. This study is a secondary phase of a serum sample analysis done in early 2015 in order to determine the prevalence of anti-ficolin-2 antibodies among the same cohort as the previously declared study (ClinicalTrials.gov ID: NCT02625831; Unique Protocol ID: 1841851v0). In this retrospective study, clinical data were obtained from medical files and blood samples were selected from preexisting biological collection. SLE patients (n=165) were informed and did not objected, they were matched to healthy controls (n=48). Disease activity was determined according to the SLEDAI score. Anti-ficolin-2 antibodies levels were measured in sera by ELISA and correlated to previously obtained Anti-ficolin-3, Anti-ficolin-2, anti-dsDNA and anti-C1q antibodies levels. The titer of anti-ficolin-2 antibodies was correlated with the SLEDAI score (p<0.0001). The presence of anti-ficolin-2 antibodies was associated with anti-ficolin-3 antibodies, anti-C1q and anti-dsDNA antibodies. Interestingly, the combination of anti-ficolin-3, anti-ficolin-2 and anti-C1q antibodies demonstrated higher specificity than any other traditional biomarker. These results suggest that anti-ficolin-3 and anti-ficolin-2 antibodies could be useful for the diagnosis of active nephritis in SLE patients.

NCT ID: NCT03031925 Completed - Lupus Nephritis Clinical Trials

Detection of Annexin A2 in Systemic Lupus Erythematosus

ANLUP
Start date: May 9, 2017
Phase: N/A
Study type: Interventional

There is substantial clinical and biological intra and inter-patient variability in SLE. Vascular, renal and neurologic deficiency can be organ-threatening or even life-threatening, leading to increased morbidity and mortality. Thus, biomarkers of disease activity and prognosis are required for regular follow-up of SLE patients. Implication of Toll-like Receptors (TLRs) in SLE has been extensively studied in mice models and humans. Self nuclear antigens bind to TLRs which are located on the surface of dendritic cells, B-cells, and endothelial cells, leading to production of pro-inflammatory cytokines and pathologic autoantibodies involved in organ dysfunction of SLE patients. Moreover, TLR expression in SLE is significantly higher and significantly correlated with disease activity. Annexin A2 (ANXA2) is a member of the annexins superfamily which exists as a monomer or heterotetramer and is implicated in several biological processes. Most notably, it binds to ẞ2GP1/anti-ẞ2GP1 antibodies and mediates endothelial cell activation via a TLR4 signaling pathway, highlighting its key role in Antiphospholipid Syndrome (APS) frequently associated with SLE. ANXA2 is also involved in the physiopathology of SLE. Anti-DNA autoantibodies can bind with ANXA2 expressed on mesangial cells in lupus nephritis. Besides, a french study carried out in Amiens' University Hospital showed that vascular lesions in lupus nephritis were associated with a significant increase in vascular expression of ANXA2.

NCT ID: NCT03021499 Completed - Lupus Nephritis Clinical Trials

Aurinia Renal Response in Active Lupus With Voclosporin

AURORA
Start date: May 17, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy of voclosporin compared with placebo in achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis.

NCT ID: NCT02949973 Completed - Lupus Nephritis Clinical Trials

Aurinia Early Urinary Protein Reduction Predicts Response

AURION
Start date: June 2015
Phase: Phase 2
Study type: Interventional

An exploratory study assessing the ability of biomarkers measured at 8 weeks to predict clinical response over 24 and 48 weeks in subjects taking voclosporin 23.7 mg twice daily (BID) in combination with standard of care in patients with active lupus nephritis

NCT ID: NCT02949349 Completed - Lupus Nephritis Clinical Trials

Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis

Start date: July 2015
Phase: Phase 2
Study type: Interventional

This study is designed to compare the safety and efficacy of Mycocep Capsules (Mycophenolate Mofetil) and a marketed Azathioprine formulation, Imuran Azathioprine Tablets, in the maintenance therapy of lupus nephritis.

NCT ID: NCT02770170 Completed - Lupus Nephritis Clinical Trials

Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis

Start date: May 16, 2016
Phase: Phase 2
Study type: Interventional

The overall purpose of the study is to assess the efficacy of three different doses of BI 655064 against placebo as add-on therapy to standard of care (SOC) treatment for active lupus nephritis in order to characterize the dose-response relationship within the therapeutic range, and select the target dose for phase III development.

NCT ID: NCT02645565 Completed - Lupus Nephritis Clinical Trials

Comparison of Low Dose Versus High Dose Cyclophosphamide as Induction Therapy in the Treatment of Lupus Nephritis

Start date: December 2015
Phase: Phase 4
Study type: Interventional

This study will be conducted to find out whether low dose or high dose cyclophosphamide therapy is effective in the treatment of proliferative lupus nephritis.It will also compare the side effects and risks of infection in low dose and high dose cyclophosphamide group. Half of the participants will receive a low dose cyclophosphamide for 3 months and half will receive high dose cyclophosphamide therapy monthly for 6 months followed by azathioprine 2 mg/kg.