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Nephritis clinical trials

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NCT ID: NCT05916781 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Effectiveness of Mycophenolate Mofetil Combined With Tacrolimus for Steroid Tapering in Systemic Lupus Erythematosus

Start date: July 1, 2023
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to determine whether mycophenolate mofetil(MMF) combined with tacrolimus(TAC) can maintain remission in patients with lupus nephritis (LN) who have reached treatment targets after steroid tapering. The main question[s] it aims to answer are: - The efficacy, safety and tolerability of MMF combined with TAC regimen in the treatment of LN patients in the maintenance period. - The influence of low-dose steroid on carotid intima thickness (CIMT). - The omics and cell-free RNA (cfRNA) spectral differences related to lupus flare. - The differences in health economics between steroid tapering and steroid maintenance patients. Participants will be randomly assigned into 2 groups. In the steroid tapering group, participants will take MMF+TAC treatment without steroid for 1 year, and participants who stop steroid treatment without lupus flare will be randomly assigned to monotherapy with MMF or TAC. In the steroid maintenance group, participants will take MMF+TAC+steroid for 1 year, and participants without lupus flare will be randomly assigned to therapy with MMF + steroid or TAC + steroid.

NCT ID: NCT05863936 Recruiting - Safety Issues Clinical Trials

Trial of Belimumab Combined With Multi-target Induction Therapy in Lupus Nephritis

BEAM
Start date: April 1, 2023
Phase: Phase 3
Study type: Interventional

The goal of this single-center, prospective clinical trial is to test the safety and efficacy of belimumab combined with multi-target therapy in the treatment of severe lupus nephritis. The main questions it aims to answer are: lupus nephritis complete remission rate at week 24, and the partial remission rate and safety assessments. Patients with severe lupus nephritis will be enrolled and received pulse methylprednisolone at a dose of 1.5 to 3.0g, followed by intravenous belimumab at a dose of 10mg per kilogram at weeks 2, 4, and 6, and every 4 weeks thereafter. Multitarget therapy will be also administered during the induction phase. Induction therapy will last for 24 weeks. Patients with severe lupus nephritis who only received multi-target therapy during the same period will be enrolled as the control group.

NCT ID: NCT05845151 Recruiting - Lupus Nephritis Clinical Trials

Fibroblast Activating Protein Inhibitor PET Imaging in Lupus Nephritis

Start date: May 1, 2021
Phase: N/A
Study type: Interventional

Abnormal high expression of fibroblast activating protein (FAP) has been found in inflammatory reactions and benign fibrosis tissue. Autoimmune nephropathy such as lupus nephritis (LN) can lead to tubular atrophy and excessive deposition of extracellular matrix, which may be accompanied by abnormally increased expression of activated FAP in kidney tissue, and lead to renal fibrosis and long-term renal failure. This makes 68Ga-labeled FAP inhibitor (FAPI) positron emission tomography (PET) imaging the potential to early assess disease severity, predict disease progress and aid treatment planning in patients with LN. Compared to renal pathological puncture, 68Ga-FAPI PET is a new tool for non-invasive, repeatable assessment of renal fibrotic activation.

NCT ID: NCT05810948 Recruiting - Lupus Nephritis Clinical Trials

A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients With Lupus Nephritis (ZL-1103-013)

Start date: February 21, 2023
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy and safety of efgartigimod IV in Chinese patients with active lupus nephritis (LN)

NCT ID: NCT05798117 Recruiting - Clinical trials for Systemic Lupus Erythematosus

An Open-label, Study to Assess Safety, Efficacy and Cellular Kinetics of YTB323 in Severe, Refractory Systemic Lupus Erythematosus

Start date: February 28, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The study is intended to assess safety, efficacy and cellular kinetics of YTB323 treatment in participants with severe refractory systemic lupus erythematosus.

NCT ID: NCT05781750 Recruiting - Lupus Nephritis Clinical Trials

A Study of Zetomipzomib (KZR-616) in Patients With Active Lupus Nephritis (PALIZADE)

Start date: November 3, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of zetomipzomib (30 mg or 60 mg) compared with placebo in achieving renal response after 52 weeks of treatment in patients with active lupus nephritis (LN).

NCT ID: NCT05780515 Recruiting - Lupus Nephritis Clinical Trials

A Study of ANX009 in Adult Participants With Lupus Nephritis

Start date: August 9, 2022
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to determine the safety and tolerability of repeat doses of ANX009 in participants with lupus nephritis (LN).

NCT ID: NCT05748925 Active, not recruiting - Lupus Nephritis Clinical Trials

Cardio Renal Effects of SGLT2 Inhibitors Among Lupus Nephritis Patients

Start date: October 1, 2022
Phase: Phase 4
Study type: Interventional

This study aims to assess sodium glucose linked transoprter inhibitors(SGT2i) role in regression of ongoing kidney and cardiac diseases among lupus nephritis patient either diabetic or non-diabetic under different immunosuppressive therapy. The main objective of this study is to: To compare use of sodium glucose linked transoprter inhibitors (SGLT2i) versus standard care in regression of chronic kidney disease in patient with lupus nephritis (LN). To study the safety and efficacy of this drug group with use of immunosuppression and possible interaction. Patients with an estimated glomerular filtration rate (eGFR) >30 ml/min/1.73m2 will be randomized into two groups Study group will receive SGLT2i inhibitor as add on drug or replace another drug according to patient clinical situation, Dapagliflozin 10 mg and 25 mg will be used once daily with or without food. Control group will be maintained on placebo.We will follow up all patients for 12 months and compare their results.

NCT ID: NCT05732402 Recruiting - Lupus Nephritis Clinical Trials

An Open-label Study of Povetacicept (ALPN-303) in Autoimmune Kidney Diseases

RUBY-3
Start date: March 15, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical study is to evaluate multiple dose levels of povetacicept (ALPN-303) in adults with immunoglobulin A (IgA) nephropathy, membranous nephropathy, lupus-related kidney disease (lupus nephritis). or anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis to determine if povetacicept is safe and potentially beneficial in treating these diseases. During the study treatment period, participants will receive povetacicept approximately every 4 weeks for 6 months, with the possibility of participating in a 6-month treatment extension period and an optional 52 week treatment extension period.

NCT ID: NCT05714670 Recruiting - Lupus Nephritis Clinical Trials

The Effect of Curcumin on the Clinical Outcome of Pediatric Patients With Active Lupus Nephritis

Start date: April 1, 2023
Phase: Phase 2
Study type: Interventional

Pediatric 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