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Lupus Nephritis clinical trials

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NCT ID: NCT04971590 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Study to Assess Demographic, Pharmacologic, Biomarker, Clinical Features and Quality of Life (QoL) of Participants With Lupus Nephritis

Start date: September 14, 2021
Phase:
Study type: Observational

This is a multicenter prospective study to assess clinical characteristics, demographics, treatment and health-related quality of life (HRQoL) of lupus nephritis (LN) participants across 5 Gulf countries (United Arab Emirates [UAE], Qatar, Bahrain, Kuwait and Oman).

NCT ID: NCT04894695 Recruiting - Lupus Nephritis Clinical Trials

Urine Exosomes to Identify Biomarkers for LN

Start date: August 2, 2020
Phase:
Study type: Observational

Urine exosomes will be extracted from patients with lupus nephritis, healthy controls, and patients with systemic lupus erythematosus without lupus nephritis. Transcriptome and/or metabonomics sequencing of exosomes will be performed to screen for molecules in the urine exosomes of patients with lupus nephritis that are significantly different from those of the other groups.

NCT ID: NCT04870359 Recruiting - Lupus Nephritis Clinical Trials

Pre-emptive Treatments in Lupus Nephritis Patients With Serological Reactivation

Start date: April 21, 2016
Phase: N/A
Study type: Interventional

The optimal management of asymptomatic serological reactivation (ASR) in lupus nephritis (LN) patients remained undefined. This project aims to investigate the impact of pre-emptive treatment on disease relapse in LN patients who experienced ASR.

NCT ID: NCT04868838 Recruiting - Lupus Nephritis Clinical Trials

Daratumumab to Treat Active Lupus Nephritis

Start date: April 20, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this research is to study the safety and efficacy of daratumumab in inducing complete or partial remission in patients with active lupus nephritis.

NCT ID: NCT04835883 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Exploring the Efficacy and Safety of CS20AT04 (Allogenic Bone Marrow-Derived Stem Cell) in Systemic Lupus Erythematosus Patients

Start date: September 26, 2019
Phase: Phase 2
Study type: Interventional

This is an open-label, one-arm single-center phase Ⅱa study exploring the efficacy and safety of CS20AT04 (HLA-haplo Matched Allogenic Bone Marrow-Derived Stem Cells) in two subpopulation group of systemic lupus erythematosus patients - lupus nephritis and lupus cytopenia.

NCT ID: NCT04702256 Recruiting - Lupus Nephritis Clinical Trials

Induction Therapy for Lupus Nephritis With no Added Oral Steroids: A Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMF

OBILUP
Start date: December 9, 2021
Phase: Phase 3
Study type: Interventional

This is a randomised, open label, controlled non-inferiority phase III multicentre trial. As primary objective, the study aims to demonstrate that a regimen free of additional oral corticosteroids but with obinutuzumab (and MMF) is non-inferior to a regimen based on oral corticosteroids and MMF in achieving the primary outcome of complete renal response at week 52 without receiving corticosteroids above a prespecified dose. As secondary objectives, the study aims: - To compare the efficacy of the treatments in both arms in terms of: - partial plus complete renal response at week 52; - proteinuria < 0.8g/g at week 52; - extrarenal flares; - response as defined by a >4 points reduction in SELENA-SLEDAI score at week 52. - To compare the safety of the treatments in both arms in terms of occurrence of: - toxicity of corticosteroids; - serious Adverse Events; - serious Infectious Episodes; - new damage. - To compare the number of patients with non-adherence to treatment in both arms. - To estimate the efficiency of obinutuzumab in this indication. The ancillary studies will allow: - To implement a biobank (serum, plasma, DNA, cells and urine) and a bank of renal biopsies for studies that will be part of separate research funding bids (patients will be informed that their samples and data may be used for subsequent studies and offered to consent or not). - To identify which target therapeutic levels of MMF best predicts response with least toxicity (ancillary study). - To have long term data on renal function and damage.

NCT ID: NCT04648059 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Epigenetics in Lupus Nephritis

Epi_LN
Start date: December 1, 2020
Phase:
Study type: Observational

This is a translational study for the identification of epigenetic changes detectable in sera of patients suffering from Systemic Lupus erythematosus. The aim of the study is to analyze whether circulating DNA fragments are 1) different in patients with or without Lupus nephritis and 2) present and detectable in the circulation before the development of Lupus nephritis.

NCT ID: NCT04645589 Recruiting - Lupus Nephritis Clinical Trials

Evaluating the Safety of Myfortic (Mycophenolate Sodium) in Patients With Lupus Nephritis

Start date: March 16, 2021
Phase:
Study type: Observational

This is an open-label, prospective, single-arm, observational study in patients with Lupus nephritis (LN) who newly (i.e.,for the first time) received treatment of Enteric-coated Mycophenolate Sodium (EC-MPS).

NCT ID: NCT04564339 Recruiting - Lupus Nephritis Clinical Trials

Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)

SANCTUARY
Start date: December 11, 2020
Phase: Phase 2
Study type: Interventional

The objectives of this study are to evaluate the safety and efficacy of ravulizumab administered by intravenous (IV) infusion compared to placebo and demonstrate proof-of-concept of the efficacy of terminal complement inhibition in participants with LN (LN Cohort) or IgAN (IgAN Cohort).

NCT ID: NCT04534647 Recruiting - Lupus Nephritis Clinical Trials

Serological and Urinary Biomarkers in Latin American Patients With Systemic Lupus Erythematosus: GLADEL 2.0 Cohort

Start date: June 1, 2019
Phase:
Study type: Observational

Lupus nephritis (LN) is one of the main manifestationsin SLE patients, having an important impact on morbidity and mortality. Renal biopsy is the "gold standard" for the diagnosis of LN, however, it is an invasive technique, not free of complications,which is not recommended to be performed serially as a follow-up tool for patients with LN. Searching for biomarkers in SLE has been the subject of interesting research, although results have not always been relevant. Multiple biomarkers have been studied in different locations (soluble markers in blood, urine and biological fluids),of different nature(autoantibodies, genetic markers of "kidney damage") looking atdiagnostic and/orprognostic features. In recent years, several biomarkers have been developed that seek to find an association with pathological patterns, with pathogenic mechanisms and with a non-invasive diagnosis of different glomerulopathies, allowing the identification of prognostic subgroups in each type of kidney disease, while predicting response to treatment and/or recurrence. To date, double-stranded anti-DNA antibodies (anti-dsDNA) and serum complement are the only non-invasive routine biomarkers for monitoring renal activity in patients with LN. However, these markers are only the reflection of the immune activity of the disease and they are not markers of renal damage or poor prognosis. For all the above, the purpose of this study is, in a case-control study, to evaluate simultaneously serum (ANA, anti-dsDNA, anti-C1q, anti-cardiolipin IgG and IgM, anti-ß2GPI IgG and IgM, anti-phosphatidylserine/prothrombin antibodies, and anti-DFS70 antibodies) and urinary biomarkers, and the presence of anti-DFS70 antibodies, in a multiethnic cohort of patients with SLE such as the cohort of GLADEL, and assess its possible correlation with various socio-demographic, clinical and serological manifestations of the disease. In subgroup of patients, transcriptome studies will be performed using RNA from blood and tissue to identify possible transcriptional signatures.