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ANCA-associated Vasculitis clinical trials

View clinical trials related to ANCA-associated Vasculitis.

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NCT ID: NCT06285279 Recruiting - Lupus Nephritis Clinical Trials

FKC288 in Participants With Autoimmune Kidney Diseases

Start date: March 15, 2024
Phase: Phase 1
Study type: Interventional

This study is a single-center, open-label, dose-escalation exploratory clinical trial, expected to enroll 6 to 12 participants. It will use a BOIN (Bayesian Optimal Interval) design for dose escalation, with four predetermined dose groups (0.3×10^6 cells/kg, 1.0×10^6 cells/kg, 3.0×10^6 cells/kg, and an alternative dose of 0.1×10^6 cells/kg). Each dose group plans to enroll 1-2 or 3-6 participants with relapsed or refractory autoimmune-mediated kidney diseases (such as lupus nephritis, ANCA-associated vasculitis, membranous nephropathy, and IgG4-related diseases).

NCT ID: NCT06277427 Recruiting - Lupus Nephritis Clinical Trials

Refractory ANCA Associated Vasculitis and Lupus Nephritis Treated With BCMA-targeting CAR-T Cells

Start date: February 5, 2024
Phase: N/A
Study type: Interventional

Lupus nephritis (LN) and ANCA-associated vasculitis are severe autoimmune diseases, which may lead to the death of patients, particularly when they are refractory to the conventional therapeutic agents. Based on the current knowledge, the autoantibodies against self-antigens may exert important pathological roles in the pathogenesis of both LN and ANCA-associated vasculitis, of which the origins are primarily plasmablasts and plasma cells. BCMA is the molecule expressed on memory B cells, plasmablasts and plasma cells, and therefore is an ideal target for the elimination of potential pathogenic antibody secreting cells. Chimeric antigen receptor (CAR) T cells against BCMA may provide a novel therapeutic way for the refractory LN and ANCA-associated vasculitis patients to eliminate the pathogenic autoantibody-secreting cells. In this study, the safety and efficacy of a novel CAR-T cell therapy using PRG-1801 cells, are evaluated in patients with refractory LN and ANCA-associated vasculitis.

NCT ID: NCT06152172 Not yet recruiting - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

CARTIMMUNE: Study of Patients With Autoimmune Diseases Receiving KYV-101

CARTIMMUNE
Start date: February 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety, tolerability, and clinical activity of KYV 101 (a fully-human anti-CD19 CAR T-cell therapy) in adult subjects with B cell-driven autoimmune diseases. The trial anticipates enrolling participants to reach a maximum of 24 participants who will receive 1 dose of KYV-101 and will be followed for 2 years.

NCT ID: NCT05965284 Recruiting - Clinical trials for ANCA-associated Vasculitis

Efficacy and Safety for Telitacicept in the Remission Maintenance Treatment of ANCA-associated Vasculitis (TTCAZAREM)

Start date: March 9, 2023
Phase: Phase 4
Study type: Interventional

This study is a prospective, open-labelled, randomized, controlled, single-center clinical trial. The aim of this study is to compare the remission rate of patients treated with Telitacicept combined with azathioprine and azathioprine alone in remission-maintenance treatment of AAV.

NCT ID: NCT05962840 Recruiting - Clinical trials for ANCA Associated Vasculitis

Efficacy and Safety for Rituximab Combined With Telitacicept in the Treatment of ANCA-associated Vasculitis (TTCAAVREM)

Start date: June 29, 2023
Phase: Phase 4
Study type: Interventional

This study is a prospective, open-labelled, randomized, controlled, single-center clinical trial. The aim of this study is to investigate the remission rate of patients treated with Telitacicept combined with Rituximab in remission-induction and Telitacicept alone in remission-maintain treatment.

NCT ID: NCT05946564 Not yet recruiting - Clinical trials for ANCA Associated Vasculitis

A Trial to Evaluate the Efficacy of Pioglitazone to Promote Renal Tolerance in ANCA-associated Vasculitis - RENATO Trial

RENATO
Start date: July 2023
Phase: Phase 3
Study type: Interventional

The RENATO trial is a multicenter randomized controlled trial that evaluates the efficacy of pioglitazone to improve renal outcomes in ANCA-associated vasculitis. Patients with biopsy-proven kidney involvement of ANCA vasculitis will be included in this trial at diagnosis. All patients will receive a standard of care immunosuppressive (SOC) therapy combining corticosteroids and rituximab (375 mg/m2/week for 4 consecutive weals followed by 500 mg re-infusion every 6 months). They will be randomized 1:1 to receive either pioglitazone 30 mg/day or placebo for 6 months, on top of SOC. The primary objective of this trial is to demonstrate that pioglitazone reduces kidney damage, reflected by the early improvement of proteinuria and serum creatinine levels. The secondary objectives will be to assess the efficacy of this drug on the reduction of hypertension and metabolic effects of glucocorticoids, to measure its impact on vasculitis activity and to evaluate the safety profile of pioglitazone in this population.

NCT ID: NCT05897684 Recruiting - Clinical trials for ANCA-associated Vasculitis

Avacostar - (PASS)

Avacostar
Start date: September 11, 2023
Phase:
Study type: Observational

The Avacostar PASS is a non-interventional, multi-national, prospective cohort study that will collect data from 2 cohorts of patients: those treated with avacopan for active severe AAV, and a second cohort treated with a cyclophosphamide or rituximab-based induction regimen without avacopan for active severe AAV. The overall study duration is anticipated to be up to 7 years, including a recruitment period of approximately 3 years.

NCT ID: NCT05716334 Active, not recruiting - Clinical trials for Microscopic Polyangiitis

Biosimilars of Rituximab in ANCA-associated Vasculitis Compared to the Originator

BRAVO
Start date: June 15, 2021
Phase:
Study type: Observational

The goal of this multicentre observational study is to compare the safety and effectiveness of rituximab biosimilars to the originator in Canadian patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA), two main forms of ANCA-associated vasculitis (AAV). The main questions it aims to answer are: - Is there a difference in vasculitis control between originator and biosimilar rituximab? - Is there a difference in adverse effects between originator and biosimilar rituximab? - In the Canadian healthcare context, are wait times to receive approval (financial coverage) for rituximab shorter for biosimilars compared to originators? Investigators will perform study assessments (including recording disease activity, damage, and adverse events) at the time of participants' usual clinical care visits, at regular intervals for 2 years after starting rituximab (for induction or maintenance treatment) or switching from an originator to a biosimilar as part of their usual care. Researchers will compare outcomes among participants who have received rituximab originators (from 2018 onwards) or biosimilars as part of their usual care, to see if there are differences in relapses, remission rates, damage, serious infections, serious adverse events, and treatment approval wait times.

NCT ID: NCT05630612 Recruiting - Clinical trials for Cardiovascular Diseases

ETA and AT1 Antagonism in ANCA-vasculitis (SPARVASC)

SPARVASC
Start date: December 8, 2022
Phase: Phase 2
Study type: Interventional

ANCA-associated vasculitis is an autoimmune disease that causes damage to blood vessels. This leads to organ damage with the number of organs affected and the severity of damage varying significantly between patients. Vasculitis patients also have a very high risk of heart attacks and strokes, called cardiovascular disease. A chemical called 'endothelin', produced by the blood vessels, causes vessels to stiffen and raises blood pressure and this associates with cardiovascular risk. The investigators have previously shown that by blocking the effects of endothelin you reduce vessel stiffness, lower blood pressure and improve vessel function. However, these studies only blocked endothelin for a few hours. Now, the investigators would like to see if it is possible to maintain these benefits by blocking endothelin for longer. Sparsentan is a tablet that blocks endothelin and lowers blood pressure. The investigators plan to give sparsentan to patients with vasculitis for 6 weeks. To determine if any beneficial effects of sparsentan are due to blood pressure lowering the investigators will give another group of vasculitis patients a tablet called irbesartan which lowers blood pressure but does not block endothelin. The investigators will compare the results between the two groups.

NCT ID: NCT05416723 Not yet recruiting - Clinical trials for Environmental Exposure

Occupational and Environmental Origins of ANCA Vasculitis: Contribution of Data From the National Network for Vigilance and Prevention of Occupational Pathologies (RNV3P)

ANCAPRO
Start date: July 1, 2022
Phase:
Study type: Observational

The main objective is to identify specific risk factors for ANCA vasculitis of occupational and/or environmental origin (exposures identified by questioning, geographical distribution of cases) from the RNV3P data. The secondary objectives are as follows: - Description of cases of ANCA vasculitis seen in French occupational pathology consultation centres: - reasons for consultation, - occupational and environmental etiologies described - occupational situations responsible - aptitude notices - recognition as an occupational disease - Identification of specific risk factors for ANCA vasculitis of occupational and/or environmental origin (exposures identified on questioning, geographical distribution of cases). - For occupational and non-occupational cases of ANCA vasculitis: identification of difficulties encountered by patients at work and proposed work adaptations. - Estimation of the number of applications for recognition of disabled worker status made within this patient group. - Identification of clinical severity and autoimmune profiles of ANCA vasculitis of occupational and/or environmental origin.