Lupus Nephritis

Researchers are studying pulmonary arterial hypertension (PAH), including its common subtypes idiopathic PAH (IPAH) and connective tissue disease-associated PAH (PAH-CTD). The study aims to develop pulmonary vascular biomarker signatures using hyperpolarized 129Xe MRI to differentiate these subtypes and to evaluate the ability of this imaging to monitor disease progression and treatment response over time. Additional assessments such as laboratory tests, echocardiography, and six-minute walk distance (6MWD) are also used to support these evaluations. The study is observational and enrolls 20 subjects divided into two groups: 10 with IPAH and 10 with PAH-CTD. Participants will undergo hyperpolarized 129Xe MRI and MR spectroscopy at baseline, 3 months, 6 months, and 12 months. Alongside imaging, data from standard clinical assessments including labs, echocardiography, and 6MWD will be collected at these same timepoints to track changes. Participants will be monitored for changes in pulmonary vascular remodeling, red blood cell oscillation amplitude, 6MWD, NTproBNP levels, and WHO functional class over one year. Safety is assessed by tracking adverse events, serious adverse events, withdrawals, and specific examinations such as electrocardiograms and vital signs. The total follow-up period for each participant is one year, with multiple scheduled evaluations to comprehensively assess disease status and response.

Researchers are evaluating whether using an automated Carbon Dioxide (CO2) injection system during infrainguinal peripheral vascular interventions (PVI) can reduce major adverse kidney events within 90 days in patients at moderately increased risk for contrast-associated acute kidney injury (CA-AKI). This Phase 3 randomized controlled trial compares a CO2-based contrast medium sparing strategy to the standard use of iodinated contrast media in patients with peripheral vascular and kidney diseases. Participants are randomly assigned to one of two groups. The intervention group receives PVI using an automated CO2 injection system as the primary contrast agent, with iodinated contrast media available as a backup if image quality is insufficient or if the patient cannot tolerate CO2 angiography. The control group undergoes routine PVI using iodinated contrast media according to local standards, avoiding high-osmolar contrast agents. All patients are followed for up to 12 months after their procedure. During the study, participants undergo the planned PVI procedure with either contrast method. Researchers carefully record the amount and reasons for any iodinated contrast media used in the CO2 group. Patients are monitored for kidney-related outcomes, focusing on major adverse kidney events up to 90 days after the intervention. The trial includes ongoing follow-up assessments to evaluate safety and effectiveness over one year.

This research focuses on people who have previously been treated with KYV-101, an autologous CAR T cell therapy, to monitor long-term safety and persistence of the treatment. It aims to collect information about delayed side effects and ongoing presence of the gene-modified cells in participants who received at least one infusion of KYV-101 in earlier clinical trials sponsored by Kyverna Therapeutics. Participants in this observational study will continue to be followed for up to 15 years after their initial KYV-101 treatment. The study will track various health outcomes including treatment-related adverse events, new or returning malignancies, neurological and autoimmune conditions, blood disorders, infections, and specific laboratory tests related to the therapy. For some participants with certain conditions, additional measures like medication use and functional assessments will be monitored for shorter periods. Throughout the study, participants will undergo regular health evaluations, lab tests, and questionnaires to assess the long-term effects of KYV-101. Researchers will collect data on safety events and laboratory markers up to 15 years, with some specific tests monitored up to 5 years. The overall goal is to better understand the long-term impact and safety profile of the gene-modified therapy in people treated previously.

This research focuses on kidney transplant patients to collect blood samples and clinical data for developing a non-invasive test that detects donor-derived cell-free DNA (dd-cfDNA) to assess the condition of transplanted kidneys. The study is prospective and multicenter, involving participants who have had a kidney transplant and are undergoing an indication biopsy. The goal is to improve monitoring of the transplanted organ's status. Participants will provide whole blood samples at the time of their indication biopsy, before the biopsy procedure itself. Additionally, leftover de-identified retrospective genomic DNA (gDNA) samples from the kidney donors will be collected for paired analysis. This approach helps researchers study dd-cfDNA in a real-world transplant population. Participants will be involved through blood sample collection and clinical data gathering during their biopsy visits. Researchers will monitor the detection of donor-derived cell-free DNA in whole blood over an 18-month period. The study involves no investigational treatments, focusing on observation and sample analysis. Participation duration and follow-up details align with the biopsy schedule and sample collection requirements.

Researchers are evaluating VENT-03, an oral tablet, to treat adults with active cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). The study aims to understand if VENT-03 affects CLE activity and severity, assess its safety, and learn how the body processes the drug. This Phase 2a trial compares VENT-03 to a placebo to determine its effects on the skin's interferon gene signature and disease severity. Participants will be randomly assigned to receive either VENT-03 or a placebo tablet daily for 4 weeks during a double-blind period. After this, all participants will take VENT-03 for an additional 8 weeks in an open-label extension. Clinic visits will occur monthly for checkups, tests, and to monitor treatment effects and side effects. During the study, participants will undergo skin biopsies and lab tests to evaluate immune markers and drug levels in the body. Researchers will track disease severity changes and record any side effects or adverse events throughout the 12-week treatment period. Safety assessments and drug concentration measurements will be done at set times to understand how VENT-03 is absorbed and tolerated.

Researchers are evaluating FT819, an investigational drug, in a phase 1 study for people aged 12 to 70 with moderate-to-severe active B-cell mediated autoimmune diseases. These conditions include systemic lupus erythematosus (SLE) with or without nephritis, antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc). The study aims to assess the safety, how the drug is processed in the body, and its effect on B cells. The trial is sponsored by Fate Therapeutics and includes a dose-escalation stage followed by an expansion stage to further evaluate safety and activity. Participants will receive FT819 through intravenous (IV) infusion at planned dose levels. The study includes several treatment regimens, some using FT819 with an auxiliary medicinal product (AMP) and some without, combined with background therapies or temporarily suspending them. Other drugs such as fludarabine, cyclophosphamide, and bendamustine may also be administered as IV infusions at planned dose levels. The trial is non-randomized and open-label, with different dosing schedules including single or two-dose regimens. Participants will be closely monitored for treatment-emergent adverse events and dose-limiting toxicities up to approximately two years. Researchers will measure the plasma concentration of FT819, disease activity, and quality of life at designated time points. Safety assessments and evaluations of disease activity, including lupus nephritis when applicable, will be conducted throughout the study. The total participation time may extend up to two years to gather comprehensive safety and activity data.

Researchers are evaluating the safety and tolerability of NKX019, an investigational allogeneic CD19-directed CAR NK cell therapy, in adults with autoimmune diseases such as Lupus Nephritis and Primary Membranous Nephropathy. This Phase 1/2, open-label, multi-center study uses a dose escalation design to find recommended doses and assess preliminary effects, pharmacokinetics, and pharmacodynamics. Participants undergo a treatment cycle starting with lymphodepletion using fludarabine and cyclophosphamide or cyclophosphamide alone if cytopenic, followed by three doses of NKX019. The study uses a "3+3" dose escalation to determine safe dosing and includes dose expansion cohorts. The treatment aims to evaluate the impact of NKX019 on autoimmune disease activity and kidney function. During the study, participants are closely monitored for dose-limiting toxicities, adverse events, and lab abnormalities from the first dose until follow-up. Researchers assess kidney response, disease activity scores, and drug levels in blood for up to two years after infusion. Immunogenicity and effects on background therapies are also evaluated. The total participation time varies based on follow-up assessments and treatment response.

Researchers are conducting a prospective national registry in Denmark to observe and collect data on percutaneous transluminal renal angioplasty (PTRA) in patients who have high-risk renovascular hypertension. This registry includes patients selected based on common national criteria and follows a standardized protocol across three Danish centers offering PTRA. The study aims to evaluate changes in blood pressure and other health outcomes after the procedure. The intervention being studied is percutaneous transluminal renal angioplasty, including angioplasty with stenting, especially in patients with fibromuscular dysplasia. Additional treatments such as antiplatelet therapy, cholesterol-lowering drugs, antihypertensive medications, and lifestyle measures like smoking cessation, diet, and physical activity are used according to the physician's discretion. The study monitors patients over time following their PTRA treatment. Participants undergo regular assessments including 24-hour ambulatory blood pressure monitoring and kidney function tests. The primary outcome measured is the change in systolic and diastolic blood pressures 24 months after PTRA in patients with elevated baseline blood pressure. Secondary outcomes include blood pressure changes at multiple time points, adjustments in antihypertensive treatment, kidney function changes, clinical and safety endpoints. Follow-up evaluations occur up to 60 months post-treatment to monitor long-term effects and safety.

Researchers are evaluating the long-term effects of enavogliflozin, a new sodium-glucose cotransporter-2 (SGLT2) inhibitor, in adults aged 19 and older with type 2 diabetes who have or are at risk for cardiovascular disease. This study aims to determine if enavogliflozin is not less effective than other SGLT2 inhibitors like dapagliflozin or empagliflozin in reducing major heart and kidney problems. The trial is a multicenter, randomized, open-label, active-controlled, non-inferiority study focusing on cardiorenal outcomes in the Korean population. Participants will be randomly assigned to receive enavogliflozin or either dapagliflozin or empagliflozin, with the dosing and administration guided by the investigator based on approved use and the participant's medical condition. The study includes an initial treatment period with follow-up assessments up to 48 months to monitor outcomes. The primary measurement is the time to the first major heart or kidney event, while secondary outcomes include rates of heart attacks, hospitalizations, deaths, kidney events, and progression of kidney damage. During the study, participants will have regular evaluations at 6, 12, 24, 36, and 48 months to assess cardiovascular and kidney health. Researchers will monitor hospitalizations, deaths, and kidney function changes using clinical records and laboratory tests. This long-term follow-up aims to clarify the role of enavogliflozin in preventing vascular complications in patients with type 2 diabetes and cardiovascular risk factors, with safety and outcomes carefully tracked throughout the study period.

Researchers are evaluating cenerimod combined with regular treatment to see if it improves kidney function and is safe for adults with systemic lupus erythematosus (SLE) who have active lupus nephritis. The study is a Phase 3 clinical trial comparing cenerimod with a placebo to understand its effects on kidney health and potential medical problems during treatment. Participants will take either cenerimod or a placebo once daily for about 76 weeks (1.5 years) alongside their usual lupus nephritis therapy, which includes medications like mycophenolate mofetil and corticosteroids. The trial is designed as a double-blind, randomized study with two groups: one receiving cenerimod and the other a matching placebo. During the study, participants will visit the clinic every 1 to 3 months for checkups and tests. Researchers will measure kidney response at week 76 and monitor safety throughout the trial. The main outcome is complete renal response, which assesses kidney function improvement. Participants will be closely monitored for side effects and adherence to treatment during the entire study period.