Glomerulonephritis

Researchers are evaluating the safety and effectiveness of a drug called B007 compared to cyclosporine in treating adults with primary membranous nephropathy, a kidney condition. This study is a multicenter, randomized, controlled, open-label trial conducted in phases II and III to better understand treatment options for this disease. Participants will be randomly assigned to receive either B007 or cyclosporin capsules. B007 is given by subcutaneous injection on days 1 and 15, while cyclosporin capsules are taken orally at a dose of 3.5 mg per kg of body weight per day. The study will observe participants over about two years to assess remission rates and monitor safety. During the trial, participants will undergo laboratory tests and assessments to track overall, complete, and partial remission rates. Researchers will also monitor any treatment-emergent adverse events or serious side effects. Participants must meet specific kidney function criteria and will be followed closely throughout the study period until its completion in late 2026.

Researchers are evaluating the efficacy and safety of BAT4406F injection in adults aged 18 to 75 years diagnosed with Minimal Change Disease or Focal Segmental Glomerulosclerosis. This phase IIIII, multicenter, randomized, double-blind, placebo-controlled study aims to better understand how this treatment may impact these kidney conditions, which cause nephrotic syndrome and respond to corticosteroid therapy. Participants will be randomly assigned to receive one of three treatments a single-dose BAT4406F every six months, a double-dose BAT4406F every six months, or a placebo. In Phase II, dosing involves a single dose on Day 1 or doses on Day 1 and Day 15. In Phase III, the dosing schedule depends on Phase II results and may include doses on Day 1, Day 15, Day 182, and Day 196. All doses are administered by intravenous infusion. During the study, participants will undergo assessments to monitor kidney function, disease remission status, and safety over 26 weeks in Phase II and 52 weeks in Phase III. Researchers will measure effectiveness indicators and monitor for side effects. The study includes careful screening and follow-up visits, with the total participation lasting up to 52 weeks depending on the phase.

Researchers are evaluating CPV-104, a new medicine designed to regulate the complement system, which can be overactive in diseases such as C3 glomerulopathy C3G, a very rare kidney disorder. This phase 1 trial is the first time CPV-104 is being tested in people, including both healthy adults and adults with C3G, to assess its safety, tolerability, how the body processes the medicine, and whether the immune system reacts to it. The study has two parts Part 1 involves healthy volunteers receiving a single intravenous dose of CPV-104 or a placebo in a randomized, double-blind manner across several dose levels. Part 2 includes patients with C3G receiving four weekly intravenous doses of CPV-104 without placebo. Doses are escalated if the medicine is tolerated, and a Safety Review Committee regularly reviews results to ensure safety before progressing. Participants will undergo close monitoring throughout the study, including side-effect checks, blood and urine tests, ECGs, vital signs, and blood samples to measure drug levels and antibodies. For C3G patients, kidney function will also be observed. The primary outcome is the incidence of severe and serious adverse drug reactions up to Day 29 for healthy volunteers and Day 50 for C3G patients. The total study duration varies by part, with detailed safety assessments conducted throughout.

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.

Researchers are studying the safety, tolerability, pharmacokinetics PK, and pharmacodynamics PD of HS-10390 in healthy adults aged 18 to 45 years. This Phase 1 trial aims to understand how the drug behaves in the body and how well it is tolerated when taken in different doses. The study specifically involves healthy volunteers to gather initial data before testing in patients with conditions like IgA Nephropathy or Focal Segmental Glomerulosclerosis. The study uses a randomized, double-blind, placebo-controlled design with single and multiple ascending dose SAD and MAD periods. There will be about six sequential groups for single doses and three for multiple doses. Participants will receive oral tablets of HS-10390 or a matching placebo while fasting. The multiple dose phase begins after safety and PK data from the single dose phase are reviewed. A sentinel dosing approach is used in the first single dose group to enhance safety. Participants will be monitored from Day 1 up to Day 12 for single doses and up to Day 28 for multiple doses. Researchers will assess adverse events, serious adverse events, and any events leading to stopping the study drug. They will also measure drug levels in the blood over time to understand how quickly and extensively the drug is absorbed, distributed, and cleared. Safety checks include physical exams, lab tests, vital signs, ECGs, and imaging as needed. The total study duration varies by participant depending on the dosing schedule and monitoring requirements.

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.

Researchers are conducting a prospective, observational study to understand the full range of symptoms, treatment use, and overall quality of life experienced by patients with Immunoglobulin A nephropathy IgAN and their caregivers. The study aims to capture detailed data on these aspects over time to better reflect the patient experience and treatment patterns in the US. Participants will use the Folia Health mobile platform to enroll and provide data. The study includes IgAN patients taking different treatments such as iptacopan, atrasentan, other specific treatments, or no treatment, along with their caregivers. Each participant will complete a 6-month data collection period involving home-reported outcomes, baseline surveys, monthly check-ins, and an endline survey. After this period, participants may continue tracking symptoms for personal use, with optional data sharing for up to 2 years. During the study, participants report symptoms and treatment details monthly to assess symptom presence, severity, and variability. Researchers will also monitor treatment frequency, reasons for skipping treatment, and quality of life changes. Data collection includes patient-reported outcome scores and flare burden classification. The study involves no interventions and focuses on observation via the mobile app over the initial 6 months and potentially longer for ongoing data integration.

Researchers are evaluating the safety and effectiveness of starting budesonide enteric coated capsules early to treat primary IgA nephropathy, a kidney condition. This prospective, open-label study involves multiple centers and aims to observe changes in proteinuria levels and monitor for any treatment-related abnormal lab values or adverse events over about 12 months. Participants will receive targeted-release budesonide capsules as part of the study. The research includes collecting and testing Gd-IgA1 levels in enrolled subjects. The study is observational, focusing on early initiation of therapy for patients diagnosed within 3 months, with kidney function and protein levels meeting specific criteria. During the study, participants will be regularly assessed for kidney function, protein in urine, microscopic hematuria, and metabolic changes through laboratory tests and urine analysis. Researchers will also track serious kidney outcomes and side effects related to treatment. The total participation period covers about 12 months, including follow-up to evaluate the long-term effects of the therapy.

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 organs 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 in adults with active cutaneous lupus erythematosus CLE, including those who may also have systemic lupus erythematosus SLE. This Phase 2a clinical trial aims to determine if VENT-03 affects the activity and severity of CLE and to assess its safety and how the body processes the drug. Participants will be compared to a placebo group to better understand VENT-03s effects. Participants will take either VENT-03 tablets or a placebo for the first 4 weeks. After this double-blind phase, all participants switch to taking VENT-03 for an additional 8 weeks in an open-label extension. The study uses a randomized, double-blind design with monthly clinic visits for checkups and tests throughout the treatment periods. During the study, participants will visit the clinic once a month for assessments including physical exams and tests to monitor the drugs effects and safety. Researchers will evaluate changes in interferon gene signature in the skin, CLE disease severity, skin biopsy markers, and record any treatment-emergent adverse events. Blood samples will be collected to study the drugs concentration over time. The total treatment duration is 12 weeks with ongoing safety and efficacy monitoring.