Membranous Nephropathy

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.

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 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 12, 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 33 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 evaluating the safety and tolerability of three different dose regimens of budoprutug in adults with primary membranous nephropathy PMN who test positive for anti-PLA2R antibodies and continue to have proteinuria despite optimized RAAS inhibition. This Phase 2, open-label, multicenter study aims to assess the safety, pharmacodynamics, and early effectiveness of budoprutug, a humanized monoclonal antibody that targets CD19 to deplete specific cells through antibody-dependent cellular cytotoxicity. Participants will receive a single intravenous dose of budoprutug on Days 1, 15, 169, and 183 across three sequential dose groups. Approximately 45 subjects will be enrolled and treated with one of the three dose levels. The study includes an initial dosing period followed by extended follow-up to monitor B-cell recovery and other effects up to Week 48. During the study, participants will be closely monitored for adverse events and changes in various laboratory measures, including B cell counts, anti-PLA2R antibody levels, proteinuria, and kidney function. Researchers will evaluate safety outcomes up to Week 48 and assess pharmacokinetics such as plasma concentration and clearance. Follow-up visits will track participant health, treatment effects, and recovery over the course of the study.

Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary effectiveness of a recombinant humanized anti-CD20 monoclonal antibody given by subcutaneous injection for treating primary membranous nephropathy. This Phase I clinical study aims to better understand how this treatment works and its potential benefits for patients with this kidney condition. Participants are randomly assigned to receive one of three doses of the study drug B007350mg, 700mg, or 1000mgor a matching placebo. Each dose is given by subcutaneous injection on days 1 and 15. The study uses a double-blind design to compare the effects of the active drug versus placebo. Treatment and observation extend over approximately two years to assess safety and clinical outcomes. During the trial, participants undergo regular monitoring for dose-limiting toxicities and treatment-emergent adverse events. Pharmacokinetic and pharmacodynamic profiles, immunogenicity, and relevant biomarkers are measured over about one year. The study also tracks the proportion of subjects achieving clinical remission over two years. Researchers collect safety data and evaluate how the study drug behaves in the body to inform future research and treatment development.

This research focuses on primary membranous nephropathy PMN, a kidney condition, by comparing how well rituximab combined with hormones works versus rituximab alone. The study is designed as a randomized, controlled, multicenter clinical trial, and also includes a real-world observation of patients who do not meet trial criteria or choose not to join the main study, to better understand treatment effects across a wider group. Participants will receive treatment following established clinical protocols, either rituximab with hormones or rituximab alone. Alongside treatment, the study will explore changes in kidney and blood at genetic and molecular levels, including genome-wide, transcriptome, proteome, metabolome, and microbiome shifts. Researchers will also analyze kidney pathology images to predict which patients might respond best to rituximab. During the study, participants will be monitored for treatment response over 24 months, with key measures including complete response rates at 12 months, remission times, recurrence rates, medication doses, immune cell counts, kidney function, and adverse events. This includes regular evaluations of laboratory tests and clinical outcomes to assess treatment safety and effectiveness. The study starts in November 2024 and continues until November 2027.

Researchers are evaluating whether using a digital smartphone application can help adults with chronic kidney disease CKD better follow the 2024 Kidney Disease Improving Global Outcomes KDIGO guidelines. The study focuses especially on young adults transitioning from pediatric to adult nephrology care, who face higher risks and challenges during this vulnerable period. The research aims to improve treatment adherence and health outcomes by addressing gaps in current care and guideline implementation. Participants will use a modified version of the St. Jamess Hospital Renal App, which has been adapted to align with the KDIGO 2024 guidelines. The app provides tailored recommendations, reminders, educational materials, and collects patient-reported outcomes. The study uses a randomized stepped wedge design where patients receive first exposure and later continued use of the app. The intervention supports healthcare providers by highlighting opportunities for evidence-based therapies and helps patients manage their care digitally. During the study, participants will be monitored for changes in adherence to KDIGO guidelines over 18 months. Assessments will include patient engagement, clinical data integration via electronic health records, and patient-reported measures. The app also supports appointment management and medication reminders, aiming to enhance self-management and slow CKD progression. The research includes diverse patient subgroups and considers cultural and linguistic needs to promote equitable care.

Researchers are studying Eloralintide LY3841136 to understand how much of the drug reaches the bloodstream and how long the body takes to clear it in people with kidney problems compared to those with normal kidney function. The study focuses on participants with different levels of kidney impairment, including those with severe renal impairment and those with end-stage renal disease on stable hemodialysis. This is a Phase 1 trial to evaluate the pharmacokinetics and safety of a single dose of Eloralintide. Participants will receive one subcutaneous under the skin injection of Eloralintide. The study includes groups with normal kidney function, severe renal impairment, and end-stage renal disease on hemodialysis. The study drug is administered once, and participants with end-stage renal disease will be on a stable hemodialysis schedule for at least three months before dosing. The study is open-label and non-randomized with parallel groups. Each participants involvement lasts about 14 weeks, not including the initial screening period. During this time, researchers will collect blood samples to measure drug levels and how it is processed by the body. Safety and pharmacokinetics are monitored through these assessments. The primary outcomes include the total drug exposure over time and the highest drug concentration observed. Participants may undergo physical exams, medical history reviews, and laboratory tests as part of the study assessments.

Researchers are evaluating the safety of maribavir in adults who have severe chronic kidney disease CKD or end-stage renal disease ESRD, including those on dialysis, and who have a refractory cytomegalovirus CMV infection after transplantation. This observational study collects already existing data from participants medical records without changing their standard medical care or treatment. The study includes adults aged 18 years or older who have undergone solid organ or stem cell transplantation and have been treated with maribavir for refractory CMV infection. Data will be collected from the start of maribavir treatment through up to seven days after the last dose or until death or end of available data, whichever comes first. Participants include those with severe CKD or ESRD, including those on peritoneal or hemodialysis. Participants medical records will be reviewed to monitor any adverse events from maribavir treatment during the study period, which can last up to four years. The main measurement is the number of participants experiencing adverse events, including those of special interest. This review will not affect participants usual care, and no new treatments or interventions will be given as part of this study.

This research aims to evaluate mezagitamab for adults with primary Immunoglobulin A nephropathy IgAN, a kidney disease caused by immune protein buildup leading to inflammation and potential kidney damage. The study will compare how mezagitamab affects protein levels in urine proteinuria against a placebo, focusing on safety, tolerability, and maintenance of kidney function over time. Participants will be randomly assigned to either receive mezagitamab or a placebo injection subcutaneously over approximately 22 weeks in the main group, with a 21 ratio favoring mezagitamab. An open-label group includes participants with specific proteinuria or kidney filtration levels, including those from a prior related study, all receiving mezagitamab in the same manner. After treatment, participants will be observed for about 1.5 years with regular check-ups. During the study, participants will attend multiple clinic visits for treatment and monitoring. Researchers will measure changes in proteinuria at Week 36 as the primary outcome, as well as kidney filtration rates over one and two years. Safety and long-term kidney function will be closely monitored throughout the 2-year participation period.