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 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 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 evaluating budoprutug, a humanized monoclonal antibody targeting CD19, in adults with primary membranous nephropathy (PMN) who have anti-PLA2R antibodies and persistent proteinuria despite optimized RAAS inhibitor treatment. This Phase 2, open-label study aims to assess the safety, pharmacodynamics, and preliminary efficacy of this investigational drug in this patient group. Participants will receive one of three sequential intravenous dose regimens of budoprutug. Each participant will receive single IV doses on Days 1, 15, 169, and 183. Approximately 45 subjects will be enrolled across three different dose cohorts. Following treatment, participants will be monitored through Week 48, with extended follow-up for B-cell recovery as needed. Throughout the study, researchers will track safety by recording treatment-emergent adverse events up to Week 48. They will also evaluate changes in total B cell count, anti-PLA2R antibodies, proteinuria, kidney function measures (eGFR, UACR), and remission rates. Participants will have regular assessments including laboratory tests and clinical evaluations to monitor these outcomes and ensure safety.

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 B007—350mg, 700mg, or 1000mg—or 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. James's 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 evaluating how much Eloralintide (LY3841136) reaches the bloodstream and how quickly it is cleared in people with kidney impairment compared to those with normal kidney function. This study focuses on participants with severe renal impairment, end-stage kidney disease on stable hemodialysis, and healthy individuals with normal renal function. The study aims to understand the pharmacokinetics and safety of the drug when given by injection under the skin. Participants receive a single dose of Eloralintide administered subcutaneously. The study includes three groups: one group with normal kidney function, one with impaired kidney function, and one with end-stage renal disease undergoing hemodialysis. The study design is open-label and non-randomized, lasting about 14 weeks for each participant, excluding the screening period. During the study, participants will undergo assessments to measure the drug concentration in their blood over time, including the area under the concentration curve and the maximum drug concentration. Researchers will monitor safety and collect medical history, physical exams, and other screening tests. The study is sponsored by Eli Lilly and Company and aims to provide detailed information about how Eloralintide behaves in the body of those with varying kidney functions.

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.

Immunoglobulin A nephropathy (IgAN) is a kidney disease caused by immune system proteins building up in the kidneys, leading to inflammation and potential kidney damage. This trial aims to evaluate how mezagitamab affects protein levels in the urine compared to a placebo in adults with primary IgAN. The study also looks at the safety and tolerability of mezagitamab, along with its ability to maintain kidney function over time. Participants will be assigned randomly to one of two groups in the main part of the study: one receiving mezagitamab injections and the other receiving placebo injections, both given under the skin. Treatment lasts about 22 weeks within each 52-week cycle, with two such cycles planned. There is also an open-label group for certain participants who have lower protein levels or reduced kidney filtering ability; they will receive mezagitamab treatment similar to the main group. Participants will have monthly check-ups and be closely monitored throughout. During the study, participants will visit the clinic multiple times for assessments including urine protein measurements, kidney function tests, and safety monitoring. The main outcome is the change in urine protein at week 36, with additional measures of kidney filtering rate and kidney failure risk tracked up to week 104. The study duration and follow-up ensure thorough observation of treatment effects and safety over two years.