Focal Segmental Glomerulosclerosis (FSGS)

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 II/III, 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 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 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 conducting a prospective, multicenter cohort study to follow children with idiopathic nephrotic syndrome (INS), a rare kidney disease. The study aims to collect data on pediatric patients treated by pediatric nephrologists in France and its overseas territories to better understand the disease's characteristics and support future clinical trials. The study involves regularly recording medical, biological, psychological, and social data through routine clinical follow-ups, hospitalizations, and consultations. Additionally, annual telephone interviews will be conducted for patients in remission. Quality of life, treatment adherence, and treatment impact questionnaires will also be collected. A biobank is established to collect blood, urine, hair, and nail samples at the disease onset before immunosuppressive treatment begins. Participants will be followed from disease onset until age 18 or transfer to adult nephrology care. Data is collected via a secure website, medically validated and entered by clinical research staff. The main outcome is the number of cases included and their characteristics over two years. Participation involves routine care visits, interviews, and questionnaires, with continued monitoring planned through the study period ending in 2048.

This research aims to evaluate the use of transcutaneous auricular vagus nerve stimulation (taVNS) as a new treatment option for children aged 3 to 17 years with steroid resistant nephrotic syndrome (SRNS). Children with SRNS often face long-term use of immunosuppressant medications that can have side effects and uncertain benefits. The study focuses on the safety, feasibility, and potential effects of taVNS on immune-related inflammation in this condition. Participants will be randomly assigned to receive either active taVNS or a sham version of the device that looks identical but does not deliver electrical stimulation. Each child will use the device for 5 minutes daily over 26 weeks. The taVNS device sends gentle electrical pulses to the ear's vagus nerve branch. The study includes a screening period, a 26-week randomized treatment phase with monthly in-person and virtual visits, and a 26-week follow-up period to monitor clinical outcomes. After the randomized phase, participants can choose to continue active taVNS in an open-label extension. During the study, children will log heart rate and urine protein levels daily and attend regular visits for physical exams, blood and urine tests, and adherence checks. Researchers will assess kidney function, protein in urine, quality of life, inflammatory markers, and treatment tolerability. Safety and side effects will be monitored throughout. The overall participation lasts up to about 60 weeks, including screening, treatment, and follow-up periods.

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 studying children aged 6 to 18 with frequently relapsing or steroid-dependent nephrotic syndrome to evaluate the safety, how the body processes, and the early effects of SG301, an anti-CD38 monoclonal antibody given by subcutaneous injection. This phase 2, open-label study aims to provide important information about SG301's impact on this condition, which requires ongoing steroid treatment. Participants are divided into two age groups: 12 to under 18 years old and 6 to under 12 years old. The treatment involves nine doses of SG301 injected under the skin: weekly for six weeks, then every two weeks for three doses. Before starting SG301, children receive prednisone to induce remission, with steroid doses gradually reduced over three months. The study includes screening, a 12-week treatment period, and a 40-week follow-up. Throughout the trial, children will be closely monitored with blood tests, urine protein measurements, and evaluations of kidney function. Researchers will track safety by recording treatment-emergent adverse events and measure outcomes like relapse-free survival and relapse frequency over about one year. Additional tests include measuring drug levels, antibodies against SG301, and steroid use. This involvement will last over a year, including treatment and follow-up phases.

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.