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 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 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 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 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 diseases 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 ears 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. 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 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 SG301s 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 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.