Nephrotic Syndrome

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 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 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.

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.

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, and effect on albuminuria of the drug MZE829 in adults with proteinuric chronic kidney disease who carry the APOL1 high risk genotype. This open-label Phase 2 study focuses on participants with proteinuria and the specific genetic risk factors G1/G1, G2/G2, or G1/G2. The study aims to better understand how MZE829 impacts kidney disease in this targeted group. Participants will receive MZE829 capsules taken orally. The study includes two groups: one with chronic kidney disease and concurrent diabetes, and another with chronic kidney disease without diabetes. The treatment period lasts 12 weeks, during which safety and tolerability will be closely monitored along with the drug's effect on albuminuria. This design allows researchers to assess the drug’s impact across different patient profiles. During the study, participants will be monitored from Day 1 through Week 12 with regular assessments for adverse events and measurement of albuminuria reduction. Researchers will also track plasma drug concentrations to understand how the body processes MZE829. Safety and tolerability will be evaluated based on the incidence of any adverse events throughout the 12-week treatment period. The total duration involves close observation and follow-up during this timeframe to evaluate the study outcomes.

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 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.