Saratoga County

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 effects of a medicine called BI 764198 in adults and adolescents who have a kidney condition known as focal segmental glomerulosclerosis FSGS. This Phase 3 clinical trial aims to determine whether BI 764198 helps improve kidney function in people with primary FSGS or genetic FSGS linked to TRPC6 gene variants. The study is randomized and placebo-controlled, meaning participants are randomly assigned to receive either the medicine or a placebo, and neither the participants nor the researchers know which treatment each person receives. Participants take either BI 764198 tablets or placebo tablets once a day for up to two years, while continuing their usual medication for FSGS. The study involves two groups running in parallel. The main treatment period lasts 104 weeks about two years, during which the participants regularly visit the study site approximately every three months. Both groups are compared to see if BI 764198 affects kidney protein levels and function. During the study, participants provide urine samples regularly to assess their kidney health. Researchers measure changes in urine protein-creatinine ratio and kidney filtration rate from the start to the end of the treatment period. Questionnaires about health-related quality of life are also completed. Doctors monitor participants health and note any side effects throughout the two years. This thorough follow-up helps understand how BI 764198 impacts kidney disease and overall well-being.

This trial focuses on adults with primary IgA nephropathy IgAN who have already completed 9 months of treatment with TARPEYO4 delayed-release budesonide capsules at 16 mg once daily in regular clinical practice. The study aims to determine if continuing TARPEYO4 treatment provides further benefits in reducing proteinuria and protecting kidney function over a longer period. This is a phase 4, open-label study sponsored by Calliditas Therapeutics AB. Participants will undergo an extended treatment regimen lasting about 15 months, starting with 6 months of TARPEYO4 16 mg once daily, followed by 9 months of TARPEYO4 8 mg once daily. After this, there will be a 3-month follow-up period, including a 2-week tapering phase with TARPEYO4 4 mg once daily. The goal is to maintain or improve treatment effects while reducing dosage gradually. During the study, participants will have urine tests, blood samples, and physical exams at regular intervals to monitor kidney function and protein levels. Researchers will measure the urine protein to creatinine ratio UPCR and estimated glomerular filtration rate eGFR at various points, assessing safety by tracking adverse events over approximately 19 months. The study includes thorough follow-up to evaluate the ongoing impact of extended TARPEYO4 use.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

This research evaluates the long-term safety and tolerability of zigakibart in adults with immunoglobulin A nephropathy IgAN. It is an open-label extension study for patients who have completed previous zigakibart trials. The study aims to determine whether zigakibart can be safely used over extended periods in people with this kidney condition. Participants will receive zigakibart as a subcutaneous injection at a dose of 600 mg every two weeks. This extension study follows earlier phase 12 and phase 3 trials and includes patients from these studies. The treatment period is designed to assess continued safety and effects over time during this open-label phase. During the study, participants will have regular assessments including monitoring for adverse events, laboratory tests measuring kidney function, immunoglobulin levels, and drug concentrations. Researchers will track safety lab results, vital signs, and antibody development. The study includes follow-up visits up to several years to evaluate long-term safety and kidney health outcomes such as proteinuria and estimated glomerular filtration rate eGFR.

Researchers are evaluating whether a medicine called BI 764198 helps adults and adolescents with certain kidney conditions, including secondary focal segmental glomerulosclerosis, treatment-resistant primary minimal change disease, Alport Syndrome, and treatment-resistant primary membranous nephropathy. The study is a Phase II, randomized, double-blind, placebo-controlled trial designed to assess the safety, tolerability, pharmacokinetics, and efficacy of BI 764198 in these proteinuric kidney diseases. Participants are randomly assigned to one of two groups, with twice the chance of receiving BI 764198 compared to placebo. They take one tablet daily for 20 weeks while continuing their standard kidney disease medications. The study lasts about seven months, during which participants attend six in-person visits and have three phone calls. The trial includes multiple cohorts based on specific kidney conditions. During the study, doctors regularly collect urine samples to measure protein levels and blood samples to monitor kidney function. Researchers compare these results between the treatment and placebo groups to evaluate changes in proteinuria and kidney filtration rate. Participants health and any side effects are closely monitored throughout the trial.

Researchers are evaluating the effects of balcinrenone combined with dapagliflozin compared to dapagliflozin alone in patients who have chronic heart failure, impaired kidney function, and have recently experienced a heart failure event. This Phase III study is conducted internationally across about 700 sites and aims to assess how these treatments impact cardiovascular death and heart failure events. Participants will be randomly assigned to one of three groups balcinrenonedapagliflozin 15 mg10 mg plus placebo, balcinrenonedapagliflozin 40 mg10 mg plus placebo, or dapagliflozin 10 mg plus placebo. Each participant will take one capsule and one tablet daily. The study duration averages 22 months, including screening, about 20 months of blinded treatment, and a one-month follow-up with open-label dapagliflozin. During the study, participants will undergo assessments for heart failure events, hospitalizations, and cardiovascular death. Researchers will monitor these outcomes over about 38 months, including symptom scores and other health measures. Safety and treatment effects will be followed during the treatment and the one-month post-treatment period.

Researchers are evaluating a new medicine called PF-08634404 combined with chemotherapy for adults with colorectal cancer that has spread to other parts of the body. The study aims to understand how well this new combination works compared to an existing treatment using Bevacizumab with chemotherapy. The study is a phase 3, double-blind, randomized trial focusing on treatment effectiveness and safety in participants who have not received prior systemic therapy for metastatic disease. Participants are randomly assigned to one of two groups. One group receives PF-08634404 with chemotherapy, and the other group receives Bevacizumab with chemotherapy. Both treatments are given through intravenous IV infusions in cycles. Treatment continues as long as it helps and side effects are manageable. Treatments are administered at clinical sites by trained staff. Participants will have regular visits for treatment, health evaluations, and various tests. After stopping treatment, there is a follow-up visit about 30 to 37 days later to review health and side effects. Further follow-up occurs every 12 weeks by phone, in person, or via health record review to monitor health status and any new treatments. The study duration for each participant is approximately 33 months. Researchers will measure progression-free survival, overall survival, response rates, quality of life, and monitor safety throughout the study.

Researchers are evaluating a new medicine called PF-08634404 for adults with locally advanced or metastatic urothelial cancer, a type of bladder cancer that has spread to nearby tissues or other parts of the body. The study aims to assess the safety, effectiveness, how the medicine moves through the body, and its impact on cancer-related markers. This is a Phase 1B2 treatment study sponsored by Pfizer. Participants are divided into two groups Cohort A includes those who have already received treatment and will receive PF-08634404 alone, while Cohort B includes untreated participants who will receive PF-08634404 combined with another cancer medicine called enfortumab vedotin. Both study medicines are given through an intravenous infusion. Treatment continues as long as it is beneficial and side effects are manageable. Before starting treatment, participants undergo a screening period to confirm eligibility. During the study, they have regular visits for treatment, health assessments, and tests to monitor cancer response, including scans. If the cancer worsens but treatment still helps and side effects are manageable, participants may continue treatment with approval. The study tracks outcomes such as tumor response, adverse events, survival, and drug levels over up to three years.

Researchers are evaluating a new medicine called PF-08634404 in adults with advanced Renal Cell Carcinoma RCC, a type of kidney cancer that has spread locally or to other parts of the body. This study aims to understand how the medicine works alone or combined with other anticancer treatments, focusing on safety and cancer response. Participants must be adults with advanced RCC who have not yet received treatment for their advanced kidney cancer. Participants will receive PF-08634404 through intravenous infusions either alone or combined with other anticancer medicines such as ipilimumab or axitinib. The study includes different groups receiving these treatments sequentially, with all infusions delivered at clinical sites by medical staff. Treatment and evaluation will continue for up to approximately three years. During the trial, participants will have regular assessments including scans and lab tests to monitor cancer response and safety. Researchers will measure outcomes such as the confirmed objective response rate, adverse events, dose-limiting toxicities, and survival. Pharmacokinetics and immune responses to the study drug will also be tracked. Participants may be followed for up to three years to evaluate treatment effects and safety.