Saratoga County

Researchers are studying the safety and tolerability of budoprutug, a humanized monoclonal antibody that targets CD19 cells, in adults with primary membranous nephropathy (PMN). This Phase 2, open-label, multicenter trial focuses on patients who are anti-PLA2R antibody positive and continue to have proteinuria despite optimized RAAS inhibition. The study aims to evaluate three different intravenous dose regimens of budoprutug and their effects on this specific kidney condition. Participants will receive budoprutug through single intravenous doses on Day 1, Day 15, Day 169, and Day 183 within one of three sequential dose groups. Approximately 45 subjects will be enrolled, each receiving treatment according to their assigned dosing schedule. The study includes a follow-up period through Week 48, with additional monitoring for B-cell recovery as needed. During the study, participants will undergo safety assessments including monitoring for treatment-emergent adverse events up to 48 weeks. Researchers will also evaluate pharmacodynamics and preliminary efficacy through laboratory tests and clinical evaluations. Regular visits will include tests for kidney function, protein levels in urine, and blood cell counts, alongside other health assessments to ensure participant safety and gather data on how the drug affects the disease.

Researchers are evaluating the effects of a medicine called BI 764198 in adults and adolescents aged 12 years and older who have a kidney condition known as focal segmental glomerulosclerosis (FSGS). This Phase 3 study aims to understand whether BI 764198 can improve kidney health in people with primary FSGS or genetic FSGS related to TRPC6 gene variants by comparing changes in urine protein levels over 104 weeks. Participants are randomly assigned to one of two groups: one group takes BI 764198 tablets once daily, and the other group takes placebo tablets that look like the medicine but contain no active drug. All participants continue their usual FSGS treatments during the study, which lasts up to two years. During the study, participants visit the study site approximately every three months. They regularly provide urine samples to monitor kidney function, and doctors check their overall health and note any side effects. The main outcome measured is the change in the 24-hour urine protein-to-creatinine ratio from the start of the study to week 104, helping researchers understand the treatment's impact on kidney disease.

Researchers are evaluating the extended use of TARPEYO4 (delayed-release budesonide capsules) in adults with primary IgA nephropathy who have already completed 9 months of treatment with TARPEYO4 16 mg once daily in real-world clinical practice. The study aims to determine if continuing TARPEYO4 16 mg once daily for an extended period provides additional treatment benefits, including reducing proteinuria and protecting kidney function. This is a Phase 4 clinical trial focused on assessing both the efficacy and safety of this extended treatment. The study treatment includes a 6-month period of TARPEYO4 16 mg once daily, followed by a 9-month period of TARPEYO4 8 mg once daily. After these treatment periods, participants enter a 3-month follow-up phase that includes a 2-week tapering period with TARPEYO4 4 mg once daily. The goal of this extended regimen is to maintain and improve treatment effects over a total of 2 years of TARPEYO4 therapy. Participants will be involved in the study for about 19 months. During this time, they will undergo urine tests, blood sample collections, and physical examinations to monitor their health and treatment effects. Researchers will measure the ratio of urine protein to creatinine at 6 months compared to baseline to evaluate treatment impact. Safety and kidney function will be closely observed throughout the study and follow-up periods.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating the long-term safety and tolerability of zigakibart, a drug given by subcutaneous injection, in adults with primary immunoglobulin A nephropathy (IgAN). This open-label extension study includes patients who have already completed earlier zigakibart studies, aiming to gather more information about the drug's safety during extended use. The study is multicenter and non-randomized, following previous Phase 1/2 and Phase 3 clinical trials. Participants receive zigakibart 600 mg by subcutaneous injection every two weeks during the extension period. The study continues the treatment from the parent trials and monitors patients under open-label conditions. This allows researchers to observe the long-term effects of zigakibart in a real-world setting for those with IgAN. Throughout the study, researchers monitor participants for adverse events, serious adverse events, and specific adverse events of special interest from the start of treatment until 24 weeks after the last dose. Participants will be regularly assessed for safety and tolerability, with careful follow-up to understand the drug’s impact over time. The trial includes adults aged 18 to 100 years who meet specific health requirements and who have completed a prior zigakibart study.

Researchers are evaluating whether the medicine BI 764198 can help adults and adolescents with specific kidney diseases, including secondary focal segmental glomerulosclerosis, treatment-resistant primary minimal change disease, Alport Syndrome, and treatment-resistant primary membranous nephropathy. This Phase II study aims to assess the safety, tolerability, and effectiveness of BI 764198 compared to a placebo in these proteinuric kidney diseases. Participants are randomly assigned to one of two groups: one group takes BI 764198 tablets once daily, while the other takes placebo tablets that look like the medicine but contain no active drug. All participants continue their usual kidney disease treatments during the 20-week treatment period. After treatment, there is a follow-up period, and overall, participants are involved in the study for about seven months. During the study, participants visit the study site six times and have three phone calls with the study team. Doctors regularly collect urine and blood samples to monitor protein levels and kidney function. Researchers compare these results between the two groups to determine if BI 764198 affects kidney disease markers. Participants' health and any side effects are also closely monitored throughout the study.

Researchers are evaluating the efficacy, safety, and tolerability of subcutaneous ianalumab given every 4 weeks or every 12 weeks compared to placebo, all combined with standard-of-care therapy, in adults with active lupus nephritis. This phase 3 trial focuses on participants with specific classes of lupus nephritis confirmed by recent kidney biopsy and meeting established diagnostic criteria. Participants will receive either ianalumab every 4 weeks, ianalumab every 12 weeks, or a placebo, all given by subcutaneous injection alongside standard lupus nephritis treatment. Standard-of-care includes induction therapy with high-dose corticosteroids and mycophenolic acid (MPA). Treatment schedules and doses are carefully monitored throughout the study. Participants will be involved in regular assessments including kidney function tests, urine protein measurements, and clinical evaluations up to week 72 to monitor treatment response and safety. The primary outcome is the frequency of participants achieving stable complete renal response by week 72. Safety and tolerability are also closely tracked during the trial period.

Researchers are evaluating the effect of balcinrenone/dapagliflozin compared with dapagliflozin alone on cardiovascular death and heart failure events in patients with chronic heart failure and impaired kidney function who recently experienced a heart failure event. This is a Phase III, international, randomized, double-blind, parallel-group, active-controlled study involving approximately 700 sites in about 40 countries. Participants will be randomly assigned in a 1:1:1 ratio to receive one of three treatments once daily: a capsule of balcinrenone/dapagliflozin 15 mg/10 mg with a placebo tablet, a capsule of balcinrenone/dapagliflozin 40 mg/10 mg with a placebo tablet, or a dapagliflozin 10 mg tablet with a placebo capsule. The study is event-driven, with an estimated average duration of 22 months that includes a screening period, a 20-month blinded treatment phase, and a one-month follow-up on open-label dapagliflozin. During the study, participants will be monitored for the time to first occurrence of cardiovascular death, heart failure hospitalization, or heart failure events without hospitalization over approximately 38 months. Assessments include clinical evaluations, laboratory tests, and safety monitoring throughout the study and follow-up period to track treatment effects and patient outcomes.

Researchers are studying a new medicine called PF-08634404 to learn more about its safety, how it works, and how it affects 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 also examines how the medicine may change certain markers linked to cancer. This research is an interventional Phase 1B/2 trial including participants who have this specific cancer type. The study includes two groups: Cohort A consists of people who have already received treatment for their cancer and will receive PF-08634404 alone. Cohort B includes participants who have not been treated before and will receive PF-08634404 combined with another cancer medicine called enfortumab vedotin. Both treatments are given through a vein (IV infusion). Treatment continues as long as it is helpful and side effects are manageable. Participants will first go through a screening period to confirm eligibility. During the study, they will have regular visits for treatment, health checks, and tests to monitor how the cancer responds, including regular scans. Researchers will measure how well the treatment works by confirmed objective response rate and will monitor safety by tracking adverse events, serious adverse events, and dose-limiting toxicities for up to about three years. If the cancer worsens but treatment still helps and side effects remain manageable, participants may continue treatment with approval from their doctor and the study sponsor.

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 phase 1b/2 study aims to assess the safety and how well PF-08634404 works alone or combined with other anticancer medicines in treating this advanced kidney cancer. Participants must be adults who have not yet received treatment for their advanced RCC. Participants will receive PF-08634404 either by itself or together with other anticancer drugs through intravenous (IV) infusions administered at clinical study sites by trained medical staff. The study includes treatment periods where the medicine is given as a concentrate solution for infusion, with combinations involving two other anticancer drugs also evaluated. All treatments occur under close medical supervision at the study centers. During the study, participants will have regular assessments including measuring tumor response using RECIST v1.1 criteria for up to approximately three years. Researchers will monitor safety by tracking treatment-emergent and serious adverse events, as well as dose-limiting toxicities during the evaluation period. Participants' health will be closely followed through clinical and laboratory tests throughout the study to understand the medicine's effects and safety profile.