San Dimas

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating the safety and effects of different doses of a new medicine called NNC0519-0130 in people living with chronic kidney disease, some of whom have type 2 diabetes and are overweight or obese. This Phase 2 study also compares NNC0519-0130 to semaglutide, an already prescribed medicine, and a placebo to see how they may improve kidney function. Participants will be randomly assigned to receive once-weekly subcutaneous injections of NNC0519-0130 with a fixed dose escalation until reaching a maintenance dose, semaglutide with a similar dosing schedule, or a placebo matching NNC0519-0130. The treatment period lasts up to 43 weeks with several dosing schemes and groups. During the study, participants will have their kidney function monitored through urine albumin-to-creatinine ratio changes at weeks 12, 24, and 36. Other assessments include estimated glomerular filtration rate, body weight changes, waist circumference, blood pressure, and glycated hemoglobin levels. Safety will be evaluated by tracking adverse events throughout the trial duration. Participants will be regularly assessed to understand the medicines effects and safety.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating AP301, a novel iron-based phosphate binder, in patients with chronic kidney disease who are receiving maintenance dialysis and have elevated blood phosphate levels. This phase 3, randomized, double-blind study aims to determine whether AP301 lowers blood phosphate and how it affects serum calcium, calcium times phosphate, and intact parathyroid hormone levels. The trial also assesses any discomfort or medical problems during treatment and its impact on quality of life in Chinese patients. Participants will first stop all phosphate-lowering medications. They will then take either AP301 or a low-dose comparator considered ineffective three times daily for 8 weeks. Following this, all participants receive AP301 three times daily for 24 weeks, with dose adjustments based on blood phosphate levels and physician judgment. Finally, participants will take either AP301 or the comparator three times daily for 3 weeks. Additional treatments may be given if blood phosphate levels become too high or low. During the study, participants will undergo regular assessments including blood tests to monitor serum phosphate, calcium, and parathyroid hormone levels. Electrocardiogram tests will measure changes in QT intervals. Safety is monitored by tracking adverse events throughout the trial, which lasts up to 37 weeks. The primary outcome is the change in serum phosphate concentration from baseline to the end of week 8, with ongoing evaluations over the entire study period.

Researchers are conducting a Phase 2 randomized, double-blind, placebo-controlled study to evaluate the effects and safety of praliciguat in adults diagnosed with biopsy-confirmed focal segmental glomerulosclerosis FSGS. This kidney condition is being studied to understand how praliciguat impacts protein levels in urine and other health measures compared to placebo. The study is sponsored by Akebia Therapeutics and involves multiple centers. Participants will be randomly assigned to receive either praliciguat or a matching placebo daily during a 24-week double-blind period. The praliciguat dose will be gradually increased to a target level. After this period, all participants will continue with an open-label phase where everyone receives praliciguat daily for another 24 weeks. Throughout the study, participants will have their urine protein-to-creatinine ratio UPCR measured from baseline through Week 24 to assess treatment effects. Additional evaluations include monitoring partial remission rates at Week 24 and measuring plasma praliciguat levels at Weeks 24, 32, and 36. The total participation lasts up to 48 weeks, with safety and efficacy assessments occurring regularly during and after the treatment periods.

Researchers are evaluating the use of SNP-ACTH 1-39 Gel compared to rituximab for treating adults with primary membranous nephropathy PMN, a kidney condition. This trial uses a two-phase adaptive design to find the best dose of SNP-ACTH Gel and then assess its effectiveness against rituximab. The study is divided into Phase 3a for dose finding and Phase 3b for comparing treatments over 24 months. In Phase 3a, up to 24 patients will be randomly assigned to receive either 3 mg or 5 mg of SNP-ACTH Gel by subcutaneous injection three times a week for 12 months. Data from this phase will guide dose selection for Phase 3b. In Phase 3b, 132 patients will be randomized to receive either the selected dose of SNP-ACTH Gel for 12 months or rituximab infusions given in two cycles, one at the start and one at six months. Participants will be monitored throughout the study with regular assessments of urinary protein and auto-antibody levels during Phase 3a, and clinical responses at 24 months in Phase 3b. Researchers will track kidney function, relapse rates, immune responses, and safety outcomes. Study visits and evaluations will occur at multiple time points up to two years, supporting detailed understanding of treatment effects and patient health over time.

Researchers are evaluating the safety and how the body processes AZD7760 in two groups healthy adults and adults with end-stage kidney disease who are on hemodialysis using a central venous catheter. This study includes a Phase I for healthy participants and a Phase IIa for those with kidney disease, to better understand the effects and safety of AZD7760 given intravenously. In Phase I, participants are randomly assigned to receive one of three doses of AZD7760 or a placebo as a single intravenous infusion. The study includes a 28-day screening period, a 3-day dosing period with a single infusion on the first day, and a 12-month follow-up after treatment. In Phase IIa, participants receive two intravenous infusions of either AZD7760 or placebo three months apart, with a similar 28-day screening and a 12-month follow-up after the last dose. Participants will be monitored through the study with assessments including safety evaluations for adverse events and blood tests to measure drug levels and immune responses. Researchers will track side effects, drug concentration peaks, and how long the drug stays in the body. The total involvement can last up to over a year, including screening, dosing, and follow-up periods to ensure thorough safety and pharmacokinetic monitoring.

This research aims to evaluate the safety, tolerability, and effectiveness of the drug AP306 at fixed doses in adults with hyperphosphatemia who are undergoing maintenance hemodialysis. Hyperphosphatemia is a common complication in advanced chronic kidney disease and is linked to increased risks of cardiovascular problems, fractures, and death, especially in patients receiving dialysis. The study is a randomized, double-blind, placebo-controlled Phase 2b trial designed to assess these effects. Participants will receive AP306 orally at various fixed doses or placebo, administered daily for 8 weeks. The drug is given either twice or three times daily depending on the dose group, with doses ranging from 75 mg to 125 mg per administration. The study includes seven cohorts, six receiving different doses of AP306 and one receiving placebo, to compare safety and serum phosphate-lowering effects. Throughout the study, participants will be monitored with regular assessments including blood tests to measure serum phosphate levels and other safety parameters. Researchers will evaluate how well AP306 lowers phosphate levels over the 8-week treatment period. Participants adherence and tolerability to the medication will also be tracked. The trial will continue until March 2027, with data collection focused on treatment response and safety.

Researchers are evaluating the efficacy, safety, and pharmacokinetics of sefaxersen RO7434656, a new Antisense Oligonucleotide ASO therapy, in adults with primary IgA nephropathy IgAN who are at high risk of worsening kidney disease despite receiving optimized supportive care. This phase III study focuses on participants who continue to face disease progression despite standard treatments. Participants will receive subcutaneous injections of either sefaxersen or a matching placebo. The dosing schedule includes injections on Days 1, 15, and 29, followed by doses once every four weeks until Week 105. After Week 105 or the primary data cut-off, eligible participants may switch to open-label sefaxersen treatment at the investigators discretion. Throughout the study, participants will undergo assessments to measure changes in urine protein-to-creatinine ratio at Week 37, kidney function eGFR slope at Week 105, and monitor for hematuria resolution, kidney failure events, fatigue, and treatment-emergent adverse events. Blood samples will be collected to measure plasma sefaxersen levels. The total study duration extends up to approximately 36 months, with ongoing safety and efficacy monitoring.

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.