Cheektowaga

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 investigating treatments for participants with high-grade non-muscle invasive bladder cancer NMIBC that is unresponsive to Bacillus Calmette-Guerin BCG therapy. This phase 3 trial evaluates the safety and effects of nadofaragene firadenovec, a gene therapy, used alone or combined with chemotherapy or immunotherapy. The study aims to build on earlier findings where over half of participants achieved a complete response in a previous trial. Participants will be randomly assigned to receive one of the following nadofaragene firadenovec alone via intravesical instillation, nadofaragene firadenovec combined with intravesical gemcitabine and docetaxel chemotherapy, or nadofaragene firadenovec combined with intravenous pembrolizumab immunotherapy. The pembrolizumab arm is now closed to new participants, focusing enrollment on the other two arms. Treatments will be administered according to the study protocol to assess their effects on bladder cancer. During the trial, participants will undergo regular evaluations including tumor assessments, pathology staging, and monitoring for disease progression and adverse events for up to 36 months. The main outcomes measured include complete response rates at 3 and 6 months, durability of response, progression to muscle-invasive disease, need for cystectomy, and overall survival. Safety and tolerability will also be closely observed. Participants will be followed throughout the study duration, which extends up to the end of 2030.

This research evaluates semen quality after treatment with the Optilume Urethral Drug Coated Balloon DCB in men aged 22 to 65 who have an anterior urethral stricture treatable with this device. It is a single-arm, prospective study involving 34 male participants across multiple sites in the United States. The study aims to assess various urinary and sexual function outcomes following treatment. Participants receive the Optilume Urethral DCB, a catheter with a balloon coated with the drug paclitaxel that transfers the medication to the urethral wall upon inflation. The study includes follow-up visits at 30 days, 3 months, 6 months, and 12 months after treatment to monitor symptoms and function. Semen quality is tested before treatment and at 3 and 6 months post-treatment, with additional testing up to 12 months if abnormalities are detected. During the study, participants undergo evaluations of urinary symptoms, sexual function, and voiding function at scheduled intervals. Semen samples are collected to assess sperm characteristics. Safety endpoints are reviewed at 3 and 6 months. Follow-up continues for up to a year or longer if semen abnormalities persist, ensuring comprehensive monitoring of treatment effects and participant well-being.

This trial evaluates nadofaragene firadenovec, a gene therapy using interferon alfa-2b amplification, compared with observation in participants with intermediate risk non-muscle invasive bladder cancer IR NMIBC. The study is a phase 3b, randomized, controlled trial aiming to assess treatment effects on recurrence-free survival over 24 months. Participants in the treatment group receive quarterly bladder instillations of nadofaragene firadenovec for 24 months. Disease evaluations occur within two weeks before each treatment instillation. Participants in both groups are followed according to the American Urological AssociationSociety of Urologic Oncology surveillance guidelines, which involve quarterly monitoring during the 24-month treatment period. During the study, participants undergo regular disease assessments, including monitoring for cancer recurrence and safety evaluations over 24 months. The main outcome measured is recurrence-free survival at 24 months. Adverse events and recurrence-free survival at 12 months are also tracked. Participants are monitored closely throughout the treatment and observation periods to evaluate long-term effects and safety.