Kasugai

Researchers are investigating the long-term safety and tolerability of open-label iptacopan in adults with primary IgA nephropathy who have previously completed specific clinical trials (CLNP023X2203 or CLNP023A2301). This extension study is designed to allow participants continued access to iptacopan until certain conditions are met, such as reaching three years from the last patient first visit, loss of treatment benefit, negative benefit-risk profile, initiation of dialysis or kidney transplant, or commercial availability of the drug. The study will also assess the drug's effects on disease progression every six months. Participants who completed the prior trials and meet inclusion criteria may receive oral iptacopan capsules at a dose of 200 mg twice daily. The study is open-label and non-randomized and will continue treatment under this regimen until one of the study-defined stopping points is reached. Supportive care with ACE inhibitors or ARBs is maintained as per clinical guidelines, and vaccination against certain infections is required before enrollment. During the study, participants will be monitored for safety, including serious adverse events, adverse events of special interest, vital sign abnormalities, ECG changes, and laboratory test abnormalities from the first day of treatment until seven days after the last dose. Efficacy assessments occur every six months to evaluate clinical effects on disease progression. The study aims to collect long-term safety and tolerability data while providing ongoing treatment access until the drug becomes commercially available or other stopping criteria apply.

Researchers are studying the effects of DMX-200 (repagermanium), a drug that blocks a receptor involved in inflammation, in people with focal segmental glomerulosclerosis (FSGS) who are also taking an angiotensin II receptor blocker (ARB). This Phase 3 trial aims to assess the safety and effectiveness of DMX-200 compared to placebo over 104 weeks in adults and adolescents aged 12 to 17 years. Following the initial study, an open-label extension will evaluate long-term safety and benefits for up to two more years. Participants will be randomly assigned to receive either DMX-200 at 120 mg twice daily or a placebo, while continuing their ARB treatment. The study includes a screening and qualification period lasting 6 to 14 weeks, a 104-week double-blind treatment phase, and a 4-week follow-up after treatment. Those completing this phase may enter the open-label extension for an additional minimum of 104 weeks, with another 4-week follow-up period, making the total study duration about 230 weeks. During the trial, participants will undergo regular assessments including urine protein and creatinine testing, kidney function monitoring by estimated glomerular filtration rate (eGFR), and safety evaluations. The main outcomes measured are changes in proteinuria, kidney function slope up to week 104, and long-term safety through week 216. Safety will be closely monitored throughout both the double-blind and extension periods to understand the drug's effects over time.

The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible participants will be randomly assigned (by chance) to receive ibuzatrelvir or matching placebo orally for 5 days. Co-administration of locally available standard of care is allowed. The total duration of the study is around 6 months.

This research aims to evaluate the safety and effects of the study medicine PF-07328948 for adults with heart failure. It focuses on how this medicine works compared to a placebo in people who are already using standard heart failure treatments that include sodium-glucose cotransporter 2 (SGLT2) inhibitors. The trial is a Phase 2 study designed to better understand if PF-07328948 is safe and effective for managing heart failure symptoms and improving patients' health. Participants will be randomly assigned to receive either placebo tablets or one of three doses of PF-07328948 (low, medium, or high dose). All medications are taken once daily by mouth for 36 weeks. The treatment period is followed by ongoing study visits to monitor participants. The study involves 15 visits over about 48 weeks, with 10 visits at the study site and 5 visits conducted remotely by phone. During the study, researchers will assess participants at the start and after 36 weeks by measuring clinical events, changes in the six-minute walk test distance, and changes in heart failure symptoms using the Kansas City Cardiomyopathy Questionnaire. Safety and treatment effects will be closely monitored through these visits and assessments throughout the study period.

Researchers are evaluating the safety and effectiveness of rituximab (genetical recombination) given through an intravenous infusion for people with idiopathic membranous nephropathy who also have nephrotic syndrome. This phase 3 study aims to confirm how well rituximab works and how safe it is compared to a placebo. The study focuses on patients aged 15 years and older who meet specific clinical criteria related to their kidney condition and protein levels. Participants will receive either rituximab or a placebo through intravenous infusions given every two weeks for two doses during the double-blind phase. If patients do not show sufficient improvement by week 26, they may enter an open-label phase where they can receive rituximab again if deemed necessary by the investigator. The treatment dosing in the open-label phase is the same as in the initial phase, with two doses of 1,000 mg rituximab given every two weeks. During the study, participants will be monitored to measure the percentage of patients achieving predefined remission criteria by week 26. Assessments will likely include lab tests for protein levels and albumin in the blood, kidney function, and safety evaluations. The study involves informed consent, screening for eligibility, and ongoing monitoring to evaluate treatment response and safety throughout the study period.

Researchers are evaluating the efficacy, safety, and tolerability of povetacicept in adults with primary membranous nephropathy (pMN), a kidney condition confirmed by biopsy. This study is a Phase 2b/3 adaptive, randomized, active-controlled trial comparing povetacicept with a calcineurin inhibitor treatment. Participants will receive either povetacicept, given as a solution for subcutaneous injection, or tacrolimus capsules taken orally. The study aims to compare these treatments in managing pMN over the course of the trial. Throughout the study, researchers will monitor participants for the proportion who achieve complete clinical remission by Week 104. Safety, tolerability, and other clinical outcomes will also be assessed to understand the treatments' effects over time.