Nadiad

Researchers are evaluating the effects of felzartamab in adults with Immunoglobulin A nephropathy (IgAN), a kidney disease caused by the buildup of abnormal IgA antibodies in the kidneys. This buildup leads to inflammation and damage, causing protein to appear in the urine. The study aims to understand how felzartamab influences proteinuria and kidney function, while also assessing the safety and how the body processes this treatment. This is a Phase 3, randomized, double-blind, placebo-controlled study focusing on adults with IgAN. Participants will be randomly assigned to receive either felzartamab or a placebo through intravenous (IV) infusions. Neither the participants nor the researchers will know which treatment is given. The treatment period lasts 24 weeks followed by an 80-week follow-up period. In total, participants will attend 17 study visits over about 2 years to receive infusions and participate in study activities. During the study, participants will undergo assessments including urine tests to measure protein levels, kidney function evaluations, and safety monitoring. Researchers will track changes in proteinuria from the start of the study to Week 36 as the main outcome. Additional measurements will include kidney function, clinical endpoints, and the study of how felzartamab is processed by the body. Participant safety and long-term effects will be monitored throughout the study and follow-up periods.

Researchers are evaluating the safety of darolutamide combined with standard androgen deprivation therapy (ADT) in Indian men who have high-risk non-metastatic castration-resistant prostate cancer (nmCRPC). This type of prostate cancer does not spread to other parts of the body but progresses despite very low levels of male hormones called androgens. The study focuses on men whose prostate-specific antigen (PSA) levels rise quickly, indicating potential tumor growth. Darolutamide works by blocking androgens from attaching to cancer cell proteins, and this study aims to learn about its safety in Indian participants, comparing results to a previous study that did not include Indian patients. All participants will take darolutamide tablets orally twice daily, with a total daily dose of 1200 mg. They will continue standard ADT, which lowers androgen levels. Participants will visit the study center every 16 weeks until their cancer worsens, medical issues develop, they leave the study, or the study ends. If the trial stops, participants may continue darolutamide if it benefits them. During the study, researchers will collect blood and urine samples, perform physical exams, check vital signs, assess heart health with ECG, and evaluate daily living abilities using ECOG performance status. They will monitor medical problems called adverse events (AEs), including lab test results, physical findings, heart function, vital signs, and changes in daily living abilities over about 15 months. These safety and effectiveness results will help understand how darolutamide works in real-world conditions for this group.

Researchers are investigating the effects of a medicine called BI 690517 in combination with empagliflozin for adults with chronic kidney disease who are at risk of their condition worsening. This study includes people both with and without type 2 diabetes and those already taking certain kidney-related medicines like ACE inhibitors or angiotensin receptor blockers. The goal is to understand if adding BI 690517 helps protect kidney function and reduces risks related to kidney failure and heart problems. This is a Phase 3 clinical trial conducted over about 3 to 4 years. The study has two parts. First, participants receive either empagliflozin or a placebo similar to BI 690517 for at least six weeks, while continuing other indicated treatments like ACE inhibitors or ARBs. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the rest of the study. The placebo tablets look like BI 690517 but contain no active medicine. Participants have regular visits to the study site, about four times in the first six months, then every six months afterward. During these visits, doctors monitor kidney function, heart health, blood pressure, weight, and any side effects. Blood and urine samples are taken to track health changes. The main outcomes measured are the time until worsening kidney disease, hospitalization for heart failure, or cardiovascular death. The study ends when a certain number of these events have occurred.

Researchers are evaluating the safety, effectiveness, behavior in the body, and biological effects of WAL0921 in adults with certain glomerular kidney diseases that cause proteinuria. These diseases include diabetic nephropathy, primary focal segmental glomerulosclerosis, treatment-resistant minimal change disease, primary immunoglobulin A nephropathy, and primary membranous nephropathy. This study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled trial designed to better understand how WAL0921 works and its safety profile in these patients. Participants will be randomly assigned to receive either WAL0921 or a placebo through an intravenous infusion every two weeks for a total of seven infusions. After the treatment period, all participants will be monitored for an additional 24 weeks to observe any long-term effects. The study setup allows comparison between the investigational drug and placebo to assess treatment impact. During the study, participants will be closely monitored for any treatment-related side effects from the start of the study through week 36. Regular assessments will include safety checks and evaluations to track how the drug affects their condition. This monitoring aims to ensure participant safety and to measure important outcomes related to kidney health and proteinuria over the entire study period.

Chronic kidney disease (CKD) is a major global health concern, ranking as the 12th leading cause of death with a rising prevalence, especially in South Asia where one in seven adults is affected. Among kidney diseases, IgA nephropathy (IgAN) is the most common primary glomerular disease in adults and leads to severe kidney damage over time. South Asian patients with IgAN tend to experience faster disease progression and worse outcomes compared to other populations. This trial aims to evaluate whether adding commonly available generic drugs to standard care can improve kidney function decline in adults with biopsy-confirmed primary IgAN in South Asia. Participants will be randomly assigned to receive one of several treatments alongside standard care, which includes the maximum tolerated dose of ACE inhibitors or angiotensin receptor blockers and a steady dose of a sodium-glucose cotransporter-2 inhibitor. The treatments studied include oral prednisolone, gut-directed budesonide, mycophenolate mofetil, hydroxychloroquine, and a non-steroidal mineralocorticoid receptor antagonist. Each medication is given according to specific dosing schedules ranging from months to two years. This multi-arm, adaptive trial allows for ongoing adjustments and comparisons of these treatments against the standard care alone. During the study, participants will be monitored regularly over two years with assessments including kidney function tests to measure the rate of change in estimated glomerular filtration rate (eGFR). Visits occur at baseline and every 3 months up to 24 months to track kidney health and treatment effects. Safety and kidney outcomes are carefully evaluated to understand the impact of these therapies on disease progression. The trial aims to provide evidence on effective treatment options to improve long-term kidney outcomes in this high-risk population.