Nadiad

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 studying felzartamab in adults with Immunoglobulin A nephropathy IgAN, a kidney disease caused by abnormal IgA antibodies building up in the kidneys leading to inflammation and damage. This Phase 3 clinical trial aims to understand how felzartamab affects proteinuria, the presence of protein in urine, and kidney function in people with IgAN. The safety and how the body processes felzartamab are also being evaluated. Participants will be randomly assigned to receive either felzartamab or a placebo through intravenous infusions during a 24-week treatment period. Some participants with lower kidney filtration rates will be grouped separately but also receive either felzartamab or placebo. After treatment, participants will enter an 80-week follow-up phase. In total, participants will have 17 study visits over about two years. Throughout the study, participants will have urine tests to measure proteinuria, blood tests to assess kidney filtration function, and monitoring for side effects. Researchers will also study felzartamab levels in the blood and check for immune reactions against the drug. Safety will be closely monitored using vital signs, laboratory tests, and physical exams during the entire 104-week period.

Researchers are evaluating the safety and effectiveness of darolutamide alongside standard androgen deprivation therapy ADT in Indian men with high-risk non-metastatic castration-resistant prostate cancer nmCRPC. This type of prostate cancer continues to progress despite very low testosterone levels. The study aims to collect detailed safety data and compare it with previous research involving darolutamide, which did not include Indian participants. Participants will take darolutamide tablets orally twice daily along with their ongoing ADT. They will have visits every 16 weeks from the start until their cancer worsens, they develop medical issues, leave the study, or the study ends. During these visits, various tests and assessments will be performed, including blood and urine sampling, physical exams, heart activity monitoring with ECG, and evaluation of daily living abilities using the ECOG performance status. Throughout the study, researchers will monitor adverse events, lab abnormalities, vital signs, and changes in participants health status up to approximately 15 months. They will also assess changes in prostate-specific antigen PSA levels and track the time to additional cancer treatments. Participants may continue darolutamide after the trial if they benefit from it. The total study duration extends up to the primary completion date in April 2027.

Researchers are evaluating the effects of a medicine called BI 690517 combined with empagliflozin in adults with chronic kidney disease CKD who are at risk of their kidney condition getting worse. The study includes people with or without type 2 diabetes and those who may already be taking medicines like angiotensin converting enzyme inhibitors ACEi, angiotensin receptor blockers ARB, or sodium-glucose cotransporter-2 inhibitors SGLT2i. The goal is to understand if adding BI 690517 can help delay worsening kidney function, hospitalizations due to heart failure, or cardiovascular death. After a run-in period where all participants take empagliflozin and other standard medications, participants are randomly assigned to receive either BI 690517 tablets or placebo tablets once daily alongside empagliflozin. The run-in period confirms that participants are stabilized on empagliflozin before randomization. The treatment phase continues for about three to four years until enough kidney or heart-related events have occurred to compare outcomes between the two groups. During the study, participants visit the study site about five times in the first six months and then every six months thereafter. At these visits, health is regularly checked through blood and urine tests, blood pressure and weight measurements, kidney function monitoring, and collection of any side effect information. The main outcome measured is the time until the first occurrence of kidney disease progression, hospitalization for heart failure, or cardiovascular death.

Researchers are studying the safety, effectiveness, and how the body processes the investigational drug WAL0921 in adults with various glomerular kidney diseases and proteinuria. These include diabetic nephropathy and rare conditions such as primary focal segmental glomerulosclerosis, treatment-resistant minimal change disease, primary immunoglobulin A nephropathy, and primary membranous nephropathy. This is a Phase 2, randomized, double-blind, placebo-controlled study conducted at multiple centers to evaluate WAL0921 compared to a placebo. Participants will be randomly assigned to receive either the investigational drug WAL0921 or a placebo through an intravenous infusion every two weeks for a total of seven infusions. The study includes a treatment period followed by a 24-week follow-up after the last infusion to monitor participants. The treatments are given in parallel groups to compare their effects and safety. During the study, participants will undergo regular assessments including monitoring for adverse events from the start through Week 36. Researchers will also measure changes in albuminuria, proteinuria, and kidney function markers such as estimated glomerular filtration rate over 24 weeks. These evaluations help determine how the drug affects kidney disease markers and overall safety. The total participation time includes treatment and follow-up periods lasting several months.

Chronic kidney disease CKD is a major cause of death worldwide, with a rising impact in South Asia. In this region, one in seven adults has CKD, and IgA nephropathy IgAN is the most common primary glomerular disease affecting adults. Studies show South Asians with IgAN experience severe and rapid kidney function decline. Recent trials indicate that steroids benefits may fade over time, highlighting the need for longer-term treatment options. This trial aims to evaluate commonly available generic drugs alongside standard care to improve kidney outcomes in South Asian adults with biopsy-proven IgAN at high risk of progression. The trial is a multi-center, randomized, single-blind, multi-arm, and multi-stage platform study comparing several drugs added to standard care SoC against SoC alone. SoC includes maximal tolerated doses of ACE inhibitors or angiotensin receptor blockers and a steady dose of SGLT2 inhibitors. The drugs studied include low-dose oral prednisolone, gut-directed budesonide, mycophenolate mofetil, hydroxychloroquine, and a non-steroidal mineralocorticoid receptor antagonist, with dosing schedules ranging from two months to 24 months. The trial allows adaptive changes, including adding new treatment arms based on interim analyses. Participants will be adults aged 18 to 65 with biopsy-proven primary IgAN and specific kidney function and proteinuria criteria despite standard treatment. They will undergo regular assessments over 24 months, including kidney function tests eGFR, proteinuria measurements, medication adherence, and patient-reported outcomes. The primary outcome is the change in the annualized eGFR slope over two years. Secondary outcomes include changes in proteinuria, disease progression markers, adverse events, and quality of life measures. Safety and treatment effects will be closely monitored throughout the study period.