Chubbuck

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 use of veverimer in adults with moderate-to-severe chronic kidney disease CKD who also have metabolic acidosis. This Phase 3 study aims to assess both the effectiveness and safety of veverimer for treating this condition. The study is sponsored by Renibus Therapeutics, Inc. and involves random assignment of participants to different treatment groups. Participants receive either veverimer or a placebo, both given at a dose of 9 grams twice daily. The study uses a parallel design and is quadruple masked to ensure unbiased results. The primary treatment period lasts up to 168 days, during which participants are monitored closely. The study assesses changes in serum bicarbonate concentration and physical performance, among other health measures. Throughout the study, participants will have blood tests and physical performance assessments, such as the Sit-to-Stand 5 times test. Researchers will track safety by monitoring adverse events and evaluate frailty and muscle mass. Participants are expected to maintain consistent food intake and stable use of other medications during the study. The entire participation period includes screening and follow-up visits to carefully measure treatment effects and safety.

Alport syndrome AS is a rare genetic disorder caused by changes in specific genes that produce collagen, leading to kidney disease, hearing loss, and eye problems. People with AS face a high risk of chronic kidney disease CKD, which gradually reduces kidney function and can lead to end-stage kidney disease. A common sign of worsening kidney function is proteinuria, the presence of excess protein in the urine. This study evaluates the effects of BAY 3401016, a monoclonal antibody designed to block the protein Semaphorin 3A Sema3A, which may contribute to kidney damage in AS. Participants are randomly assigned to receive either BAY 3401016 or a placebo once weekly for 24 weeks, alongside their background therapy. The study includes an extension phase to further assess the treatments safety and efficacy. Participants will be involved for at least 24 weeks of treatment, followed by a 90-day follow-up period. Researchers will monitor kidney function by measuring the urinary albumin creatinine ratio UACR at several points during treatment and after its completion. Safety and tolerability of BAY 3401016 will also be carefully assessed throughout the study period.

Researchers are evaluating the impact of iptacopan treatment on adult patients with Immunoglobulin A Nephropathy IgAN. This study focuses on changes in kidney tissue and immune system markers related to the disease and aims to better understand the treatments effects on both systemic and kidney-specific aspects of IgAN. The trial is designed as a Phase 2, open-label, single-group study led by Novartis Pharmaceuticals. Participants will undergo a screening period followed by a baseline kidney biopsy. Eligible individuals receive iptacopan 200 mg twice daily orally for a 9-month treatment period without dose adjustments. At the end of treatment, a follow-up kidney biopsy is conducted to assess changes. Throughout the study, participants remain on their maximum tolerated or locally approved doses of ACE inhibitors or angiotensin receptor blockers. During the trial, participants will have kidney biopsies at baseline and at 9 months to evaluate complement activation and other markers of kidney function and disease progression. Researchers will monitor clinical and molecular biomarkers, including mesangial C3c deposition and CD68 cells. The study measures the proportion of participants achieving significant reductions in complement deposits, alongside changes in immunoglobulin staining. The total participation time extends through the 9-month treatment and follow-up biopsy.