Evaluating Veverimer for Adults with Chronic Kidney Disease and Metabolic Acidosis A Phase 3 Randomized Study

What this Trial Is About

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.

A Study to Evaluate the Efficacy and Safety of Veverimer for the Treatment of Metabolic Acidosis