The goal of this study is to learn whether veverimer is safe and helpful in preventing or treating the problems of metabolic acidosis in adults with chronic kidney disease (CKD).
Healthy kidneys help clean your blood. They remove waste and extra fluid and help keep the right balance of minerals, salt, and acids in your body. One way they do this is by making bicarbonate, which helps lower extra acid in the blood. When they are not working well, like in CKD, too much acid can build up in the blood. This condition is called metabolic acidosis. Over time, metabolic acidosis can harm your bones, muscles, and other parts of the body. Without treatment, it can make CKD worse, weaken muscles, make it harder to do daily activities, and raise the risk of broken bones. This study is looking at whether veverimer can raise bicarbonate levels in the blood, help muscle health and physical function, and help slow the worsening of CKD. Before you can join the study, you will go to a visit to see if you qualify. During this visit, the study team will check your vital signs, do a physical exam, ask about your health history, medicines, usual diet, take a blood sample, and do tests that measure your physical performance. If you qualify, you will get either veverimer or a placebo. A placebo looks like the study drug but does not have active drug. You cannot choose which group you are in. Your group will be assigned by chance, like drawing numbers from a hat. If you join the treatment period, you will take veverimer or placebo every day for 24 weeks. Your dose may be increased up to three times a day or lowered during the study, based on your needs. You will also do tests and questionnaires like those done on your first visit. About 2 weeks after your last dose, you will return for a follow-up visit. Your participation in this study will last up to 30 weeks. There is no cost to join the study. You can earn up to $2,325 for your participation in this study.
You may be able to join this study if you are at least 18 years old and have CKD with lower-than-normal bicarbonate levels in your blood. You must also be willing to keep your usual diet consistent throughout the study. You cannot participate if you have taken part in another study involving a study drug within the past 28 days or regularly use cannabis or THC products.
Protocol Number: 25-2612
Principal Investigator