There is a need to find a treatment that addresses the underlying cause of kidney problems. Could you help by taking part in the AMPLITUDE clinical research study?
While there are treatments available to help with the symptoms of APOL1-mediated kidney disease, there are currently no approved treatments that address the underlying cause. This type of kidney disease also runs in the family. Therefore, clinical research is important to try to find a potential treatment that addresses the underlying cause and improves the quality of life of people who are living with kidney problems, and to potentially benefit future generations.
The AMPLITUDE clinical research study is assessing the safety of an investigational study medicine and how well it works at treating APOL1-mediated kidney disease, helping to increase the knowledge of chronic kidney disease and potentially create treatments for future generations. About 466 people are expected to take part and it’s estimated the study will go on for up to 4 years.
You will have appointments at the study site, or you may have the option to be visited by a home health-service provider or to have mobile (remote) visits. There will be more appointments in the first few weeks as you are introduced to the study, then you will have a visit scheduled about every 8 weeks. Before you join, you will be given an informed consent form and other materials to tell you exactly what will be involved throughout the study.
The investigational study medicine in the AMPLITUDE clinical research study is called VX-147. It has been tested in other studies with healthy volunteers and people with a similar type of kidney disease.
The study drug is called ‘investigational’ because it is not yet approved for treating chronic kidney disease by health authorities, such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This clinical research study will help researchers to understand the safety of the investigational study drug and how well it works, and may help in the treatment of chronic kidney disease in the future.
If you choose to take part in the study, you’ll be randomly assigned to receive either the investigational study medicine or placebo. A placebo looks exactly like the investigational study medicine, but doesn’t have any active ingredients.
The investigational study medicine comes in a tablet form and is taken by mouth once a day.
If you have chronic kidney disease and are over the age of 18, you may be able to take part, helping to increase the knowledge of chronic kidney disease and potentially create treatments for people who are impacted by kidney disease. You can see if you meet some of the criteria by answering a few questions.
Interest in this clinical research study is welcomed from all people who meet the requirements of the study, regardless of sex, gender, sexual orientation, race, or religion.
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