What You Should Know about This Clinical Research Study

What is a clinical research study?

Clinical research studies, also called clinical trials, are carefully designed research studies conducted in people, usually to determine if an investigational drug is safe and effective, but in this study, we are looking at the effectiveness of an investigational genetic test. We encourage interested people to speak first with their doctor about their eligibility to enroll in a clinical research study. New medicines and ways to test for genetically linked conditions are made possible by the volunteers who participate in clinical research studies.

In most countries, the regulatory health authority, like the FDA in the United States, requires that several phases of clinical research be performed to better understand the safety and effectiveness of new investigational drugs and certain medical devices.

Clinical research studies must be approved by an institutional review board (IRB) or ethics committee (EC). An IRB/EC is a group that is responsible for helping to protect the rights and well-being of study participants.

Can I leave the study if I change my mind?

Participation in any clinical research study is always completely voluntary. Taking part in this study is your choice, and you may leave the study at any time for any reason. You should consult the study doctor and staff about concerns and questions you have at any time during the study.

What should I expect if I choose to take part in this clinical study?

Participation in this study consists of a single visit that can take place at home or at the study site. At this visit, the study doctor and their team will take samples of blood and saliva from you to see if you were born with a variation in your APOL1 gene that may be the cause of your chronic kidney disease (CKD). Those who qualify will receive this investigational testing at no cost. You may also be compensated for your study-related time and reimbursed for travel.

How long will study participation last?

Participation in this study consists of one visit for the blood and saliva sample collection. This investigational genetic test may qualify you for a future clinical research study for people with CKD.

What is the investigational genetic test?

This clinical research study includes investigational genetic testing, which means that the study team is taking samples of blood and saliva to see if you were born with the APOL1 risk variants that are associated with CKD.

The test used to see if you have an APOL1 gene variation is not approved by the regulatory health agency in your country, which means that it is not available outside a research study and is not meant to help you make decisions about your medical care.

Learn more about the study.

See if you may qualify