A Clinical Research Study for Individuals of African Ancestry

Investigational genetic testing can be done to see if you were born with the variation in your APOL1 gene that causes CKD. The study will require blood and saliva samples to determine if you have this gene variation. The results of this investigational genetic test may qualify you for a future clinical research study for individuals with CKD.

The test used to determine if you have an APOL1 gene variation is not approved by the Food and Drug Administration (FDA). This means that it is not available outside a research study and is not intended to drive decisions about your medical care. As with any genetic test, there is a risk of inaccurate results. Vertex, the sponsor of this research study, is making efforts to reduce this risk by testing your blood and saliva samples under industry-standard processes and guidelines. If you would like more information about this investigational genetic test, please ask your study doctor.

We are currently enrolling individuals between the ages of 12 and 60 years old (inclusive) who may be eligible to participate in investigational genetic testing for the APOL1 gene. This clinical research study may be appropriate for those who meet the following criteria:

• Male or female of African ancestry or geographic origin, which may include but is not limited to the following: Black, Caribbean, African American, sub-Saharan African, or LatinX (defined as a person of Cuban, Mexican, Puerto Rican, South or Central American, or similar descent)
• Are between the ages of 12 and 60 years old (inclusive)
• Have diagnosed focal segmental glomerulosclerosis (FSGS) or another form of CKD with an increased level of protein in their urine, and no other identifiable cause of kidney disease, including diabetes
• Willing and able to comply with the testing requirements

Those who qualify will receive this investigational genetic testing at no cost. If you qualify, you may be compensated for your study-related time and reimbursed for travel.

What Is a Clinical Research Study?

Clinical research studies, also called clinical trials, are carefully designed research studies conducted in people to determine if an investigational drug is safe and effective. We encourage interested individuals to speak first with their doctor about their eligibility to enroll in a clinical research study. New medicines are made possible by the volunteers who participate in clinical research studies.

In most countries, the regulatory health authority, such as 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 welfare of study participants.

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 individuals with CKD.

Thank you for your consideration of this important study.