A clinical research study for adults of African, Caribbean, or Central or South American descent.

This clinical research study is investigating if focal segmental glomerulosclerosis (FSGS) is genetic in some patients and is caused by a variation in the apolipoprotein L1 (APOL1) gene. If you are an adult of African, Caribbean, or Central or South American descent and have been diagnosed with FSGS, you may be able to take part.

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About the study.

Investigational genetic testing can be done to see if you were born with the variation in your APOL1 gene that can increase the risk and progression of FSGS. 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 adults with FSGS.

The test used to determine if you have an APOL1 gene variation is not approved by the Food and Drug Administration (FDA) in the United States or any health authorities in other countries. This means that it is not available outside a research study and is not intended to drive decisions about your medical care. If you would like more information about this investigational genetic test, please ask the study doctor.

We are currently enrolling adults 18 years and older who have been diagnosed with biopsy-confirmed FSGS to take part in this clinical research study. It may be appropriate for those who meet the following criteria:

  • Male or female of African, Caribbean, or Central or South American descent
  • Are 18 years of age or older
  • Diagnosed with FSGS via a previously done kidney biopsy
  • 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.

Find a participating site.

Enter your zip code below or click on the map to find the participating research site(s) nearest you.

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About FSGS.

FSGS is a disease that scars the kidney, often leading to kidney failure. FSGS can have many different causes, including infection, disease, some medications, and genetics. If you are of African, Caribbean, or Central or South American descent, it is possible that your condition is genetic and caused by a variation in the apolipoprotein L1 (APOL1) gene. APOL1 is believed to contribute to FSGS disease progression.

What you should know about clinical research studies.

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 medicine 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 determine the safety and effectiveness of investigational drugs and certain investigational 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. The investigational genetic test may qualify you for a future clinical research study for adults with FSGS.

Thank you for your consideration of this important study.

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