Purpose of the Study

The purpose of this study is to evaluate the safety, tolerability, and effectiveness of an investigational medication in individuals with a type of kidney disease called focal segmental glomerulosclerosis (FSGS) who also have specific changes in the apolipoprotein L1 (APOL1) gene. Specific changes in the APOL1 gene have been shown to contribute to FSGS disease progression. These changes can run in families and are typically present in individuals of African, Caribbean, or Latin American descent. The word “investigational” means this medication is not yet approved for use by the Food and Drug Administration (FDA) in the United States or other regulatory agencies in the UK, Europe, or elsewhere.

Who May Qualify

Eligible participants must meet the following criteria:

• Be male or female between the ages of 18 and 65 (inclusive)
  • Female participants must not be pregnant or nursing
• Be of African, Caribbean, or Latin American descent
• Have had a diagnosis of focal segmental glomerulosclerosis via a kidney biopsy
• Have not had a diagnosis of kidney disease other than FSGS
• Be willing to complete the investigational apolipoprotein 1 (APOL1) gene test
• Be willing and able to comply with the study instructions

There are additional eligibility requirements, which the study doctor can explain to you.

Study Participation

We are looking for adults of African, Caribbean, or Latin American descent between the ages of 18 and 65 with a type of kidney disease called FSGS who also have specific changes in the APOL1 gene to participate in this clinical research study. Testing for the APOL1 gene is included in this clinical study.

Interested individuals will be evaluated during a screening period to determine their eligibility to participate. Your participation could last approximately 17 weeks followed by an optional off-treatment observation period lasting up to 12 weeks. You and your study doctor may choose to have some of the study visits at your home with a home health nurse followed by a telemedicine video visit or phone call with the study doctor, allowing for a reduced number of times that you must travel to the study site.

See if you may qualify

For Families and Caregivers

If your loved one is living with FSGS, share this website with them today, or talk to their doctor for more information.

According to the National Kidney Foundation (NKF), Black individuals and African Americans have an increased risk of kidney failure due to high rates of diabetes, high blood pressure, and heart disease.¹ NKF recommends visiting a physician regularly to check your blood sugar, blood pressure, urine protein, and kidney function. A physician can help detect some of the signs and symptoms of a kidney disease like FSGS that some individuals may not be aware of, such as:²

• Swelling in your legs, in your ankles, and around your eyes
• Weight gain due to extra fluid in your body
• Foamy urine or spilling protein in urine
• High fat levels in the blood (high cholesterol)
• Low levels of protein in the blood

It is important to note that some individuals may not be aware of these symptoms, depending on their disease state, and some symptoms may be detected only by a physician.

Footnotes

1. kidney.org/news/newsroom/factsheets/African-Americans-and-CKD
2. kidney.org/atoz/content/focal