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.