A Study of the Prevalence of Apolipoprotein L1 (APOL1) Alleles Among Individuals With Proteinuric Kidney Disease Who Are of Recent African Ancestry or Geographic Origin.

Phase

N/A

Condition

Kidney Disease

Treatment

N/A

Clinical Study ID

TX400009

VX19-NEN-801

Ages 18-65
All Genders

Study Summary

"If your family has a history of kidney problems, a clinical research study may be an option for you. Doctors around the world are looking for volunteers to undergo an investigational genetic test to see if they were born with a variation in their apolipoprotein L1 (APOL1) gene.

Variations in this gene can cause a genetic kidney disease called APOL1-mediated chronic kidney disease (CKD). This type of genetic variation is most commonly found in people of African ancestry, which may include but is not limited to the following: Black, Caribbean, African American, African, or Latinx (defined as a person of Caribbean, South or Central American, or similar descent)."

Eligibility Criteria

Inclusion

<ul><li>You have nondiabetic [not affected with diabetes (high blood sugar)] chronic kidney disease (CKD) with an increased level of protein in your urine. This has been diagnosed as either Focal Segmental Glomerulosclerosis (FSGS) or another form of nondiabetic CKD. If you are unsure which form of kidney disease you have, you should ask your doctor; or</li><li>You have not been diagnosed with CKD but have a history of lower than normal estimated glomerular filtration rate (eGFR). eGFR measures your kidneyâ€™s ability to filter toxins or waste from your blood. If this value is low, it means that your kidneys are not working as well as they should.</li></ul>

Study Design

October 04, 2022

Study Description

You are invited to take part in this study because: You have nondiabetic [not affected with diabetes (high blood sugar)] chronic kidney disease (CKD) with an increased level of protein in your urine. This has been diagnosed as either Focal Segmental Glomerulosclerosis (FSGS) or another form of nondiabetic CKD. If you are unsure which form of kidney disease you have, you should ask your doctor; orYou have not been diagnosed with CKD but have a history of lower than normal estimated glomerular filtration rate (eGFR). eGFR measures your kidneyâ€™s ability to filter toxins or waste from your blood. If this value is low, it means that your kidneys are not working as well as they should.Due to their genetic makeup, certain people have a higher risk of developing kidney disease. Among other reasons, it can be caused by having a genetic variation (changes in DNA) in a gene called apolipoprotein L1 (APOL1). The purpose of the study is to see if you have an APOL1 genetic variant. The study will also help find people with a genetic variant who may be interested in participating in future research studies.This study will take approximately one hour and involves obtaining your consent, taking a single blood test and providing a saliva sample. You may also be asked to provide a urine sample if you do not have documentation of protein in your urine in the past 12 months. After your visit, you will be contacted by the study staff to share the results of your genetic test.This visit can take place in a research clinic with your Study Doctor or in your own home. For more information, please contact:

Nelson Chen, Senior Clinical Research Coordinator
646-317-0785
nec9039@nyp.org

Connect with a study center

The Rogosin Institute
New York, New York 10021
United States
Active - Recruiting

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