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VX19-NEN-801

Title 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
Therapeutic Area Chronic Kidney Disease, Kidney Diseases, Proteinuria, Glomerular Disease
Principal Investigator Daniel Weiner, MD, MS
Min Age 12 Years
Max Age 60 Years
Gender Any
Contact Katie Ferguson
617-636-4877
kidneytrials@tuftsmedicalcenter.org

Overview

This is a study of the prevalence of APOL1 alleles in adults who are of recent African ancestry or geographic origin. The study will enroll up to a total of approximately 2500 subjects into 2 groups. Group 1 includes subjects with FSGS, and Group 2 includes subjects with other forms of proteinuric nondiabetic CKD. No study drug will be administered.

Study Details

Inclusion Criteria

1. African ancestry or geographic origin, which may include but is not limited to
the following: Black, Caribbean, African American, SubSaharan African, or LatinX (defined
as a person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish
culture or origin).
2. Group 1: FSGS OR  proteinuric nondiabetic Chronic Kidney Disease

Exclusion Criteria

1. Subject has end-stage kidney disease, defined as being on chronic dialysis.
2. Subject has had a kidney transplant.
3. Subject has diabetes mellitus.

Study Requirements

This study includes a single visit. A blood sample will be collected for APOL1 genotyping. A saliva sample will be collected for exploratory use in APOL1 genotyping assay development.