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

  • STATUS
    Recruiting
  • sponsor
    Vertex Pharmaceuticals Incorporated
Updated on 29 July 2021
diabetes

Summary

A Study of the Prevalence of Apolipoprotein L1 (APOL1) Alleles Among Individuals With Proteinuric Kidney Disease

Description

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 2 groups of up to approximately 250 subjects each.

Group 1 includes subjects with FSGS, and Group 2 includes subjects with pNDKD. No study drug will be administered. A blood sample will be collected for APOL1 genotyping. A saliva sample will be collected for exploratory use in APOL1 genotyping assay development.

Details
Condition Proteinuria, Kidney Disease
Clinical Study IdentifierTX278499
SponsorVertex Pharmaceuticals Incorporated
Last Modified on29 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Willing to sign and date an informed consent form (ICF) or provide electronic informed consent, as applicable by local law
Males and females with FSGS or pNDKD who are ≥18 years old
Subject is of African ancestry or geographic origin, which may include but is not limited to the following: Black, Caribbean, African American, SubSaharan African, or LatinX
Subjects must meet one of the below criteria: a.) Group 1: Biopsy-proven FSGS; b.) Group 2: Presence of chronic NDKD (defined as having kidney disease that is not attributable to infection, neoplasia, drugs, immunological disorders or diabetes)
Subject must have previously documented proteinuria as follows: a.) Group 1: urine protein to creatinine ratio ≥1 g/g or proteinuria of ≥1 g/24 h; b.) Group 2: urine protein to creatinine ratio ≥0.1 g/g or proteinuria of ≥0.1 g/24 h

Exclusion Criteria

Subject, or close relative of the subject, is the investigator or a subinvestigator, research assistant, study coordinator, or other staff directly involved with the conduct of the study at that site
Subject has end-stage kidney disease, defined as being on chronic dialysis
Subject has had a kidney transplant
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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