A Study of APOL1 in Individuals with Proteinuric Kidney Disease
Research type
Research Study
Full 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
IRAS ID
278354
Contact name
Kate Bramham
Contact email
Sponsor organisation
Vertex Pharmaceuticals Incorporated
Duration of Study in the UK
1 years, 0 months, 30 days
Research summary
The purpose of this study is to establish a group of patients with FSGS and known APOL1 genotype for identification of potential eligibility in the upcoming phase 2 FSGS Vertex clinical studies. This current study that does not administer investigational drug. The study procedure will take about 30 minutes for a patient and involves taking a single blood test and each participant is going to have testing for APOL1 high risk genotypes.
The apolipoprotein L1 (APOL1) gene is expressed in multiple organs in humans, including the kidney.The biologic function of APOL1 is to protect against parasitic infection (Trypanosoma brucei). Two common sequence variants in APOL1, termed G1 and G2 (i.e., risk alleles) are commonly found in individuals of recent African or Caribbean ancestry.
The study population are the patients with FSGS and of recent African ancestry or origin, who are 18 years old and over.Eligibility will be reviewed and documented by an appropriately qualified member of the investigator’s team before blood samples are collected.
Subjects who meet all of the inclusion criteria and none of the exclusion criteria will be eligible.
Each subject will complete participation in the study within 1 calendar day, and up to approximately 250 subjects will be enrolled.
Each subject will have at least 24 hours to consider their participation in the study.REC name
London - City & East Research Ethics Committee
REC reference
20/LO/0296
Date of REC Opinion
29 Apr 2020
REC opinion
Further Information Favourable Opinion