*A Phase 2/3 Adaptive, Double-Blind, Placebo-Controlled Study of VX-147 Aged 18 Years+ AMKD
Research type
Research Study
Full title
A Phase 2/3 Adaptive, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VX-147 in Subjects Aged 18 Years and Older With APOL1-mediated Proteinuric Kidney Disease
IRAS ID
1005379
Contact name
N/A N/A
Contact email
Sponsor organisation
Vertex Pharmaceuticals Incorporated
Eudract number
2021-004762-35
Clinicaltrials.gov Identifier
Research summary
One of the main treatment goals for Chronic Kidney Disease is to reduce or stabilize increased protein levels in the urine. Increases in the amount of protein in the urine may be caused by genetic variation (changes in DNA) in a gene called APOL1. Some people with variants in the APOL1 gene have a higher risk of kidney disease which can have an increased risk of progressive decline in kidney function and end stage kidney disease. This is a Phase 2/3 adaptive, double blind, placebo controlled study for participants aged 18 years of age and older with APOL1-Mediated Kidney Disease to see if the drug is safe, to identify the optimal dose of VX-445, to see if it can reduce the levels of protein in the urine and and if it can help protect the kidneys.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
22/NW/0257
Date of REC Opinion
10 Jun 2022
REC opinion
Further Information Favourable Opinion