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*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

    medicalinfo@vrtx.com

  • Sponsor organisation

    Vertex Pharmaceuticals Incorporated

  • Eudract number

    2021-004762-35

  • ISRCTN Number

    ISRCTN00000000

  • Clinicaltrials.gov Identifier

    NCT05312879

  • 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