Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
AMPLITUDE
A Phase 2/3 Adaptive, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VX-147 in Subjects Aged 12 Years and Older With APOL1-mediated Proteinuric Kidney Disease.
Brief Description
The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of VX-147 in participants aged 12 years and older with apolipoprotein L1 (APOL1)-mediated proteinuric kidney disease.
Site Name
Icahn School of Medicine at Mount Sinai
New York, NY
Sponsor
Vertex
Study Drug
VX-147-301
Estimated enrollment
466
Estimated end date
2027
Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
AMPLITUDE
A Phase 2/3 Adaptive, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VX-147 in Subjects Aged 12 Years and Older With APOL1-mediated Proteinuric Kidney Disease.
Brief Description
The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of VX-147 in participants aged 12 years and older with apolipoprotein L1 (APOL1)-mediated proteinuric kidney disease.
Trial is for people with
Key Inclusion Criteria:
• APOL1 genotype assessed during screening, participants must have of G1/G1, G2/G2, or G1/G2
• Proteinuric(protein in the urine) kidney disease
Key Exclusion Criteria:
• History of diabetes mellitus(type 1 or type 2)
• Uncontrolled hypertension
• Solid organ or bone marrow transplant
• Known underlying cause of kidney disease including but not limited to sickle cell disease
Other protocol defined Inclusion/Exclusion criteria apply.
About the drug or intervention
The AMPLITUDE clinical research study is exploring an investigational study drug called VX-147 to learn more about how well it works as a treatment for people living with APOL1-mediated kidney disease. VX-147 has been tested in other studies with healthy volunteers and other people with a similar type of kidney disease.