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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
Overall Recruitment Status: Active, not yet recruiting
 
Official 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
 
Region Sponsors
California - Northern
Vertex Pharmaceuticals Incorporated
 
Acronym NCT No.
NCT05312879
 
Study Type Phase
INTERVENTIONAL
Phase II
 
Purpose
The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of VX-147 in participants aged 18 years and older with apolipoprotein L1 (APOL1)-mediated proteinuric kidney disease.
 
Detailed Description
 
 
 
Inclusion Criteria
  • APOL1 genotype of G1/G1, G2/G2, or G1/G2
  • Proteinuric kidney disease
 
Exclusion Criteria
  • Solid organ or bone marrow transplant
  • Uncontrolled hypertension
  • Diagnosis of diabetes mellitus
  • Known underlying cause of kidney disease including but not limited to sickle cell disease
  • Please contact study team, other protocol defined Inclusion/Exclusion criteria apply
 
Keywords and/or Specific Medical Conditions
  • Kidney Diseases
  • VX21-147-301
  • Urologic Diseases
  • Nephrology
 
KP Clinical Facility
  • Sacramento Medical Center
 
Clinical Area
  • Nephrology


Principal Investigator:
Anthony Alvarado , MD
Contact Information:
- CTP Collaborate Team Z , RN
-CTPCollaborate@kp.org
-Sacramento Medical Center


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