A Phase 2b, Open-label Study to Evaluate the Efficacy and Safety of Inaxaplin in Subjects With Proteinuric APOL1-mediated Kidney Disease With or Without Comorbidities That May Independently Contribute to Chronic Kidney Disease

The purpose of the study is to evaluate the efficacy, safety, and tolerability of Inaxaplin (IXP) in participants with proteinuric APOL1- mediated kidney disease (AMKD)

CT.gov Identifier
NCT06794996
EudraCT Identifier
N/A
CTIS:
N/A
Sponsor
Vertex Pharmaceuticals
Collaborator
N/A
Study Contact Information
+1 617 341 6100
Recruiting
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Study Details

Diseases
APOL1 Mediated Kidney Disease (AMKD)
Study Drug
Inaxaplin
Genes
APOL1
Study Dates
Feb 2025 - Dec 2026
Sex
Female & Male
Age
18 - 67 Years
Inclusion and Exclusion Criteria
Inclusion Criteria:
  • Key
  • * Participant has an APOL1 genotype of G1/G1, G2/G2, or G1/G2 obtained with a Vertex designated investigational clinical study assay
  • * Estimated Glomerular Filtration Rate (eGFR) of greater than or equal to (≥) 25 milliliter per minute (mL/min)/1.73m\^2 at screening
  • Key
Exclusion Criteria:
  • * Evidence of Focal Segmental Glomerulosclerosis (FSGS) with a known cause other than due to APOL1 risk variants
  • * Uncontrolled hypertension
  • Other protocol defined Inclusion/Exclusion criteria may apply.

Protocol Summary

The purpose of the study is to evaluate the efficacy, safety, and tolerability of Inaxaplin (IXP) in participants with proteinuric APOL1- mediated kidney disease (AMKD)

Study Locations

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