RecruitingPhase 2NCT06794996
Inaxaplin in Participants With Proteinuric APOL1 Mediated Kidney Disease With or Without Comorbidities
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
Sponsor
Vertex Pharmaceuticals Incorporated
Enrollment
45 participants
Start Date
Feb 4, 2025
Study Type
INTERVENTIONAL
Conditions
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).
Eligibility
Min Age: 18 YearsMax Age: 67 Years
Inclusion Criteria2
- 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
Exclusion Criteria2
- Evidence of Focal Segmental Glomerulosclerosis (FSGS) with a known cause other than due to APOL1 risk variants
- Uncontrolled hypertension
Interventions
DRUGInaxaplin
Tablets for Oral Administration.
Locations(35)
View Full Details on ClinicalTrials.gov
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NCT06794996