Phase 2b Open-label Study of Inaxaplin in Participants With Proteinuric APOL1 Mediated Kidney Disease

Launched by VERTEX PHARMACEUTICALS INCORPORATED · Jan 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Inaxaplin (IXP) to see how well it works and how safe it is for people with a specific type of kidney disease known as proteinuric APOL1-mediated kidney disease. This condition can lead to kidney damage, and the researchers want to find out if Inaxaplin can help improve kidney function in affected individuals.

To participate, you need to be between the ages of 65 and 74 and have a specific genetic makeup (APOL1 genotype) that makes you more susceptible to this kidney disease. Additionally, your kidney function, measured by something called the estimated glomerular filtration rate (eGFR), should be at least 25 mL/min. If you join the trial, you can expect to undergo regular check-ups to monitor your health and kidney function while taking the medication. The trial is currently recruiting participants, and if you have any questions or think you might be eligible, it's a good idea to discuss it with your healthcare provider.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 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.