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Evaluating Inaxaplin for Kidney Disease Related to APOL1 Variants

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

Phase 2 Interventional Vertex Pharmaceuticals Incorporated · NCT06794996

This study is testing if a new treatment called Inaxaplin can help people with kidney disease caused by specific APOL1 gene variants.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment45 (estimated)
Ages18 Years to 67 Years
SexAll
SponsorVertex Pharmaceuticals Incorporated Industry-sponsored
Locations20 sites (Lauderdale Lakes, Florida and 19 other locations)
Trial IDNCT06794996 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy, safety, and tolerability of Inaxaplin in individuals suffering from proteinuric kidney disease linked to APOL1 gene variants. Participants will be monitored for their response to the treatment, which is administered in an open-label format, meaning both the researchers and participants know the treatment being given. The study focuses on patients with specific APOL1 genotypes and a certain level of kidney function, ensuring a targeted approach to this condition.

Who should consider this trial

Good fit: Ideal candidates include individuals with specific APOL1 genotypes and an estimated glomerular filtration rate of 25 mL/min or higher.

Not a fit: Patients with focal segmental glomerulosclerosis from causes other than APOL1 variants or those with uncontrolled hypertension may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve kidney function and quality of life for patients with APOL1-mediated kidney disease.

How similar studies have performed: While this approach is focused on a specific genetic variant, similar studies targeting genetic causes of kidney disease have shown promise, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Lauderdale Lakes, Florida and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Proteinuric Kidney Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.