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

Last updated: August 8, 2025
Sponsor: Vertex Pharmaceuticals Incorporated
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Inaxaplin

Clinical Study ID

NCT06794996
VX24-147-202
  • Ages 18-67
  • All Genders

Study 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 Criteria

Inclusion

Key Inclusion Criteria:

  • Participant has an APOL1 genotype of G1/G1, G2/G2, or G1/G2 obtained with a Vertexdesignated investigational clinical study assay

  • Estimated Glomerular Filtration Rate (eGFR) of greater than or equal to (≥) 25milliliter per minute (mL/min)/1.73m^2 at screening

Exclusion

Key Exclusion Criteria:

  • Evidence of Focal Segmental Glomerulosclerosis (FSGS) with a known cause other thandue to APOL1 risk variants

  • Uncontrolled hypertension

Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 45
Treatment Group(s): 1
Primary Treatment: Inaxaplin
Phase: 2
Study Start date:
February 04, 2025
Estimated Completion Date:
December 30, 2026

Connect with a study center

  • Nephrology Consultants, LLC

    Huntsville, Alabama 35805
    United States

    Active - Recruiting

  • Foundation for Sickle Cell Disease Research, LLC

    Hollywood, Florida 33023
    United States

    Active - Recruiting

  • South Florida Research Institute

    Lauderdale Lakes, Florida 33313
    United States

    Active - Recruiting

  • CTR Oakwater, LLC

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Renal Associates, LLC

    Columbus, Georgia 31904
    United States

    Active - Recruiting

  • Javara Inc./Privia Medical Group Georgia, LLC - Fayetteville

    Fayetteville, Georgia 30214
    United States

    Active - Recruiting

  • Georgia Nephrology

    Lawrenceville, Georgia 30046
    United States

    Active - Recruiting

  • Javara Inc. /Privia Medical Group Georgia, LLC - Savannah

    Savannah, Georgia 31406
    United States

    Active - Recruiting

  • Renal Associates of Baton Rouge

    Baton Rouge, Louisiana 70808
    United States

    Active - Recruiting

  • LCMC Health

    Metairie, Louisiana 70006
    United States

    Active - Recruiting

  • Ochsner Medical Center - New Orleans - Nephrology

    New Orleans, Louisiana 70121
    United States

    Active - Recruiting

  • Northwest Louisiana Nephrology, LLC - Shreveport

    Shreveport, Louisiana 71101
    United States

    Active - Recruiting

  • Javara Inc./Privia Medical Group, LLC MidAtlantic-Silver Spring, MD

    Silver Spring, Maryland 20901
    United States

    Active - Recruiting

  • Nephrology Associates, P.C.

    Columbus, Mississippi 39705
    United States

    Active - Recruiting

  • Nephrology and Hypertension Associates, LTD

    Tupelo, Mississippi 38801
    United States

    Active - Recruiting

  • DaVita Clinical Research

    Las Vegas, Nevada 89107
    United States

    Active - Recruiting

  • Saint Michael's Medical Center - Peter Ho Memorial Clinic

    Newark, New Jersey 07102
    United States

    Active - Recruiting

  • Scott Research, Inc.

    Laurelton, New York 11413
    United States

    Active - Recruiting

  • NYC Health + Hospital/Harlem

    New York, New York 10037
    United States

    Active - Recruiting

  • North Carolina Nephrology P.A. - Cary Office

    Cary, North Carolina 27511
    United States

    Active - Recruiting

  • UNC Clinical and Translational Research Center

    Chapel Hill, North Carolina 27599-7155
    United States

    Active - Recruiting

  • Eastern Nephrology Associates - New Bern Office

    New Bern, North Carolina 28562
    United States

    Active - Recruiting

  • Columbia Nephrology Associates, PA

    Columbia, South Carolina 29203
    United States

    Active - Recruiting

  • Carolina Nephrology, PA

    Spartanburg, South Carolina 29306
    United States

    Active - Recruiting

  • Dallas Nephrology Associates - Dallas Landry Office

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • Dallas Renal Group - 1

    Dallas, Texas 75237
    United States

    Active - Recruiting

  • Dallas Renal Group - 2

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • UTSW Medical Center - Nephrology

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • Prolato Clinical Research Center

    Houston, Texas 77054
    United States

    Active - Recruiting

  • Tks Research, P.L.L.C.

    Norfolk, Virginia 23504
    United States

    Active - Recruiting

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