Inaxaplin in Participants With Proteinuric APOL1 Mediated Kidney Disease With or Without Comorbidities

NCT ID: NCT06794996

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-04

Study Completion Date

2026-12-30

Brief Summary

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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).

Detailed Description

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Conditions

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Proteinuric Kidney Disease

Keywords

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APOL1-mediated kidney disease (AMKD)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IXP (Inaxaplin)

Participants with proteinuric APOL1-mediated kidney disease (AMKD) with or without the comorbidity of Type 2 diabetes mellitus (T2DM) will receive a single dose of IXP once daily, for 13 weeks.

Group Type EXPERIMENTAL

Inaxaplin

Intervention Type DRUG

Tablets for Oral Administration.

Interventions

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Inaxaplin

Tablets for Oral Administration.

Intervention Type DRUG

Other Intervention Names

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IXP VX-147

Eligibility Criteria

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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

Exclusion Criteria

* Evidence of Focal Segmental Glomerulosclerosis (FSGS) with a known cause other than due to APOL1 risk variants
* Uncontrolled hypertension
Minimum Eligible Age

18 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nephrology Consultants, LLC

Huntsville, Alabama, United States

Site Status RECRUITING

Foundation for Sickle Cell Disease Research, LLC

Hollywood, Florida, United States

Site Status COMPLETED

South Florida Research Institute

Lauderdale Lakes, Florida, United States

Site Status RECRUITING

Schiff Center for Liver Diseases

Miami, Florida, United States

Site Status RECRUITING

CTR Oakwater, LLC

Orlando, Florida, United States

Site Status RECRUITING

Renal Associates, LLC

Columbus, Georgia, United States

Site Status RECRUITING

Georgia Nephrology - Decatur

Decatur, Georgia, United States

Site Status RECRUITING

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

Fayetteville, Georgia, United States

Site Status RECRUITING

Georgia Nephrology

Lawrenceville, Georgia, United States

Site Status RECRUITING

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

Savannah, Georgia, United States

Site Status RECRUITING

Renal Associates of Baton Rouge

Baton Rouge, Louisiana, United States

Site Status RECRUITING

LCMC Health

Metairie, Louisiana, United States

Site Status RECRUITING

Ochsner Medical Center - New Orleans - Nephrology

New Orleans, Louisiana, United States

Site Status RECRUITING

Northwest Louisiana Nephrology, LLC - Shreveport

Shreveport, Louisiana, United States

Site Status RECRUITING

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

Silver Spring, Maryland, United States

Site Status RECRUITING

Nephrology Associates, P.C.

Columbus, Mississippi, United States

Site Status RECRUITING

Nephrology and Hypertension Associates, LTD

Tupelo, Mississippi, United States

Site Status RECRUITING

DaVita Clinical Research

Las Vegas, Nevada, United States

Site Status RECRUITING

Saint Michael's Medical Center - Peter Ho Memorial Clinic

Newark, New Jersey, United States

Site Status RECRUITING

Rutgers Doctors Office Center

Newark, New Jersey, United States

Site Status RECRUITING

Scott Research, Inc.

Laurelton, New York, United States

Site Status RECRUITING

NYC Health + Hospital/Harlem

New York, New York, United States

Site Status RECRUITING

North Carolina Nephrology P.A. - Cary Office

Cary, North Carolina, United States

Site Status RECRUITING

UNC Clinical and Translational Research Center

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Duke University Hospital - Children's Health Center

Durham, North Carolina, United States

Site Status RECRUITING

Eastern Nephrology Associates - New Bern Office

New Bern, North Carolina, United States

Site Status RECRUITING

Lewis Katz School of Medicine at Temple University - Section of Nephrology

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Columbia Nephrology Associates, PA

Columbia, South Carolina, United States

Site Status RECRUITING

Carolina Nephrology, PA

Spartanburg, South Carolina, United States

Site Status RECRUITING

Dallas Renal Group - 2

Dallas, Texas, United States

Site Status RECRUITING

Dallas Renal Group - 1

Dallas, Texas, United States

Site Status RECRUITING

Dallas Nephrology Associates - Dallas Landry Office

Dallas, Texas, United States

Site Status RECRUITING

UTSW Medical Center - Nephrology

Dallas, Texas, United States

Site Status RECRUITING

Prolato Clinical Research Center

Houston, Texas, United States

Site Status RECRUITING

Tks Research, P.L.L.C.

Norfolk, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Medical Information

Role: CONTACT

Phone: 617-341-6777

Email: [email protected]

Other Identifiers

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VX24-147-202

Identifier Type: -

Identifier Source: org_study_id