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

April 29, 2026 updated by: Vertex Pharmaceuticals Incorporated

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

A PHASE 2B, TO EVALUATE THE EFFICACY AND SAFETY OF INAXAPLIN IN SUBJECTS WITH APOL1-MEDIATED PROTEINURIC KIDNEY DISEASE WITH OR WITHOUT COMORBIDITIES

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35805
        • Nephrology Consultants, LLC
    • Florida
      • Hollywood, Florida, United States, 33023
        • Foundation for Sickle Cell Disease Research, LLC
      • Lauderdale Lakes, Florida, United States, 33313
        • South Florida Research Institute
      • Miami, Florida, United States, 33136
        • Schiff Center for Liver Diseases
      • Orlando, Florida, United States, 32806
        • CTR Oakwater, LLC
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Renal Associates, LLC
      • Decatur, Georgia, United States, 30030
        • Georgia Nephrology - Decatur
      • Fayetteville, Georgia, United States, 30214
        • Javara Inc./Privia Medical Group Georgia, LLC - Fayetteville
      • Lawrenceville, Georgia, United States, 30046
        • Georgia Nephrology
      • Savannah, Georgia, United States, 31406
        • Javara Inc. /Privia Medical Group Georgia, LLC - Savannah
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Renal Associates of Baton Rouge
      • Metairie, Louisiana, United States, 70006
        • LCMC Health
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center - New Orleans - Nephrology
      • Shreveport, Louisiana, United States, 71101
        • Northwest Louisiana Nephrology, Llc - Shreveport
    • Maryland
      • Silver Spring, Maryland, United States, 20901
        • Javara Inc./Privia Medical Group, LLC MidAtlantic-Silver Spring, MD
    • Mississippi
      • Columbus, Mississippi, United States, 39705
        • Nephrology Associates, P.C.
      • Tupelo, Mississippi, United States, 38801
        • Nephrology and Hypertension Associates, LTD
    • Nevada
      • Las Vegas, Nevada, United States, 89107
        • DaVita Kidney Care - Las Vegas
    • New Jersey
      • Newark, New Jersey, United States, 07102
        • Saint Michael's Medical Center - Peter Ho Memorial Clinic
      • Newark, New Jersey, United States, 07103
        • Rutgers Doctors Office Center
    • New York
      • Laurelton, New York, United States, 11413
        • Scott Research, Inc.
      • New York, New York, United States, 10037
        • NYC Health + Hospital/Harlem
    • North Carolina
      • Cary, North Carolina, United States, 27511
        • North Carolina Nephrology P.A. - Cary Office
      • Chapel Hill, North Carolina, United States, 27599-7155
        • UNC Clinical and Translational Research Center
      • Durham, North Carolina, United States, 27710
        • Duke University Hospital - Children's Health Center
      • New Bern, North Carolina, United States, 28562
        • Eastern Nephrology Associates - New Bern Office
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Lewis Katz School of Medicine at Temple University - Section of Nephrology
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Columbia Nephrology Associates, PA
      • Spartanburg, South Carolina, United States, 29306
        • Carolina Nephrology, PA
    • Texas
      • Dallas, Texas, United States, 75230
        • Dallas Renal Group - 2
      • Dallas, Texas, United States, 75237
        • Dallas Renal Group - 1
      • Dallas, Texas, United States, 75246
        • Dallas Nephrology Associates - Dallas Landry Office
      • Dallas, Texas, United States, 75390
        • UTSW Medical Center - Nephrology
      • Houston, Texas, United States, 77054
        • Prolato Clinical Research Center
    • Virginia
      • Norfolk, Virginia, United States, 23504
        • Tks Research, P.L.L.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Inaxaplin
Tablets for Oral Administration.
Other Names:
  • VX-147
  • IXP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change in Urine Albumin-Creatinine Ratio (UACR)
Time Frame: Baseline and At Week 13
Baseline and At Week 13

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: From Baseline Up To Week 17
From Baseline Up To Week 17

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vertex Pharmaceuticals Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

January 23, 2025

First Submitted That Met QC Criteria

January 23, 2025

First Posted (Actual)

January 27, 2025

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VX24-147-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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