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

August 18, 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 4, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 20, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 20, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings