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Active, Not Recruiting

NCT Number: NCT06794996

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Proteinuric Kidney Disease

Age range

18 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nephrology Consultants, LLC, Huntsville, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inaxaplin

Drug

Tablets for Oral Administration.

Other names: IXP, VX-147

Primary outcomes

  1. Percent Change in Urine Albumin-Creatinine Ratio (UACR)

    Time frame: Baseline and At Week 13

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

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

Acronym: AMPLIFIED

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 27, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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