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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06794996

Acronym

AMPLIFIED

Enrollment

Registered

2025-01-27

Start date

2025-02-04

Completion date

2026-07-20

Last updated

2026-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proteinuric Kidney Disease

Keywords

APOL1-mediated kidney disease (AMKD)

Brief 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).

Interventions

DRUGInaxaplin

Tablets for Oral Administration.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 67 Years

Healthy volunteers

Inclusion criteria

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/

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 21, 2026