Phase 2b Open-label Study of Inaxaplin in Participants With Proteinuric APOL1 Mediated Kidney Disease (AMPLIFIED)

Vertex Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Proteinuric Kidney Disease

Treatments: Drug: Inaxaplin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06794996

VX24-147-202

Details and patient eligibility

About

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).

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 67 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

IXP (Inaxaplin)

Experimental group

Description:

Participants with proteinuric APOL1-mediated kidney disease (AMKD) and who have either none or 1 of the following comorbidities: Type 2 diabetes mellitus (T2DM) or sickle cell disease (SCD) or human immunodeficiency virus (HIV) or lupus nephritis (LN), will receive a single dose of IXP once daily, for 13 weeks.

Treatment:

Drug: Inaxaplin