Clinical trial NCT06794996: Phase 2b Open-label Study of Inaxaplin in Participants With Proteinuric APOL1 Mediated Kidney Disease
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Proteinuric Kidney Disease
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2025-01-27
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: Percent Change in Urine Albumin-Creatinine Ratio (UACR)
timeFrame: Baseline and At Week 13
Secondary outcomes:
measure: Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From Baseline Up To Week 17
Other outcomes:
Locations:
city: Hollywood
country: United States
facility: Foundation for Sickle Cell Disease Research, LLC
state: Florida
city: Lauderdale Lakes
country: United States
facility: South Florida Research Institute
state: Florida
city: Orlando
country: United States
facility: CTR Oakwater, LLC
state: Florida
city: Columbus
country: United States
facility: Renal Associates, LLC
state: Georgia
city: Fayetteville
country: United States
facility: Javara Inc./Privia Medical Group Georgia, LLC - Fayetteville
state: Georgia
city: Lawrenceville
country: United States
facility: Georgia Nephrology
state: Georgia
city: Savannah
country: United States
facility: Javara Inc. /Privia Medical Group Georgia, LLC - Savannah
state: Georgia
city: Baton Rouge
country: United States
facility: Renal Associates of Baton Rouge
state: Louisiana
city: Shreveport
country: United States
facility: Northwest Louisiana Nephrology, LLC - Shreveport
state: Louisiana
city: Silver Spring
country: United States
facility: Javara Inc./Privia Medical Group, LLC MidAtlantic-Silver Spring, MD
state: Maryland
city: Columbus
country: United States
facility: Nephrology Associates, P.C.
state: Mississippi
city: Tupelo
country: United States
facility: Nephrology and Hypertension Associates, LTD
state: Mississippi
city: Las Vegas
country: United States
facility: DaVita Clinical Research
state: Nevada
city: Newark
country: United States
facility: Saint Michael's Medical Center - Peter Ho Memorial Clinic
state: New Jersey
city: Laurelton
country: United States
facility: Scott Research, Inc.
state: New York
city: New York
country: United States
facility: NYC Health + Hospital/Harlem
state: New York
city: Cary
country: United States
facility: North Carolina Nephrology P.A. - Cary Office
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Clinical and Translational Research Center
state: North Carolina
city: New Bern
country: United States
facility: Eastern Nephrology Associates - New Bern Office
state: North Carolina
city: Columbia
country: United States
facility: Columbia Nephrology Associates, PA
state: South Carolina
city: Spartanburg
country: United States
facility: Carolina Nephrology, PA
state: South Carolina
city: Dallas
country: United States
facility: Dallas Renal Group - 2
state: Texas
city: Dallas
country: United States
facility: Dallas Renal Group - 1
state: Texas
city: Dallas
country: United States
facility: Dallas Nephrology Associates - Dallas Landry Office
state: Texas
city: Houston
country: United States
facility: Prolato Clinical Research Center
state: Texas
city: Norfolk
country: United States
facility: Tks Research, P.L.L.C.
state: Virginia
Study officials:
References: