Inaxaplin in Participants With Proteinuric APOL1 Mediated Kidney Disease With or Without Comorbidities
AMPLIFIED
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
1 other identifier
interventional
42
1 country
35
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2025
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2025
CompletedFirst Posted
Study publicly available on registry
January 27, 2025
CompletedStudy Start
First participant enrolled
February 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
May 5, 2026
November 1, 2025
1.9 years
January 23, 2025
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change in Urine Albumin-Creatinine Ratio (UACR)
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)
From Baseline Up To Week 17
Study Arms (1)
IXP (Inaxaplin)
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Evidence of Focal Segmental Glomerulosclerosis (FSGS) with a known cause other than due to APOL1 risk variants
- Uncontrolled hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Nephrology Consultants, LLC
Huntsville, Alabama, 35805, United States
Foundation for Sickle Cell Disease Research, LLC
Hollywood, Florida, 33023, United States
South Florida Research Institute
Lauderdale Lakes, Florida, 33313, United States
Schiff Center for Liver Diseases
Miami, Florida, 33136, United States
CTR Oakwater, LLC
Orlando, Florida, 32806, United States
Renal Associates, LLC
Columbus, Georgia, 31904, United States
Georgia Nephrology - Decatur
Decatur, Georgia, 30030, United States
Javara Inc./Privia Medical Group Georgia, LLC - Fayetteville
Fayetteville, Georgia, 30214, United States
Georgia Nephrology
Lawrenceville, Georgia, 30046, United States
Javara Inc. /Privia Medical Group Georgia, LLC - Savannah
Savannah, Georgia, 31406, United States
Renal Associates of Baton Rouge
Baton Rouge, Louisiana, 70808, United States
LCMC Health
Metairie, Louisiana, 70006, United States
Ochsner Medical Center - New Orleans - Nephrology
New Orleans, Louisiana, 70121, United States
Northwest Louisiana Nephrology, LLC - Shreveport
Shreveport, Louisiana, 71101, United States
Javara Inc./Privia Medical Group, LLC MidAtlantic-Silver Spring, MD
Silver Spring, Maryland, 20901, United States
Nephrology Associates, P.C.
Columbus, Mississippi, 39705, United States
Nephrology and Hypertension Associates, LTD
Tupelo, Mississippi, 38801, United States
DaVita Kidney Care - Las Vegas
Las Vegas, Nevada, 89107, United States
Saint Michael's Medical Center - Peter Ho Memorial Clinic
Newark, New Jersey, 07102, United States
Rutgers Doctors Office Center
Newark, New Jersey, 07103, United States
Scott Research, Inc.
Laurelton, New York, 11413, United States
NYC Health + Hospital/Harlem
New York, New York, 10037, United States
North Carolina Nephrology P.A. - Cary Office
Cary, North Carolina, 27511, United States
UNC Clinical and Translational Research Center
Chapel Hill, North Carolina, 27599-7155, United States
Duke University Hospital - Children's Health Center
Durham, North Carolina, 27710, United States
Eastern Nephrology Associates - New Bern Office
New Bern, North Carolina, 28562, United States
Lewis Katz School of Medicine at Temple University - Section of Nephrology
Philadelphia, Pennsylvania, 19140, United States
Columbia Nephrology Associates, PA
Columbia, South Carolina, 29203, United States
Carolina Nephrology, PA
Spartanburg, South Carolina, 29306, United States
Dallas Renal Group - 2
Dallas, Texas, 75230, United States
Dallas Renal Group - 1
Dallas, Texas, 75237, United States
Dallas Nephrology Associates - Dallas Landry Office
Dallas, Texas, 75246, United States
UTSW Medical Center - Nephrology
Dallas, Texas, 75390, United States
Prolato Clinical Research Center
Houston, Texas, 77054, United States
Tks Research, P.L.L.C.
Norfolk, Virginia, 23504, United States
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2025
First Posted
January 27, 2025
Study Start
February 4, 2025
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
December 30, 2026
Last Updated
May 5, 2026
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share
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/