Phase 2b Open-label Study of Inaxaplin in Participants With Proteinuric APOL1 Mediated Kidney Disease
- Registration Number
- NCT06794996
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- 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).
- Detailed Description
A PHASE 2B, TO EVALUATE THE EFFICACY AND SAFETY OF INAXAPLIN IN SUBJECTS WITH APOL1-MEDIATED PROTEINURIC KIDNEY DISEASE WITH OR WITHOUT COMORBIDITIES
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 45
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IXP (Inaxaplin) Inaxaplin 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.
- Primary Outcome Measures
Name Time Method Percent Change in Urine Albumin-Creatinine Ratio (UACR) Baseline and At Week 13
- Secondary Outcome Measures
Name Time Method Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) From Baseline Up To Week 17
Related Research Topics
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Trial Locations
- Locations (26)
Foundation for Sickle Cell Disease Research, LLC
🇺🇸Hollywood, Florida, United States
South Florida Research Institute
🇺🇸Lauderdale Lakes, Florida, United States
CTR Oakwater, LLC
🇺🇸Orlando, Florida, United States
Renal Associates, LLC
🇺🇸Columbus, Georgia, United States
Javara Inc./Privia Medical Group Georgia, LLC - Fayetteville
🇺🇸Fayetteville, Georgia, United States
Georgia Nephrology
🇺🇸Lawrenceville, Georgia, United States
Javara Inc. /Privia Medical Group Georgia, LLC - Savannah
🇺🇸Savannah, Georgia, United States
Renal Associates of Baton Rouge
🇺🇸Baton Rouge, Louisiana, United States
Northwest Louisiana Nephrology, LLC - Shreveport
🇺🇸Shreveport, Louisiana, United States
Javara Inc./Privia Medical Group, LLC MidAtlantic-Silver Spring, MD
🇺🇸Silver Spring, Maryland, United States
Scroll for more (16 remaining)Foundation for Sickle Cell Disease Research, LLC🇺🇸Hollywood, Florida, United States