RecruitingPhase 2NCT06794996

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

Sponsor

Vertex Pharmaceuticals Incorporated

Enrollment

45 participants

Start Date

Feb 4, 2025

Study Type

INTERVENTIONAL

Conditions

Proteinuric Kidney Disease

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

Min Age: 18 YearsMax Age: 67 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called inaxaplin for people who have a specific genetic variation (in the APOL1 gene) that can cause kidney disease. People of African descent are more likely to carry this gene variant. The study includes patients who may also have other health conditions alongside their kidney disease. **You may be eligible if...** - You carry two high-risk APOL1 gene variants (G1/G1, G2/G2, or G1/G2), confirmed by genetic testing - Your kidneys are still functioning at a moderate level (eGFR of 25 or higher) - You have protein in your urine (proteinuria), suggesting kidney damage **You may NOT be eligible if...** - Your kidney disease is caused by something other than the APOL1 gene variants (like another known disease) - You have severe, uncontrolled high blood pressure - Other specific medical conditions as determined by the study team Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInaxaplin

Tablets for Oral Administration.

Locations(35)

Nephrology Consultants, LLC

Huntsville, Alabama, United States

Foundation for Sickle Cell Disease Research, LLC

Hollywood, Florida, United States

South Florida Research Institute

Lauderdale Lakes, Florida, United States

Schiff Center for Liver Diseases

Miami, Florida, United States

CTR Oakwater, LLC

Orlando, Florida, United States

Renal Associates, LLC

Columbus, Georgia, United States

Georgia Nephrology - Decatur

Decatur, 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

LCMC Health

Metairie, Louisiana, United States

Ochsner Medical Center - New Orleans - Nephrology

New Orleans, 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

Nephrology Associates, P.C.

Columbus, Mississippi, United States

Nephrology and Hypertension Associates, LTD

Tupelo, Mississippi, United States

DaVita Kidney Care - Las Vegas

Las Vegas, Nevada, United States

Saint Michael's Medical Center - Peter Ho Memorial Clinic

Newark, New Jersey, United States

Rutgers Doctors Office Center

Newark, New Jersey, United States

Scott Research, Inc.

Laurelton, New York, United States

NYC Health + Hospital/Harlem

New York, New York, United States

North Carolina Nephrology P.A. - Cary Office

Cary, North Carolina, United States

UNC Clinical and Translational Research Center

Chapel Hill, North Carolina, United States

Duke University Hospital - Children's Health Center

Durham, North Carolina, United States

Eastern Nephrology Associates - New Bern Office

New Bern, North Carolina, United States

Lewis Katz School of Medicine at Temple University - Section of Nephrology

Philadelphia, Pennsylvania, United States

Columbia Nephrology Associates, PA

Columbia, South Carolina, United States

Carolina Nephrology, PA

Spartanburg, South Carolina, United States

Dallas Renal Group - 2

Dallas, Texas, United States

Dallas Renal Group - 1

Dallas, Texas, United States

Dallas Nephrology Associates - Dallas Landry Office

Dallas, Texas, United States

UTSW Medical Center - Nephrology

Dallas, Texas, United States

Prolato Clinical Research Center

Houston, Texas, United States

Tks Research, P.L.L.C.

Norfolk, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT06794996

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