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Clinical Trials in France / NCT05312879
Active, not recruiting Phase 2/3

Phase 2/3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1-Mediated Proteinuric Kidney Disease

NCT05312879 · tracked via the Priya Life Science France tracker
Sponsor
Vertex Pharmaceuticals Incorporated
Phase
Phase 2/3
Started
2022-03-30
Last updated
2026-10-15

Condition(s) studied

Proteinuric Kidney Disease

Investigational drug(s) / intervention(s)

VX-147Placebo

VX-147: Tablets for oral administration.

Placebo: Tablets for oral administration.

Study summary

The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of VX-147 in adult and pediatric participants with apolipoprotein L1 (APOL1)-mediated proteinuric kidney disease.

Eligibility

Sex
ALL
Min age
10 Years
Max age
65 Years
Healthy volunteers
No
Key Inclusion Criteria: Part A: * APOL1 genotype of G1/G1, G2/G2, or G1/G2 * Proteinuric kidney disease Part B: \- Completion of Treatment Period in Part A and no permanent discontinuation of study drug. Key Exclusion Criteria: Part A: * Solid organ or bone marrow transplant * Uncontrolled hypertension * History of diabetes mellitus * Known underlying cause of kidney disease including but not limited to sickle cell disease Part B: * ESKD (End Stage Kidney Disease) as defined in the protocol. * Any lab abnormality that may pose a safety risk to the participant, as judged by the investigator. Other protocol defined Inclusion/Exclusion criteria will apply.

Primary outcome measure(s)

  • Part A: Percent Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) at Week 48 (Assessed at the Week 48 Interim Analysis) — From Baseline to Week 48
  • Part A: Estimated Glomerular Filtration Rate (eGFR) Slope Assessed at Interim Analysis — From Baseline Through >= Week 48
  • Part A: eGFR Slope Assessed at Final Analysis — From Baseline Through Study Completion (At least 2 years of eGFR data assessed at the final analysis)
  • Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs) — Day 1 Through Study Completion (Approximately 4 Years After the Last Participant Enrolls)

Trial sites (314)

FacilityCityRegionStatus
Alabama Kidney Research Alabaster Alabama
EmVenio Research - Mobile Unit - Birmingham Birmingham Alabama
Cardiology, P.C. Birmingham Alabama
Children's Hospital of Alabama Birmingham Alabama
The Kirklin Clinic - Nephrology Birmingham Alabama
Nephrology Associates Fairhope Alabama
Heart Center Research LLC Huntsville Alabama
Nephrology Consultants, LLC Huntsville Alabama
Renal Associates of Alabama, LLC Montgomery Alabama
Arizona Kidney Disease and Hypertension Center - Thomas Office Phoenix Arizona
Phoenix Children's Hospital, Inc. - Nephrology Phoenix Arizona
CHI St. Vincent Heart Clinic Arkansas- Cardiology and Medicine Clinic - Little Rock Little Rock Arkansas
UAMS Medical Center - Pulmonology Little Rock Arkansas
The Medical Research Group - Saint Agnes Medical Center Fresno California
Amicis Research Center - Balboa Granada Hills California
Kidney Care Center of North Valley Granada Hills California
Eastside Clinical Research Associates Los Angeles California
Kaiser Permanente Los Angeles Medical Center Los Angeles California
Cedars-Sinai Medical Center Los Angeles California
UCLA Division of Nephrology Los Angeles California
UCI Center for Clinical Research Orange California
Kaiser Permanente Sacramento Medical Center Sacramento California
Helen Diller Medical Center at Parnassus Heights San Francisco California
UCLA Lundquist Institute at Harbor-UCLA Medical Center Torrance California
Kidney and Hypertension Center Victorville California
Greater Hartford Nephrology Bloomfield Connecticut
Nephrology & Hypertension Associates, PC Middlebury Connecticut
Yale University - Yale Nephrology Clinical Research Clinic New Haven Connecticut
Children's National Hospital - Nephrology Washington D.C. District of Columbia
The George Washington University - GW Medical Faculty Associates Washington D.C. District of Columbia
Veterans Affairs Medical Center - Washington D.C Washington D.C. District of Columbia
Bay Pines Foundation Bay Pines Florida
Nova Clinical Research, LLC - Bradenton - 59th St Bradenton Florida
Clinical Research of Brandon, LLC Brandon Florida
AMR-Miami Coral Gables Florida
Horizon Research Group - Coral Gables Coral Gables Florida
South Florida Nephrology Research Coral Springs Florida
Delray Physician Care Center Delray Beach Florida
North Florida/South Georgia Veterans Health System Gainesville Florida
Shands Hospital - Nephrology Gainesville Florida

+ 274 more sites — see the full list on the official registry below.

More Vertex Pharmaceuticals Incorporated trials in France

Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age Active, not recruiting
Evaluation of Long-Term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor in Cystic Fibrosis Participants 1 Year of Age and Older Enrolling by invitation
A Safety, Tolerability, and Efficacy Study of VX-880 and VX-017 in Participants With Type 1 Diabetes Recruiting
Phase 2a Study of VX-407 in Participants With ADPKD Who Have a Subset of PKD1 Gene Variants (AGLOW) Active, not recruiting
Polycystic Kidney Disease 1 (PKD1) Gene Variant Groups in Autosomal Dominant Polycystic Kidney Disease Active, not recruiting

Other trials for the same condition

A Phase 2 Study of MZE829 in Adults With APOL1 Kidney Disease Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05312879 on ClinicalTrials.gov ↗ ← All trials in France