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

ConditionProteinuric Kidney Disease

Trial statusRecruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexAll

Age10-65

SponsorVertex Pharmaceuticals Incorporated

About this trial

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 criteria

Qualifiers

APOL1 genotype of G1/G1, G2/G2, or G1/G2

Proteinuric kidney disease

Disqualifiers

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

Trial design

Treatments tested in this trial

VX-147
Placebo

Treatment groups

466 Participants

are divided into 3 treatment groups

Locations

318

Belgium

Universite Catholique de Louvain - Pulmonology Woluwe-Saint-LambertBrussels Capital, Belgium

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg - Pulmonology Leuven Belgium

Brazil

Centro de Pesquisa Clinica do Coracao Aracaju Brazil

Santa Casa de Misericórdia de Belo Horizonte Belo Horizonte Brazil

Sponsors and collaborators

Vertex Pharmaceuticals Incorporated

Lead sponsor

Source ClinicalTrials.gov