Phase 2a Study of VX-147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis
Glomerulosclerosis, Focal Segmental
About this trial
This is an interventional treatment trial for Glomerulosclerosis, Focal Segmental
Eligibility Criteria
Key Inclusion Criteria:
- APOL1 genotype of G1/G1, G2/G2, or G1/G2
- FSGS diagnosed by kidney biopsy
Key Exclusion Criteria:
- Evidence of non-APOL1-mediated FSGS
- Subjects with known sickle cell disease
- Solid organ or Bone marrow transplant
Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- University of Alabama at Birmingham - The Kirklin Clinic
- California Institute of Renal Research
- The George Washington University Medical Faculty Associates - Kidney Disease & Hypertension
- Howard University Hospital
- Kidney and Hypertension Specialists of Miami
- Florida Premier Research Institute
- Morehouse School of Medicine, Grady Memorial Hospital
- Children's Healthcare of Atlanta
- Georgia Nehphrology
- Central Georgia Kidney Specialists PC
- Renal Associates of Baton Rouge
- Ochsner Medical Center - New Orleans
- Boston Medical Center
- Beth Israel Deaconess Medical Center
- Renal and Transplant Associates of New England, PC
- Paragon Health, PC d/b/a Nephrology Center, PC
- Nephrology and Hypertension Associates, LTD
- St Louis Kidney Care
- Nevada Kidney Disease and Hypertension Centers
- SUNY Downstate
- Urban Family Practice
- Icahn School of Medicine at Mount Sinai
- UNC Kidney Center Division of Nephrology & Hypertension
- Tryon Medical Partners
- Durham Nephrology Associates, PA
- Duke University School of Medicine - Duke Molecular Physiology Institute
- Temple University Hospital
- Children's Hospital of Pittsburgh of UPMC
- Medical University of South Carolina
- South Carolina Nephrology and Hypertension Center, Inc.
- Vanderbilt University VU
- Prolato Clinical Research Center
- Privia Medical Group
- Hopital Henri Mondor
- Hôpital Bicêtre AP-HP
- Bichat Hospital
- Hopitaux Universitaires Est Parisien - Hopital Tenon
- Service de Nephrologie - Hopital Universitaire Necker
- Université Paris-Descartes / Hôpital Européen Georges Pompidou
- GCM Medical Group, PSC
- University Hospitals of Leicester NHS Trust - Leicester General Hospital
- Barts Health NHS Trust
- The Medicines Evaluation Unit
- King's College Hospital NHS Foundation Trust - Guthrie Clinic
Arms of the Study
Arm 1
Experimental
VX-147
All participants received VX-147 at a dosage of 15 mg once daily (qd) for 2 weeks and VX-147 at a dosage of 45 mg qd for 11 weeks. Part A was enrolled in 2 cohorts: Cohort 1 and Cohort 2. Cohort 1 included participants with urine protein to creatinine ratio (UPCR) approximately greater than or equal to (≥) 3 g/g (± 10%) and less than (<) 10 g/g and estimated glomerular filtration rate (eGFR) approximately ≥30 mL/min/1.73 m2 (± 10%). Cohort 2 included participants with UPCR approximately ≥0.8 g/g (± 10%) and <2.7 g/g and eGFR approximately ≥30 mL/min/1.73 m2.