Purpose

This study will evaluate the efficacy, safety and pharmacokinetics (PK) of VX-147 in subjects with apolipoprotein L1 (APOL1)-mediated focal segmental glomerulosclerosis (FSGS).

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • APOL1 genotype of G1/G1, G2/G2, or G1/G2 - FSGS diagnosed by kidney biopsy

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
VX-147
Subjects will receive VX-147 orally at Dose 1 for 2 weeks and at Dose 2 for 11 weeks.
  • Drug: VX-147
    Tablets for oral administration

More Details

Status
Active, not recruiting
Sponsor
Vertex Pharmaceuticals Incorporated

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.