Status:

COMPLETED

Phase 2a Study of VX-147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis

Lead Sponsor:

Vertex Pharmaceuticals Incorporated

Conditions:

Glomerulosclerosis, Focal Segmental

Eligibility:

All Genders

18-65 years

Phase:

PHASE2

Brief Summary

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

Eligibility Criteria

Inclusion

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

Exclusion

  • Evidence of non-APOL1-mediated FSGS
  • Participants with known sickle cell disease
  • Solid organ or Bone marrow transplant
  • Other protocol defined Inclusion/Exclusion criteria may apply.

Key Trial Info

Start Date :

June 8 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 9 2021

Estimated Enrollment :

16 Patients enrolled

Trial Details

Trial ID

NCT04340362

Start Date

June 8 2020

End Date

December 9 2021

Last Update

September 24 2025

Active Locations (44)

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Page 1 of 11 (44 locations)

1

University of Alabama at Birmingham - The Kirklin Clinic

Birmingham, Alabama, United States, 35294

2

California Institute of Renal Research

San Diego, California, United States, 92123

3

The George Washington University Medical Faculty Associates - Kidney Disease & Hypertension

Washington D.C., District of Columbia, United States, 20037

4

Howard University Hospital

Washington D.C., District of Columbia, United States, 20060