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.

Age: 10 Years to 65 Years old

Gender: All

Start Date: 03/30/2022

Primary Completion Date (Estimated): 06/02/2028

Study Completion Date (Estimated): 05/07/2030

Accepts Healthy Volunteers: No

Trial Purpose and Description

Eligibility Criteria

Age: 10 Years to 65 Years old

Gender: All

Accepts 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.