ClinicalTrials.Veeva

Menu

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

Vertex Pharmaceuticals logo

Vertex Pharmaceuticals

Status and phase

Enrolling
Phase 3
Phase 2

Conditions

Proteinuric Kidney Disease

Treatments

Drug: VX-147
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05312879
VX21-147-301
2024-515633-15-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment

466 estimated patients

Sex

All

Ages

10 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Quadruple Blind

466 participants in 3 patient groups, including a placebo group

Part A (Phase 2/3): VX-147
Experimental group
Description:
Participants will be randomized to receive different doses of VX-147. Participants will receive the selected dose of VX-147 for atleast 96 weeks.
Treatment:
Drug: VX-147
Part A (Phase 2/3): Placebo
Placebo Comparator group
Description:
Participants will receive placebo matched to VX-147.
Treatment:
Drug: Placebo
Part B (Phase 3): VX-147
Experimental group
Description:
Participants who complete Part A will receive VX-147 for an additional 96 weeks.
Treatment:
Drug: VX-147

Trial contacts and locations

331

Loading...

Central trial contact

Medical Information

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems