The trial is taking place at:
P

Prolato Clinical Research Center | Houston, TX

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

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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
2021-004762-35 (EudraCT 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:

  • APOL1 genotype of G1/G1, G2/G2, or G1/G2
  • Proteinuric kidney disease

Key Exclusion Criteria:

  • 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

Other protocol defined Inclusion/Exclusion criteria apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Quadruple Blind

466 participants in 4 patient groups, including a placebo group

Phase 2: VX-147
Experimental group
Description:
Participants will be randomized to receive different dose levels of VX-147.
Treatment:
Drug: VX-147
Phase 2: Placebo
Placebo Comparator group
Description:
Participants will receive placebo matched to VX-147.
Treatment:
Drug: Placebo
Phase 3: VX-147
Experimental group
Description:
Participants will receive VX-147 with the dose to be based on the outcome of Phase 2.
Treatment:
Drug: VX-147
Phase 3: Placebo
Placebo Comparator group
Description:
Participants will receive placebo matched to VX-147.
Treatment:
Drug: Placebo

Trial contacts and locations

237

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Central trial contact

Medical Information

Data sourced from clinicaltrials.gov

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