NCT05312879 · Vertex Pharmaceuticals Incorporated
Phase 2/3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1- Mediated Proteinuric Kidney Disease
(AMPLITUDE)
What this study is about
The purpose of this study is to evaluate the effectiveness, safety, tolerability, and how the drug moves through the body (PK) of VX-147 in adult and pediatric participants with apolipoprotein L1 (APOL1)-mediated proteinuric kidney disease.
View original scientific description
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.
Interventions
DRUG
VX-147
Tablets for oral administration.
DRUG
Placebo
Tablets for oral administration.
Primary outcome measures
Part A: Percent Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) at Week 48 (Assessed at the Week 48 Interim Analysis)
Time frame: From Baseline to Week 48
Part A: Estimated Glomerular Filtration Rate (eGFR) Slope Assessed at Interim Analysis
Time frame: From Baseline Through >= Week 48
Part A: eGFR Slope Assessed at Final Analysis
Time frame: From Baseline Through Study Completion (At least 2 years of eGFR data assessed at the final analysis)
Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 Through Study Completion (Approximately 4 Years After the Last Participant Enrolls)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Alabaster, Alabama
- Birmingham, Alabama
- Fairhope, Alabama
- Huntsville, Alabama
- Montgomery, Alabama
- Mesa, Arizona
- Phoenix, Arizona
- Little Rock, Arkansas
- Fresno, California
- Granada Hills, California
- Los Angeles, California
- Orange, California
And 136 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 25, 2026 · Source of record for eligibility and locations