Testing VX-147 against a placebo for proteinuric kidney disease
Official title: Phase 2/3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1-Mediated Proteinuric Kidney Disease
A Phase 2/3 Adaptive, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VX-147 in Adult and Pediatric Subjects With APOL1-mediated Proteinuric Kidney Disease
Interventions
VX-147
Tablets for oral administration.
Placebo
Tablets for oral administration.
Canadian Sites (2)
Recherche GCP Research
Montreal, Canada
Women's College Hospital
Toronto, Canada
Eligibility Criteria
See who this study is looking for10 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +APOL1 genotype of G1/G1, G2/G2, or G1/G2
- +Proteinuric kidney disease
- +\- Completion of Treatment Period in Part A and no permanent discontinuation of study drug.
Exclusion
- −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
- −ESKD (End Stage Kidney Disease) as defined in the protocolProtocolThe detailed plan a study must follow.Read more →.
- −Any lab abnormality that may pose a safety risk to the participant, as judged by the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →.
- −Other protocol defined InclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →/Exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → will apply.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more →/3 — a combined study that runs the middle stage and the large comparison stage together.
What is being given or done in this study: VX-147, PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
There are 3 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 10 years to 65 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 466 people.
The study is currently expected to finish around May 2030.
The main measurement is taken over: From BaselineBaselineYour starting measurements, taken before treatment begins.Read more → to Week 48.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Part A: Percent Change From BaselineBaselineYour starting measurements, taken before treatment begins.Read more → in Urine Protein to Creatinine Ratio (UPCR) at Week 48 (Assessed at the Week 48 Interim Analysis) — measured over From Baseline to Week 48.
Part A: Estimated Glomerular Filtration Rate (eGFR) Slope Assessed at Interim Analysis — measured over From Baseline Through >= Week 48.
Part A: eGFR Slope Assessed at Final Analysis — measured over 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 eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AEs) and Serious Adverse EventsSerious adverse eventAn adverse event meeting a formal severity threshold, such as requiring hospital admission.Read more → (SAEs) — measured over Day 1 Through Study Completion (Approximately 4 Years After the Last Participant Enrolls).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05312879 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About VX-147Drug
Tablets for oral administration.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Tablets for oral administration.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 10 years to 65 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 10 years to 65 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From BaselineBaselineYour starting measurements, taken before treatment begins.Read more → to Week 48.
The study as a whole is currently expected to finish around 2030-05-07.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 466 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 18 locations, including: Montreal, Canada; Toronto, Canada; Ann Arbor, Michigan, United States; Detroit, Michigan, United States; Farmington Hills, Michigan, United States; Flint, Michigan, United States, and 12 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (27)
A. Alfred Taubman Health Care Center - Nephrology Clinic at Taubman Center
Ann Arbor, Michigan, United States
Henry Ford Health System - Nephrology
Detroit, Michigan, United States
Quest Research Institute
Farmington Hills, Michigan, United States
AA Medical Research Center
Flint, Michigan, United States
Sparrow Clinical Research Institute
Lansing, Michigan, United States
St. Clair Nephrology Research
Roseville, Michigan, United States
Center for Advanced Kidney Research
Saint Clair Shores, Michigan, United States
InterMed Consultants - Edina Clinic
Edina, Minnesota, United States
Minneapolis VA Healthcare System
Minneapolis, Minnesota, United States
Kings County Hospital
Brooklyn, New York, United States
SUNY Downstate Health Sciences University
Brooklyn, New York, United States
Clindove Research LLC
Brooklyn, New York, United States
New York Presbyterian Queens
Flushing, New York, United States
Zucker School of Medicine
Great Neck, New York, United States
Scott Research, Inc.
Laurelton, New York, United States
VA New York Harbor Healthcare System
New York, New York, United States
Grossman School of Medicine
New York, New York, United States
Synexus Clinical Research - New York (DRS)
New York, New York, United States
The Rogosin Kidney Center
New York, New York, United States
Icahn School of Medicine at Mount Sinai - Nephrology
New York, New York, United States
And 7 more sites worldwide.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.