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New treatment option 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
ClinicalTrials.gov ID: NCT05312879
What this study is testing
What is VX-147?
VX-147 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for proteinuric kidney disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 65
You may be able to join if
- Key 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
You likely can't join if
- 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.
See the full eligibility criteria
- Key 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Alabaster, Alabama, United States
- Birmingham, Alabama, United States
- Fairhope, Alabama, United States
- Huntsville, Alabama, United States
- Montgomery, Alabama, United States
- Mesa, Arizona, United States
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Fresno, California, United States
- Granada Hills, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Torrance, California, United States
- Victorville, California, United States
- Bloomfield, Connecticut, United States
- Middlebury, Connecticut, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
+ 191 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Alabaster, Alabama, United States; Birmingham, Alabama, United States; Fairhope, Alabama, United States; Huntsville, Alabama, United States; Montgomery, Alabama, United States; Mesa, Arizona, United States and 205 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.