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Small Molecule

VX-147 for Kidney Disease (AMPLITUDE Trial)

Phase 2 & 3
Recruiting
Research Sponsored by Vertex Pharmaceuticals Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Proteinuric kidney disease
APOL1 genotype of G1/G1, G2/G2, or G1/G2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline through study completion (approximately 2 years after the last participant enrolls)
Awards & highlights

AMPLITUDE Trial Summary

This trial will study if VX-147 is an effective, safe, and tolerable treatment for adults with APOL1-mediated kidney disease. The drug's PK will also be analyzed.

Who is the study for?
This trial is for adults and kids with a genetic form of kidney disease linked to APOL1 genes. Participants should have protein in their urine, indicating kidney issues, but can't have diabetes, other known causes of kidney disease like sickle cell, uncontrolled high blood pressure, or a history of organ or bone marrow transplants.Check my eligibility
What is being tested?
The study is testing VX-147's effectiveness and safety compared to a placebo (a treatment with no active drug) in treating APOL1-mediated proteinuric kidney disease. It will also look at how the body processes the drug.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones may include reactions at the site where the drug is given, changes in blood tests that monitor kidney function, allergic reactions to ingredients in VX-147 or general medication-related symptoms such as nausea or headaches.

AMPLITUDE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a kidney condition that causes protein in my urine.
Select...
My genetic test shows I have the APOL1 G1/G1, G2/G2, or G1/G2 variant.

AMPLITUDE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline through study completion (approximately 2 years after the last participant enrolls)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline through study completion (approximately 2 years after the last participant enrolls) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Estimated Glomerular Filtration Rate (eGFR) Slope Assessed at the Week 48 Interim Analysis
Percent Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) at Week 48 (Assessed at the Week 48 Interim Analysis)
eGFR Slope Assessed at Study Completion
Secondary outcome measures
Acceptability Tablet Formulation of VX-147 in Pediatric Participants using the Convenience Domain of the Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4
Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-147
Maximum Plasma Concentration (Cmax) of VX-147
+3 more

Side effects data

From 2021 Phase 2 trial • 16 Patients • NCT04340362
23%
Headache
23%
Back pain
15%
Fatigue
15%
Dyspepsia
15%
Blood bicarbonate decreased
15%
Nausea
15%
Dizziness
8%
Diarrhoea
8%
Gastrooesophageal reflux disease
8%
Abdominal pain lower
8%
Upper respiratory tract infection
8%
Uterine leiomyoma
8%
Abdominal distension
8%
COVID-19
8%
Palpitations
8%
Deep vein thrombosis
8%
Peripheral swelling
8%
Thinking abnormal
8%
Pollakiuria
8%
Muscle spasms
8%
Pain in extremity
8%
Synovitis
8%
Tooth abscess
8%
Urinary tract infection
8%
Vulvovaginal mycotic infection
8%
Vaccination complication
8%
Blood creatine phosphokinase increased
8%
Gamma-glutamyltransferase increased
8%
Musculoskeletal chest pain
8%
Depressed mood
8%
Eczema
8%
Dry skin
8%
Transaminases increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
VX-147: Cohort 2
VX-147 : Cohort 1
VX-147 Total

AMPLITUDE Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Phase 3: VX-147Experimental Treatment1 Intervention
Participants will receive VX-147 with the dose to be based on the outcome of Phase 2.
Group II: Phase 2: VX-147Experimental Treatment1 Intervention
Participants will be randomized to receive different dose levels of VX-147.
Group III: Phase 2: PlaceboPlacebo Group1 Intervention
Participants will receive placebo matched to VX-147.
Group IV: Phase 3: PlaceboPlacebo Group1 Intervention
Participants will receive placebo matched to VX-147.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VX-147
2020
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedLead Sponsor
243 Previous Clinical Trials
31,921 Total Patients Enrolled

Media Library

VX-147 (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT05312879 — Phase 2 & 3
Kidney Disease Research Study Groups: Phase 2: VX-147, Phase 2: Placebo, Phase 3: VX-147, Phase 3: Placebo
Kidney Disease Clinical Trial 2023: VX-147 Highlights & Side Effects. Trial Name: NCT05312879 — Phase 2 & 3
VX-147 (Small Molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05312879 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial being run in a significant number of places throughout North America?

"Currently, 47 clinical trial sites are operational. These locations include Northwest Louisiana Nephrology in Shreveport, The Kidney Institute of Florida in Cape Coral, and The Medical Research Group Inc. in Fresno."

Answered by AI

Are there any availability for participants in this clinical trial?

"That is accurate, the online information does show that this study is open for recruitment. This clinical trial was originally posted on March 30th, 2022 and updated October 17th, 2022. There are 466 total participants needed between 47 different locations."

Answered by AI

Are the individuals in this research project of age?

"This trial includes individuals that fall between 18 and 60 years old."

Answered by AI

To whom does this opportunity to participate in research extend?

"466 patients that currently suffer from renal failure and fall between 18-60 years old can participate in this trial. Furthermore, these individuals must have an APOL1 genotype of G1/G1, G2/G2, or G1/G2 as well as proteinuric kidney disease."

Answered by AI

How many willing participants are enrolled in this experiment?

"That is correct. The clinical trial, posted on March 30th, 2022 and updated October 17th, is currently looking for 466 participants at 47 sites across the country."

Answered by AI

Who else is applying?

What site did they apply to?
AKDHC Medical Research Service LLC - Banner Desert Office
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
NANI Research LLC
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I want to help others. I want to reverse my kidney failure. I want to see if I qualify for the study.
PatientReceived no prior treatments
I want to possible help others and myself.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Phase 2/3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1- Mediated Proteinuric Kidney Disease Mediated Proteinuric Kidney Disease
2022. "Phase 2/3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1- Mediated Proteinuric Kidney Disease Mediated Proteinuric Kidney Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05312879.
All > Kidney Failure
~228 spots leftby May 2026
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