VX-840 for Kidney Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial focuses on understanding the behavior and safety of a new treatment, VX-840, in the body. Researchers test different doses to assess tolerance levels. Participants will receive either the actual treatment or a placebo (a harmless pill resembling the treatment) in different study phases. The trial seeks healthy individuals with a body mass index (BMI) between 18 and 32 and a body weight over 50 kg. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that VX-840 is likely to be safe for humans?
Research has shown that VX-840 is currently being tested for safety in humans. In earlier studies, researchers administered VX-840 to healthy individuals to assess its safety and tolerability. The treatment was generally well-tolerated, with most participants experiencing no serious side effects. Some common side effects were mild and resolved on their own.
As this study is in its early stages, the primary goal is to ensure VX-840 does not cause harm. The drug is still undergoing careful testing before advancing to more advanced stages. Results so far suggest that VX-840 is safe enough to continue testing, but more information is needed to fully understand its safety profile.12345Why do researchers think this study treatment might be promising?
VX-840 is unique because it represents a novel approach by focusing on safety and pharmacokinetics, which means it looks closely at how the drug moves through the body and at what dose levels it's safe. Unlike current treatments for similar conditions, which might rely on established mechanisms like blocking certain enzymes or receptors, VX-840 could offer a fresh mechanism or method of action. Researchers are excited because new insights into its pharmacokinetics might lead to more precise dosing, potentially improving effectiveness and reducing side effects compared to some existing options.
What evidence suggests that VX-840 could be effective?
Earlier studies have shown that VX-147, a molecule similar to VX-840, reduces proteinuria, a condition where excess protein is present in the urine, in patients with APOL1-related kidney disease. VX-147 blocks the APOL1 protein channel, which is believed to cause kidney damage. In this trial, participants will receive either VX-840 or a placebo. Although researchers are still testing VX-840 for safety and efficacy, it is designed based on VX-147's success. Researchers hope VX-840 may also improve kidney health by targeting the same process. Early findings from similar compounds suggest effectiveness, but further research is needed to confirm this.23456
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part A
Participants receive a single dose of VX-840 or placebo at different dose levels
Treatment Part B
Participants receive multiple doses of VX-840 or placebo at different dose levels, determined based on Part A data
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- VX-840
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Participants will be randomized to receive multiple doses of one of different dose levels of VX-840. The dose levels will be determined based on the data from Part A.
Participants will be randomized to receive single dose of one of different dose levels of VX-840.
Participants will receive placebo matched to VX-840.
Participants will receive placebo matched to VX-840.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vertex Pharmaceuticals Incorporated
Lead Sponsor
Dr. David Altshuler
Vertex Pharmaceuticals Incorporated
Chief Medical Officer since 2020
MD, PhD
Dr. Reshma Kewalramani
Vertex Pharmaceuticals Incorporated
Chief Executive Officer since 2020
MD, trained in internal medicine and nephrology
Published Research Related to This Trial
Citations
APOL1 DIAGNOSTICS AND THERAPEUTICS
Pharmacokinetics (PK) of VX-840 in Healthy Participants. 1. Completed ? Compound inhibitor. NCT05351047. A Study to Assess Safety, Tolerability, PK and PD of.
Novel Therapies in APOL1-Mediated Kidney Disease
A novel small molecule inhibitor on APOL1 channel called VX-147 or inaxaplin demonstrated promising results in reducing proteinuria in patients with APOL1- ...
APOL1 Mediated Kidney Disease: A Review and Look ...
Zhang et al reported that the number of recipient risk variant alleles was associated with an increased risk of death, censored allograft loss, and risk of ...
A Phase 1 Dose Escalation Study to Evaluate Safety and ...
This trial tests a new drug called VX-840 to see if it is safe and well-tolerated in healthy people. The study focuses on safety before using the drug in ...
Real-World Outcomes with Chimeric Antigen Receptor T ...
Effectiveness outcomes of interest were OS, progression-free survival (PFS), overall response rate (ORR), and complete response (CR) rate.
VX-840 - Drug Targets, Indications, Patents
A Phase I, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Pharmacokinetics of Single and Multiple Ascending Doses of VX-840 in ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.