MK-8527 for Kidney Failure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called MK-8527, an experimental drug, to evaluate its safety and how the body processes it in individuals with varying kidney function levels. Researchers aim to understand the treatment's effects on people with moderate to severe kidney problems compared to those with healthy kidneys. Participants should either have stable but impaired kidney function or be healthy with normal kidney function. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in humans.
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 MK-8527 is likely to be safe for humans?
Research shows that MK-8527 is under study to assess its effects on individuals with varying kidney function levels. In earlier studies, researchers administered MK-8527 to adults, including those with moderate or severe kidney issues, to understand the drug's metabolism and safety.
Results so far suggest that MK-8527 is generally well-tolerated. However, some patients experienced decreased kidney function, indicating reduced kidney performance after taking the drug. Monitoring these changes closely is crucial. If serious kidney problems occur, discontinuing the drug is recommended.
This information comes from early-stage research, which primarily aims to understand the drug's workings in the body and identify potential side effects. As further studies are conducted, researchers will gain a clearer understanding of the drug's safety and its potential benefits for individuals with kidney problems.12345Why do researchers think this study treatment might be promising for kidney failure?
Unlike the standard treatments for kidney failure, which often involve dialysis or kidney transplants, MK-8527 is unique because it offers a new approach by potentially enhancing kidney function with a single dose. Researchers are excited about MK-8527 because it targets different stages of renal impairment, from healthy individuals to those with moderate and severe conditions, in a single treatment arm. This could lead to a more streamlined and efficient treatment option, reducing the need for ongoing and invasive procedures.
What evidence suggests that MK-8527 might be an effective treatment for kidney failure?
Research has primarily focused on MK-8527's effects on HIV, providing some information about its safety and metabolism. Studies have linked MK-8527 to sudden kidney failure when combined with high doses of pain relievers like NSAIDs, particularly in individuals with pre-existing kidney issues. This suggests the drug can significantly impact kidney function. However, no direct evidence yet supports its use in treating kidney failure. The current trial aims to understand how the drug affects individuals with varying kidney health levels. Participants will be divided into groups based on kidney function: healthy individuals, those with moderate renal impairment, and those with severe renal impairment, all receiving a single dose of MK-8527.13567
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
This trial is for adults with moderate to severe kidney failure who are otherwise healthy and have stable kidney function. It includes those with normal renal function matched by age to participants with impaired kidneys.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of MK-8527 on Day 1
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- MK-8527
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University