MK-2828 for Chronic Kidney Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment, MK-2828 (an experimental treatment), to observe its behavior in individuals with various kidney conditions. The study includes three groups: those with severe kidney issues not on dialysis, those with end-stage kidney disease on dialysis, and healthy individuals for comparison. It suits individuals with stable, long-term kidney problems or end-stage kidney disease who receive regular dialysis treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Is there any evidence suggesting that MK-2828 is likely to be safe for humans?
Research shows that MK-2828 is under study to assess its safety and tolerability. In other studies, researchers closely monitored individuals with various kidney diseases who received MK-2828 for any side effects. Although specific results from these studies are not yet available, MK-2828's presence in early clinical trials indicates ongoing safety evaluations in humans. Consequently, information on side effects or tolerability may be limited at this stage. Prospective participants should discuss any concerns with their doctor.12345
Why do researchers think this study treatment might be promising for chronic kidney disease?
Most treatments for chronic kidney disease, especially for those at the end-stage on hemodialysis, focus on managing symptoms and slowing disease progression often through medications like ACE inhibitors or dialysis itself. However, MK-2828 is unique because it utilizes a novel active ingredient that is administered in single doses, potentially simplifying the treatment regimen. Unlike the standard treatments, which are continuous, MK-2828 is given with at least a 14-day washout period, suggesting a different mechanism or longer-lasting effect. Researchers are excited about MK-2828 because it might offer a new way to address kidney dysfunction directly, possibly improving outcomes for patients with severe renal impairment.
What evidence suggests that MK-2828 might be an effective treatment for chronic kidney disease?
Research is investigating how MK-2828 might assist with kidney disease. This trial will examine MK-2828 in various groups: participants with end-stage renal disease on hemodialysis, those with severe renal impairment, and healthy matched controls. Although limited data exists on its effectiveness for chronic kidney disease, the primary goal is to understand the drug's behavior in the body. This includes examining its absorption, distribution, metabolism, and excretion in individuals with different kidney functions. Early results from similar studies have guided researchers in assessing MK-2828's potential for aiding those with kidney issues. Further research is necessary to confirm its effectiveness in treating the disease.12346
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
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
Participants receive a single dose of MK-2828 on Day 1, with a washout period of at least 14 days between doses for those in the ESRD group
Follow-up
Participants are monitored for pharmacokinetic parameters and adverse events
What Are the Treatments Tested in This Trial?
Interventions
- MK-2828
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Participants with severe renal impairment will receive a single dose of MK-2828 on Day 1
Participants with normal renal function will receive a single dose of MK-2828 on Day 1
Participants with ESRD will receive a single dose of MK-2828 on Day 1 in each of 2 periods, with a washout of at least 14 days between doses.
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
Citations
A Clinical Trial of MK-2828 in People With Kidney Disease ...
The goal of this trial is to measure what happens to 1 or 2 doses of MK-2828 in a person's body over time (pharmacokinetic or PK trial).
A Clinical Trial of MK-2828 in People With Kidney Disease
The goal of this trial is to measure what happens to 1 or 2 doses of MK-2828 in a person's body over time (pharmacokinetic or PK trial).
3.
ctv.veeva.com
ctv.veeva.com/study/a-clinical-trial-of-mk-2828-in-people-with-kidney-disease-mk2828006A Clinical Trial of MK-2828 in People With Kidney Disease ...
The goal of this trial is to measure what happens to 1 or 2 doses of MK-2828 in a person's body over time (pharmacokinetic or PK trial).
Multiple Dose Study of MK-2828 in Participants With Type ...
A phase of research used to describe exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body. They ...
Age and the Association of Kidney Measures with Mortality ...
We analyzed data from 2 million participants in 46 different cohorts to characterize the mortality and end-stage renal disease (ESRD) risk across the full age ...
Inclusion of Participants with CKD and Other Kidney-Related ...
We performed a landscape analysis of anticancer agents approved from 2015 to 2019 to evaluate inclusion of study participants with CKD and GFR assessment ...
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