Nemtabrutinib for Kidney Failure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, nemtabrutinib, to observe its behavior in individuals with severe kidney disease. The researchers aim to compare the drug's effects in these individuals to those in healthy participants. Individuals with stable kidney function despite long-term kidney failure, as well as completely healthy individuals, might qualify for participation. This research holds significance for potentially providing new treatments for those with serious kidney issues. As a Phase 1 trial, it focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new drug.
Is there any evidence suggesting that nemtabrutinib is likely to be safe for humans?
Research has shown that nemtabrutinib underwent testing in earlier studies to assess its safety. The results indicated that most patients tolerated the treatment well. Some reported side effects included sudden kidney problems and heart-related issues, but these were manageable and did not raise unexpected safety concerns.
It is important to remember that the safety of nemtabrutinib remains under investigation, particularly in individuals with serious kidney problems. As this trial is in an early stage, it aims to understand how the treatment works in the body, with a strong focus on safety. Researchers are closely monitoring for any potential side effects.12345Why do researchers think this study treatment might be promising?
Nemtabrutinib is unique because it offers a new approach to treating kidney failure by targeting specific pathways in the body that current treatments don't address. Unlike traditional treatments that often focus on managing symptoms or the complications of kidney failure, nemtabrutinib works by directly altering the underlying cellular mechanisms, potentially halting or even reversing damage. Researchers are excited about this treatment because it uses a novel mechanism of action, which could lead to more effective and faster results compared to the existing options.
What evidence suggests that nemtabrutinib might be an effective treatment for kidney failure?
Research has shown that nemtabrutinib yields promising results for other health issues. Studies have found it can help with autoimmune diseases and kidney problems like IgA nephropathy. Nemtabrutinib blocks a protein called Bruton's tyrosine kinase, which plays a role in these diseases, leading to better outcomes in various conditions. Although limited data exists on its effectiveness for severe kidney disease, these findings suggest potential benefits. In this trial, all participants will receive a single oral dose of nemtabrutinib on Day 1 to evaluate its potential benefits for kidney failure.678910
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 severe kidney disease who have stable kidney function, as well as healthy people. Participants must have a BMI between 18 and 40 and be generally healthy without serious medical issues.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 oral dose of nemtabrutinib on Day 1
Follow-up
Participants are monitored for pharmacokinetics and safety, including blood sample collection
What Are the Treatments Tested in This Trial?
Interventions
- Nemtabrutinib
Trial Overview
The study is testing how the drug nemtabrutinib behaves in the body when given to people with severe kidney problems compared to healthy individuals. All participants receive nemtabrutinib.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All participants will receive a single oral dose of nemtabrutinib on Day 1.
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
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demonstrated significant therapeutic/clinical efficacy in autoimmune, IgA nephropathy, multiple sclerosis, and chronic spontaneous urticaria. improved outcomes ...
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Early use improves effectiveness. Kidney Failure, Chronic/complications. Clinical Trial of Nemtabrutinib in Participants With Severe Kidney ...
Brian E. Schwartz
Latest papers. ScopusArticle. First-in-Human Study of the Reversible BTK Inhibitor Nemtabrutinib in Patients ... acute renal failure, and one acute coronary ...
Merck Data at the ASH 2024 Annual Meeting Highlights ...
All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Immune-Mediated Nephritis With Renal Dysfunction. KEYTRUDA can ...
Orlando, FL Paid Clinical Trials - Policy Lab
A Study of Nemtabrutinib in Participants With Moderate Hepatic Impairment (MK-1026-015) ... A Clinical Study of MK-1084 in Participants With Renal Impairment (MK- ...
March 2025
... patients included in early-phase oncology clinical trials: Results ... 89P Evaluation of exclusion criteria based on renal function in early-phase ...
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• Renal and Hepatic Impairment: Treatment with REZUROCK has not been studied in patients with pre-existing severe renal or hepatic impairment.
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