20 Participants NeededMy employer runs this trial

Nemtabrutinib for Kidney Failure

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Overseen ByToll Free Number
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Merck Sharp & Dohme LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

MD

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

All participants have a body mass index (BMI) ≥18.0 and ≤40.0 kg/m^2
My severe kidney problems are stable over time.
Healthy volunteers are medically healthy with no clinically significant medical history

Exclusion Criteria

I do not have any major health problems or diseases in my organs or body systems.
I have kidney problems and no other serious illnesses that could affect the study.
Healthy Matched Control Participants with remote history of uncomplicated medical events may be enrolled at investigator discretion

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of nemtabrutinib on Day 1

1 day
1 visit (in-person)

Follow-up

Participants are monitored for pharmacokinetics and safety, including blood sample collection

2 weeks
Multiple visits for blood sampling

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

Group I: NemtabrutinibExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

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 profile image

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

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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.