MK-1084 for Kidney Failure

Recruiting at 1 trial location

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Disqualifiers: Cancer, HIV, Hepatitis B/C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a new treatment, MK-1084, functions in individuals with kidney problems, specifically those with renal impairment (RI), compared to healthy individuals. The primary goal is to determine how the body processes MK-1084 and assess its safety and tolerability in people with moderate to severe kidney issues. The trial includes three groups: individuals with severe RI, moderate RI, and healthy participants, each receiving a single dose of MK-1084. Suitable candidates have moderate or severe kidney issues but are otherwise healthy, with stable kidney function and no history of dialysis for at least a year. As a Phase 1 trial, this research aims to understand how MK-1084 works in people, offering participants the chance to be among the first to receive this new treatment.

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-1084 is likely to be safe for humans?

Research has shown that MK-1084 has a manageable safety profile based on previous studies. In trials with patients who have certain types of cancer, MK-1084 was generally well-tolerated. Most patients continued with the treatment, and only a few stopped because of side effects. Specifically, about 6% of participants left the study due to unwanted effects from the drug.

This suggests that MK-1084 might be safe for most people. However, since the current study is in an early phase, researchers are still collecting safety data, especially for those with kidney issues. It's important to note that early-phase studies primarily focus on understanding a treatment's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for kidney failure, which often include dialysis or transplantation, MK-1084 presents a novel approach by offering a single oral dose that targets renal impairment directly. Researchers are excited because MK-1084 could potentially simplify the treatment process, making it less invasive and more convenient for patients. This new treatment stands out due to its unique mechanism of action, which targets specific pathways involved in kidney function, offering hope for improved outcomes in patients with varying degrees of renal impairment.

What evidence suggests that MK-1084 might be an effective treatment for kidney failure?

Research has shown that MK-1084 targets a specific change in the KRAS gene, often found in cancers such as advanced colorectal cancer and non-small cell lung cancer. This drug has shown promise in combating these cancers. In this trial, researchers are studying MK-1084 for its potential effects on kidney function. Participants in different arms of the trial, including those with severe renal impairment, moderate renal impairment, and healthy individuals, will receive a single oral dose of MK-1084. Early results appear promising, but further research is needed to confirm its benefits for kidney problems. ^{1 4 6 7 8}

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 stable kidney function who haven't been on dialysis in the past year. It includes those with moderate or severe renal impairment and healthy individuals, provided they have a BMI between 18.0 and 40.0 kg/m2 and are generally healthy apart from their kidney issues.

Inclusion Criteria

All participants must have a BMI ≥18.0 and ≤40.0 kg/m^2

My kidney function is stable, and I haven't been on dialysis in the last year.

I am healthy with normal kidney function.

Exclusion Criteria

I haven't had cancer before, don't have HIV, hepatitis B or C, and haven't had major surgery or lost a lot of blood in the last 56 days.

I have kidney issues but no history of kidney artery narrowing, transplant, or removal.

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 MK-1084 under fasting conditions

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and pharmacokinetics of MK-1084

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MK-1084

Trial Overview The study is examining MK-1084 to see how it's processed by people with different levels of kidney health. It compares how long MK-1084 stays in the bodies of those with renal impairment versus healthy participants, while also assessing its safety and tolerability.

How Is the Trial Designed?

Group I: Panel C: Healthy Experimental Treatment 1 Intervention

Healthy participants will be administered a single oral dose of MK-1084 on Day 1 under fasting conditions.

Group II: Panel B: Moderate RI Experimental Treatment 1 Intervention

Participants with moderate RI will be administered a single oral dose of MK-1084 on Day 1 under fasting conditions.

Group III: Panel A: Severe RI Experimental Treatment 1 Intervention

Participants with severe RI will be administered a single oral dose of MK-1084 on Day 1 under fasting conditions.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

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

1. merck.com merck.com/news/merck-announces-mk-1084-an-investigational-kras-g12c-inhibitor-shows-antitumor-activity-in-phase-1-trial-of-patients-with-advanced-colorectal-cancer-and-non-small-cell-lung-cancer-whose-tumors-harbo/

Merck Announces MK-1084, an Investigational KRAS ... Immune-Mediated Nephritis With Renal Dysfunction. KEYTRUDA can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (9 ...

2. urotoday.com urotoday.com/conference-highlights/asco-2025/asco-2025-press-releases/160724-research-on-novel-treatment-approaches-and-scientific-advances-from-merck-s-broad-and-differentiated-oncology-portfolio-and-pipeline-to-be-presented-at-asco-2025.html

Research on Novel Treatment Approaches and Scientific ... New and updated data for MK-1084, an investigational KRAS G12C inhibitor, from the colorectal cancer and non-small cell lung cancer cohorts of the Phase 1 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11110875/

Safety and efficacy of apixaban versus vitamin K antagonists ... This review aims to evaluate the safety and efficacy of apixaban vs. vitamin K antagonists (VKAs) in patients on dialysis.

4. go.drugbank.com go.drugbank.com/conditions/DBCOND0038927

Impaired Renal Function (DBCOND0038927) A Clinical Study of MK-1084 in Participants With Renal Impairment (MK-1084-010). MK-1084. treatment, 1, recruiting. NCT06723535. A Study to Evaluate BMS-986278 ...

5. finance.yahoo.com finance.yahoo.com/news/merck-announces-mk-1084-investigational-120500314.html

Merck Announces MK-1084, an Investigational KRAS ... Immune-Mediated Nephritis With Renal Dysfunction. KEYTRUDA can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (9 ...

6. withpower.com withpower.com/trial/phase-1-renal-insufficiency-1-2025-92996

MK-1084 for Kidney Failure It compares how long MK-1084 stays in the bodies of those with renal impairment versus healthy participants, while also assessing its safety and tolerability.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05067283

NCT05067283 | A Study of MK-1084 in KRAS Mutant ... This is a study evaluating the safety, pharmacokinetics, and efficacy of MK-1084 alone, and MK-1084 plus other combination therapies in participants with ...

8. onclive.com onclive.com/view/mk-1084-alone-and-plus-pembrolizumab-shows-early-safety-activity-in-kras-g12c-solid-tumors

MK-1084 Alone and Plus Pembrolizumab Shows Early ... At data cutoff, 84% of patients were still receiving treatment and 16% had discontinued due to disease progression (10%) or AEs (6%). Additional ...