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Monoclonal Antibody

Anti-Factor XI Monoclonal Antibody for Kidney Failure

Phase 2
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Receiving hemodialysis (including hemodiafiltration) ≥3 times per week for a minimum of 3 hours per session via a mature normally functioning, uninfected AVG with at least 75% of the sessions meeting these criteria over the 4 weeks prior to randomization
Current diagnosis of ESRD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 37 months
Awards & highlights

Study Summary

This trial is testing whether a drug is effective and safe for people with kidney failure who receive dialysis. The hypothesis is that the drug will help prevent problems with an arteriovenous graft.

Who is the study for?
This trial is for adults with end-stage renal disease (ESRD) who are on hemodialysis through an arteriovenous graft. Participants must not be pregnant, agree to contraception if of childbearing potential, and have had stable dialysis sessions. Exclusions include recent cancer or strokes, recurrent bleeding episodes, substance abuse history, and those on certain blood thinners.Check my eligibility
What is being tested?
The study tests two doses of MK-2060 (an antibody targeting clotting Factor XI) against a placebo in ESRD patients undergoing hemodialysis. The goal is to find the better dose for preventing complications related to the dialysis access point by comparing how long it takes for issues to arise.See study design
What are the potential side effects?
Potential side effects may include bleeding events due to MK-2060's effect on blood clotting processes. Since this medication targets a specific part of the clotting mechanism, there could also be risks associated with immune reactions or infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am on hemodialysis at least 3 times a week for 3 hours each, through a working graft.
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I have end-stage renal disease.
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I am not pregnant, breastfeeding, and if capable of bearing children, I agree to use contraception during and after the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 37 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 37 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Thrombosis
Secondary outcome measures
Hemorrhage
Number of Participants Who Discontinue Study Intervention Due to an AE
Number of Participants who Experience One or More Adverse Events (AEs)
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: MK-2060 Low DoseExperimental Treatment1 Intervention
MK-2060 low dose administered via intravenous (IV) infusion as a loading dose: Every other day (QOD) during week 1 (3 administrations), then once a week (QW) after week 1
Group II: MK-2060 High DoseExperimental Treatment1 Intervention
MK-2060 high dose administered via IV infusion as a loading dose: QOD during week 1 (3 administrations), then QW after week 1
Group III: PlaceboPlacebo Group1 Intervention
Placebo (normal saline) administered via IV infusion as a loading dose: QOD during week 1 (3 administrations), then once a week after week 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MK-2060
2019
Completed Phase 1
~70

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,172 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,847 Previous Clinical Trials
5,045,433 Total Patients Enrolled
1 Trials studying Kidney Failure
8 Patients Enrolled for Kidney Failure
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,758 Previous Clinical Trials
8,058,772 Total Patients Enrolled

Media Library

MK-2060 (Monoclonal Antibody) Clinical Trial Eligibility Overview. Trial Name: NCT05027074 — Phase 2
Kidney Failure Research Study Groups: MK-2060 High Dose, MK-2060 Low Dose, Placebo
Kidney Failure Clinical Trial 2023: MK-2060 Highlights & Side Effects. Trial Name: NCT05027074 — Phase 2
MK-2060 (Monoclonal Antibody) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05027074 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many different facilities are conducting this research at the moment?

"Currently, 77 clinical trial sites are operational for this study. A few examples of these locations include the California Institute Of Renal Research ( Site 0679) in El Centro, Capital District Renal Physicians ( Site 0633) in Albany, and AKDHC MEDICAL RESEARCH SERVICES, LLC-Maryvale ( Site 0723) in Phoenix."

Answered by AI

Can new patients sign up for this treatment program?

"From what is published on clinicaltrials.gov, it appears that this particular clinical trial is still looking for patients to enroll. The first posting was on September 17th, 2021 and the most recent update was on November 3rd, 2022."

Answered by AI

How many test subjects are taking part in this experiment?

"The sponsor, Merck Sharp & Dohme LLC, needs to recruit 489 individuals that meet the study's inclusion criteria in order to move forward. The trial will take place at various locations California Institute Of Renal Research ( Site 0679) and Capital District Renal Physicians ( Site 0633)."

Answered by AI

Could you explain what possible side effects there are to MK-2060?

"While there is some evidence suggesting that MK-2060 is safe, it only received a score of 2 because this is a Phase 2 trial and no data currently supports its efficacy."

Answered by AI

Who else is applying?

What site did they apply to?
Elixia Clinical Research Collaborative (CRC) - Southeast Florida ( Site 0728)
What portion of applicants met pre-screening criteria?
Did not meet criteria
~59 spots leftby Jul 2024