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Monoclonal Antibody
Anti-Factor XI Monoclonal Antibody for Kidney Failure
Phase 2
Waitlist Available
Research Sponsored by Merck Sharp & Dohme LLC
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 belowSelect...
I am on hemodialysis at least 3 times a week for 3 hours each, through a working graft.
Select...
I have end-stage renal disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 37 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 37 months
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 moreTrial 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 LLCLead Sponsor
3,896 Previous Clinical Trials
5,062,229 Total Patients Enrolled
1 Trials studying Kidney Failure
8 Patients Enrolled for Kidney Failure
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,117 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,782 Previous Clinical Trials
8,065,827 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on hemodialysis at least 3 times a week for 3 hours each, through a working graft.I am taking or will take blood thinners, except for heparin during dialysis and aspirin.I am not pregnant, breastfeeding, and if capable of bearing children, I agree to use contraception during and after the study.I have end-stage renal disease.I have not had recent severe bleeding or a history of frequent bleeding in the past 2 years.I plan to receive a kidney transplant from a living donor within the next year.I have had cancer within the last year, but not including non-melanoma skin cancers.You have a mechanical or prosthetic heart valve.I plan to get an AVF placement within the next year.I have not had a bleeding stroke or a small vessel stroke in the last month.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: MK-2060 High Dose
- Group 3: MK-2060 Low Dose
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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?
DaVita Clinical Research - Columbus ( Site 0532)
AKDHC MEDICAL RESEARCH SERVICES, LLC-Maryvale ( Site 0723)
Elixia Clinical Research Collaborative (CRC) - Southeast Florida ( Site 0728)
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
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