End-Stage Renal DiseasePhase 1NCT05335005

MK-2060 and Clopidogrel Co-administration Safety and Tolerability Study in Participants With End-Stage Renal Disease (ESRD) (MK-2060-008)

A Phase 1 study testing MK-2060 in people with End-Stage Renal Disease and Kidney Failure, Chronic, run by Merck Sharp & Dohme LLC at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

MK-2060 is being developed for prevention of thrombotic complications in end-stage renal disease (ESRD). The purpose of this study is to conduct a preliminary evaluation of the safety and tolerability of MK-2060 treatment in combination with a commonly used P2Y12 receptor inhibitor, clopidogrel, in ESRD patients. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: End-Stage Renal Disease, Kidney Failure, Chronic
What is being tested?: MK-2060
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 3 sitesin 3 countries
Study dates: 30 May 2022to 14 Feb 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Has End-Stage Renal Disease (ESRD) maintained on stable outpatient hemodialysis (HD) regimen at a healthcare center for > 3 months prior to dosing.
On HD regimen at least 3 times per week for a minimum of 3 hours per dialysis session, using a complication-free well-maintained AV fistula or AV graft.
Is taking clopidogrel for a minimum of 2 weeks prior to the first dosing of MK-2060 administration.
Has a Body Mass Index (BMI) ≥ 18 and ≤ 45 kg/m^2.

Who cannot join

History of cancer (malignancy), including adenocarcinoma, except adequately treated nonmelanomatous skin carcinoma or carcinoma in situ of the cervix or other malignancies that have been successfully treated with appropriate follow up.
Has a history of deep vein thrombosis or pulmonary embolism.
Has a history of gastrointestinal (GI) bleeding, duodenal polyps or gastric ulcer in the last 5 years or severe hemorrhoidal bleed in last 3 months prior to screening.
Is positive for hepatitis B surface antigen or human immunodeficiency virus (HIV).
Has ongoing anticoagulant therapy or antiplatelet therapy, not including clopidogrel. Intradialytic heparin is permitted.

Trial locations and contacts

3 sites in 3 countries.

Country

City, postcode or hospital

3 sites in 3 countries

United States1 site

Genesis Clinical Research, LLC ( Site 0003)
Tampa, Florida, 33603

Other trials in United States

Israel1 site

Hadassah Medical Center-Clinical Reaserch Unit ( Site 0002)
Jerusalem, 9112001

Other trials in Israel

Romania1 site

ARENSIA Exploratory Medicine-Clinical Nephrology Hospital "Carol Davila" ( Site 0001)
Bucharest, Bucharest, 010701

Other trials in Romania

About this study

Official title: A Study to Evaluate Safety and Tolerability of Co-administration of MK-2060 and Clopidogrel in Participants With End-Stage Renal Disease on Hemodialysis

Conditions: End-Stage Renal Disease, Kidney Failure, Chronic
Being tested: MK-2060
Medical subject headings: Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MK-2060Drug
MK-2060 administered via IV infusion

Study groups in NCT05335005
Study group	Role	What they receive
MK-2060	Experimental	Participants continued their established background therapy of daily 75 mg clopidogrel for 2 weeks (days -14 to 0). Participants then continued background therapy while receiving 25 mg MK-2060 intravenous (IV) infusion on days 1, 3, 5, and 8. Receives: Drug: MK-2060

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Experience One or More Bleeding Related Adverse Events (AE)
Bleeding related AEs include any sign or symptom of bleeding, even if not requiring intervention by a medical/healthcare professional, as well as clinically-relevant non major bleeding or major bleeding.
Measured: Up to approximately 104 days
Number of Participants Who Experience One or More AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Measured: Up to approximately 104 days
Number of Participants Who Discontinue Study Intervention Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Measured: Up to approximately 8 days

Secondary outcomes (8)

Area Under the Concentration-Time Curve From 0 to 168 Hours (AUC0-168) of MK-2060
The AUC0-168 was defined as the area under the concentration-time curve of MK-2060 in plasma from time zero to 168 hours after administration. The Week 1 value is the extrapolated value using data up to 48 hours postdose Day 1, with the "Partial area" option in WinNonlin software using a Start time of 0 hours and an End time of 168 hours. Week 2 value included data for Day 8: predose, and 1, 12, 24, 48, 96, and 168 hours postdose.
Measured: Day 1: predose, and 1, 12, 24, and 48 hours postdose. Day 8: predose, and 1, 12, 24, 48, 96, and 168 hours postdose.
Maximum Plasma Concentration (Cmax) of MK-2060
Cmax was defined as the maximum concentration of MK-2060 observed in plasma after administration. Week 2 value included data for Day 8: predose and 1, 12, 24, 48, 96, and 168 hours postdose.
Measured: Day 1: predose, and 1, 12, and 48 hours postdose. Day 8: predose, and 1, 12, and 24 hours postdose; and once daily on Days 10, 12, 15, 21, 29, 35, 49, 67, and 104.
Plasma Concentration at 168 Hours (C168) of MK-2060
C168 was defined as the concentration of MK-2060 observed in plasma 168 hours after administration. Week 2 value included data for Day 8: 168 hours postdose.
Measured: Days 1 and 8: 168 hours post-dose
Time to Maximum Plasma Concentration (Tmax) of MK-2060
Tmax was defined as the time required to reach the maximum concentration of MK-2060 observed in plasma after administration. Week 2 value included data for Day 8: predose and 1, 12, 24, 48, 96, and 168 hours postdose.
Measured: Day 1: predose, and 1, 12, and 48 hours postdose. Day 8: predose, and 1, 12, and 24 hours postdose; and once daily on Days 10, 12, 15, 21, 29, 35, 49, 67, and 104.
Terminal Half Life (t1/2) of MK-2060
T1/2 was defined as the time required to divide the MK-2060 plasma concentration by two after reaching pseudo-equilibrium.
Measured: Day 8: predose, and 1, 12, and 24 hours postdose. Once daily on Days 10, 12, 15, 21, 29, 35, 49, 67, and 104.
Clearance at Steady State (CLss) of MK-2060
CLss was defined as the volume of plasma from which MK-2060 was eliminated per unit time following administration, once at steady state.
Measured: Day 8: predose, and 1, 12, and 24 hours postdose. Once daily on Days 10, 12, 15, 21, 29, 35, 49, 67, and 104.
Apparent Volume of Distribution at Steady State (Vss) of MK-2060
Vss was defined as the volume of plasma that would be necessary to contain the total amount of administered MK-2060 at the same concentration that MK-2060 was observed in the blood plasma after reaching steady state.
Measured: Day 8: predose, and 1, 12, and 24 hours postdose. Once daily on Days 10, 12, 15, 21, 29, 35, 49, 67, and 104.
Time to Hemostasis Following MK-2060 Treatment
Time to hemostasis is assessed by measuring the time that pressure is held from removal of dialysis catheters from the dialysis access site [i.e., arteriovenous (AV) fistula or AV graft] until adequate hemostasis has been obtained for both the arterial and venous sites.
Measured: Up to approximately 15 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 May 202214 Feb 2023

First posted19 Apr 2022
Study start30 May 2022
Primary completion14 Feb 2023
Study completion14 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for End-Stage Renal DiseaseStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05335005
Sponsor's protocol ID: 2060-008
Other IDs: MK-2060-008, 2021-005333-17
Status last verified: Jul 2024
First submitted: 12 Apr 2022
Last updated: 17 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult

All End-Stage Renal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate Safety and Tolerability of Co-administration of MK-2060 and Clopidogrel in Participants With End-Stage Renal Disease on Hemodialysis
ClinicalTrials.gov ID: NCT05335005
Acronym / sponsor ID: 2060-008
Conditions: End-Stage Renal Disease, Kidney Failure, Chronic
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 30 May 2022 (actual)
Primary completion: 14 Feb 2023 (actual)
Study completion: 14 Feb 2023 (actual)
First posted: 19 Apr 2022 (actual)
Results: Posted 17 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
MK-2060	Experimental	Drug: MK-2060Participants continued their established background therapy of daily 75 mg clopidogrel for 2 weeks (days -14 to 0). Participants then continued background therapy while receiving 25 mg MK-2060 intravenous (IV) infusion on days 1, 3, 5, and 8.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Has End-Stage Renal Disease (ESRD) maintained on stable outpatient hemodialysis (HD) regimen at a healthcare center for > 3 months prior to dosing.
On HD regimen at least 3 times per week for a minimum of 3 hours per dialysis session, using a complication-free well-maintained AV fistula or AV graft.
Is taking clopidogrel for a minimum of 2 weeks prior to the first dosing of MK-2060 administration.
Has a Body Mass Index (BMI) ≥ 18 and ≤ 45 kg/m^2.

Key exclusion criteria (5 listed)

History of cancer (malignancy), including adenocarcinoma, except adequately treated nonmelanomatous skin carcinoma or carcinoma in situ of the cervix or other malignancies that have been successfully treated with appropriate follow up.
Has a history of deep vein thrombosis or pulmonary embolism.
Has a history of gastrointestinal (GI) bleeding, duodenal polyps or gastric ulcer in the last 5 years or severe hemorrhoidal bleed in last 3 months prior to screening.
Is positive for hepatitis B surface antigen or human immunodeficiency virus (HIV).
Has ongoing anticoagulant therapy or antiplatelet therapy, not including clopidogrel. Intradialytic heparin is permitted.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MK-2060MK-2060 administered via IV infusion	Drug	MK-2060

Primary outcome

Number of Participants Who Experience One or More Bleeding Related Adverse Events (AE)
Time frame: Up to approximately 104 days
Bleeding related AEs include any sign or symptom of bleeding, even if not requiring intervention by a medical/healthcare professional, as well as clinically-relevant non major bleeding or major bleeding.
Number of Participants Who Experience One or More AEs
Time frame: Up to approximately 104 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Number of Participants Who Discontinue Study Intervention Due to an AE
Time frame: Up to approximately 8 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

8 secondary outcomes

Area Under the Concentration-Time Curve From 0 to 168 Hours (AUC0-168) of MK-2060
Time frame: Day 1: predose, and 1, 12, 24, and 48 hours postdose. Day 8: predose, and 1, 12, 24, 48, 96, and 168 hours postdose.
Maximum Plasma Concentration (Cmax) of MK-2060
Time frame: Day 1: predose, and 1, 12, and 48 hours postdose. Day 8: predose, and 1, 12, and 24 hours postdose; and once daily on Days 10, 12, 15, 21, 29, 35, 49, 67, and 104.
Plasma Concentration at 168 Hours (C168) of MK-2060
Time frame: Days 1 and 8: 168 hours post-dose
Time to Maximum Plasma Concentration (Tmax) of MK-2060
Time frame: Day 1: predose, and 1, 12, and 48 hours postdose. Day 8: predose, and 1, 12, and 24 hours postdose; and once daily on Days 10, 12, 15, 21, 29, 35, 49, 67, and 104.
Terminal Half Life (t1/2) of MK-2060
Time frame: Day 8: predose, and 1, 12, and 24 hours postdose. Once daily on Days 10, 12, 15, 21, 29, 35, 49, 67, and 104.
Clearance at Steady State (CLss) of MK-2060
Time frame: Day 8: predose, and 1, 12, and 24 hours postdose. Once daily on Days 10, 12, 15, 21, 29, 35, 49, 67, and 104.
Apparent Volume of Distribution at Steady State (Vss) of MK-2060
Time frame: Day 8: predose, and 1, 12, and 24 hours postdose. Once daily on Days 10, 12, 15, 21, 29, 35, 49, 67, and 104.
Time to Hemostasis Following MK-2060 Treatment
Time frame: Up to approximately 15 days

Results and safety

Results posted to the registry on 17 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MK-2060	12	11

Primary outcome: Number of Participants Who Experience One or More Bleeding Related Adverse Events (AE)

Time frame: Up to approximately 104 days. Count of participants. Unit: Participants

Measure	MK-2060 n = 12
Value	0

Population analysed: The analysis population included all participants who received ≥1 dose of MK-2060.

Primary outcome: Number of Participants Who Experience One or More AEs

Time frame: Up to approximately 104 days. Count of participants. Unit: Participants

Measure	MK-2060 n = 12
Value	6

Population analysed: The analysis population included all participants who received ≥1 dose of MK-2060.

Primary outcome: Number of Participants Who Discontinue Study Intervention Due to an AE

Time frame: Up to approximately 8 days. Count of participants. Unit: Participants

Measure	MK-2060 n = 12
Value	0

Population analysed: The analysis population included all participants who received ≥1 dose of MK-2060.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Run-in (Clopidogrel 75 mg) arm: Approximately 14 days MK-2060 25 mg IV/Clopidogrel 75 mg arm: Up to approximately 108 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Run-in (Clopidogrel 75 mg)	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12
MK-2060 25 mg IV/Clopidogrel 75 mg	3 of 12 (25%)	5 of 12 (41.7%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Merck Clinical Trials InformationLink provided by the sponsor.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Related trials for End-Stage Renal Disease

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharpe & Dohme LLC

3 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MK-2060 in people with End-Stage Renal Disease and Kidney Failure, Chronic, run by Merck Sharp & Dohme LLC at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Israel, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experience One or More Bleeding Related Adverse Events (AE) (time frame: Up to approximately 104 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05335005.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.