Back to resultsMK-2060 and Clopidogrel Co-administration Safety and Tolerability Study in Participants With End-Stage Renal Disease (ESRD) (MK-2060-008)
Primary Purpose
End-Stage Renal Disease, Kidney Failure, Chronic
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
MK-2060
Sponsored by
About this trial
This is an interventional treatment trial for End-Stage Renal Disease
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Genesis Clinical Research, LLC ( Site 0003)
- Hadassah Medical Center-Clinical Reaserch Unit ( Site 0002)
- ARENSIA Exploratory Medicine-Clinical Nephrology Hospital "Carol Davila" ( Site 0001)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MK-2060
Arm Description
MK-2060 administered via intravenous (IV) infusion on days 1, 3, and 5 during the first week and on day 8 during the second week.
Outcomes
Primary Outcome Measures
Number of Participants who Experience One or More Bleeding Related Adverse Events (AE)
Bleeding related AEs will 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
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
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.
Secondary Outcome Measures
Area Under the Concentration-Time Curve from 0 to 168 Hours (AUC0-168) of MK-2060
Blood will be collected at pre-specified time points to determine the AUC of MK-2060 in plasma from 0 to 168 hours.
Maximum plasma concentration (Cmax) of MK-2060
Blood will be collected at pre-specified time points to determine the Cmax of MK-2060 in plasma
Plasma concentration at 168 Hours (C168) of MK-2060
Blood will be collected 168 hours post-dose to determine the plasma concentration of MK-2060
Time to Maximum Plasma Concentration (Tmax) of MK-2060
Blood will be collected at pre-specified time points to determine the Tmax of MK-2060 in plasma
Terminal Half Life (t1/2) of MK-2060
Blood will be collected at pre-specified time points to determine the t1/2 of MK-2060 in plasma
Clearance (CL) of MK-2060
Blood will be collected at pre-specified time points to determine the CL of MK-2060 in plasma
Volume of Distribution (Vz) of MK-2060
Blood will be collected at pre-specified time points to determine the Vz of MK-2060 in plasma
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.
Full Information
NCT ID
NCT05335005
First Posted
April 12, 2022
Last Updated
February 18, 2023
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT05335005
Brief Title
MK-2060 and Clopidogrel Co-administration Safety and Tolerability Study in Participants With End-Stage Renal Disease (ESRD) (MK-2060-008)
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 30, 2022 (Actual)
Primary Completion Date
February 14, 2023 (Actual)
Study Completion Date
February 14, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Renal Disease, Kidney Failure, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MK-2060
Arm Type
Experimental
Arm Description
MK-2060 administered via intravenous (IV) infusion on days 1, 3, and 5 during the first week and on day 8 during the second week.
Intervention Type
Drug
Intervention Name(s)
MK-2060
Intervention Description
MK-2060 administered via IV infusion
Primary Outcome Measure Information:
Title
Number of Participants who Experience One or More Bleeding Related Adverse Events (AE)
Description
Bleeding related AEs will 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.
Time Frame
Up to approximately 104 days
Title
Number of Participants who Experience One or More AEs
Description
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.
Time Frame
Up to approximately 104 days
Title
Number of Participants who Discontinue Study Intervention Due to an AE
Description
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.
Time Frame
Up to approximately 8 days
Secondary Outcome Measure Information:
Title
Area Under the Concentration-Time Curve from 0 to 168 Hours (AUC0-168) of MK-2060
Description
Blood will be collected at pre-specified time points to determine the AUC of MK-2060 in plasma from 0 to 168 hours.
Time Frame
At protocol specific time points predose and up to 168 hours post-dose
Title
Maximum plasma concentration (Cmax) of MK-2060
Description
Blood will be collected at pre-specified time points to determine the Cmax of MK-2060 in plasma
Time Frame
At protocol specific time points up to 104 days
Title
Plasma concentration at 168 Hours (C168) of MK-2060
Description
Blood will be collected 168 hours post-dose to determine the plasma concentration of MK-2060
Time Frame
168 hours post-dose
Title
Time to Maximum Plasma Concentration (Tmax) of MK-2060
Description
Blood will be collected at pre-specified time points to determine the Tmax of MK-2060 in plasma
Time Frame
At protocol specific time points up to 104 days
Title
Terminal Half Life (t1/2) of MK-2060
Description
Blood will be collected at pre-specified time points to determine the t1/2 of MK-2060 in plasma
Time Frame
At protocol specific time points up to 104 days
Title
Clearance (CL) of MK-2060
Description
Blood will be collected at pre-specified time points to determine the CL of MK-2060 in plasma
Time Frame
At protocol specific time points up to 104 days
Title
Volume of Distribution (Vz) of MK-2060
Description
Blood will be collected at pre-specified time points to determine the Vz of MK-2060 in plasma
Time Frame
At protocol specific time points up to 104 days
Title
Time to Hemostasis Following MK-2060 Treatment
Description
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.
Time Frame
Up to approximately 15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharpe & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Genesis Clinical Research, LLC ( Site 0003)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Hadassah Medical Center-Clinical Reaserch Unit ( Site 0002)
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
ARENSIA Exploratory Medicine-Clinical Nephrology Hospital "Carol Davila" ( Site 0001)
City
București
State/Province
Bucuresti
ZIP/Postal Code
010701
Country
Romania
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Learn more about this trial
MK-2060 and Clopidogrel Co-administration Safety and Tolerability Study in Participants With End-Stage Renal Disease (ESRD) (MK-2060-008)
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