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

Kidney Failure, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05335005
• Other study ID #: 2060-008
• Secondary ID: MK-2060-0082021-
• Status: Completed
• Phase: Phase 1
• Start date: May 30, 2022
• Est. completion date: February 14, 2023

Study information

• Verified date: February 2023
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 14, 2023
• Est. primary completion date: February 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• MK-2060
MK-2060 administered via IV infusion

Locations

Country	Name	City	State
Israel	Hadassah Medical Center-Clinical Reaserch Unit ( Site 0002)	Jerusalem
Romania	ARENSIA Exploratory Medicine-Clinical Nephrology Hospital "Carol Davila" ( Site 0001)	Bucure?ti	Bucuresti
United States	Genesis Clinical Research, LLC ( Site 0003)	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Israel,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to approximately 104 days
Primary	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.	Up to approximately 104 days
Primary	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.	Up to approximately 8 days
Secondary	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.	At protocol specific time points predose and up to 168 hours post-dose
Secondary	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	At protocol specific time points up to 104 days
Secondary	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	168 hours post-dose
Secondary	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	At protocol specific time points up to 104 days
Secondary	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	At protocol specific time points up to 104 days
Secondary	Clearance (CL) of MK-2060	Blood will be collected at pre-specified time points to determine the CL of MK-2060 in plasma	At protocol specific time points up to 104 days
Secondary	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	At protocol specific time points up to 104 days
Secondary	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.	Up to approximately 15 days