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

NCT05335005 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: 2060-008MK-2060-0082021-005333-17
• Study Type: interventional
• Target: 12
• Locations: 3 countries
• Sites: 3

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.

Conditions

End-Stage Renal Disease; Kidney Failure, Chronic

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Up to approximately 8 days

Secondary Outcomes (8)

• Area Under the Concentration-Time Curve From 0 to 168 Hours (AUC0-168) of MK-2060

  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

  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

  Days 1 and 8: 168 hours post-dose

• Time to Maximum Plasma Concentration (Tmax) of MK-2060

  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

  Day 8: predose, and 1, 12, and 24 hours postdose. Once daily on Days 10, 12, 15, 21, 29, 35, 49, 67, and 104.

Study Arms (1)

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.

Drug: MK-2060

Interventions

MK-2060 DRUG

MK-2060 administered via IV infusion

MK-2060

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (3)

Genesis Clinical Research, LLC ( Site 0003)

Tampa, Florida, 33603, United States

Location

Hadassah Medical Center-Clinical Reaserch Unit ( Site 0002)

Jerusalem, 9112001, Israel

Location

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

Bucharest, București, 010701, Romania

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharpe & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 19, 2022
• Study Start: May 30, 2022
• Primary Completion: February 14, 2023
• Study Completion: February 14, 2023
• Last Updated: October 17, 2024
• Results First Posted: October 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1); IL (1); RO (1)