A Study of MK-2060 in Participants With Chronic and/or End-Stage Kidney Disease (MK-2060-011)

A Single-and Multiple Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Subcutaneous MK-2060 in Participants With Chronic and/or End-Stage Kidney Disease

This was intended as a three-part study of MK-2060 in participants with chronic and/or end-stage kidney disease (Parts 2 and 3 were not initiated due to reasons not related to safety). The purpose of Part 1 of the study was to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single subcutaneous dose of MK-2060 in stage 4 chronic kidney disease (CKD4) [Part2 was intended to evaluate multiple subcutaneous doses in CKD4 participants and Part 3 was intended to evaluate a single subcutaneous dose of MK-2060 in participants with end-stage kidney disease (ESRD)]. The primary hypothesis for Part 1 was that the true geometric mean of the area under the concentration-time curve from 0 to infinity (AUC0-inf) after a single-dose of MK-2060 in adult CKD4 participants would be at least 11300 nM*hr.

Study Overview

• Status: Completed
• Conditions: Kidney Failure, Chronic; End-Stage Renal Disease; End-Stage Kidney Disease
• Intervention / Treatment: Biological: MK-2060; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Edgewater, Florida, United States, 32132
      • Velocity Clinical Research, New Smyrna Beach ( Site 0003)
    • Miami, Florida, United States, 33147
      • Advanced Pharma CR, LLC ( Site 0006)
    • Tampa, Florida, United States, 33603
      • Genesis Clinical Research, LLC ( Site 0004)
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Alliance for Multispecialty Research, LLC ( Site 0002)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• At the time of screening, has stage 4 or 5 chronic kidney disease (Parts 1 and 2) or end-state kidney disease on peritoneal dialysis (Part 3).
• Has a body mass index (BMI) ≥ 18 and ≤ 45 kg/m^2.

Exclusion Criteria:

• Has a history of cancer, including adenocarcinoma, except adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix or other malignances which have been successfully treated ≥ 5 years prior to prestudy with appropriate follow-up.
• Has a history of deep vein thrombosis or pulmonary embolism, a history of vascular access thrombosis within 1 month prior to enrollment, or has a personal or family history of bleeding disorder.
• Has a history of gastrointestinal (GI) bleeding, duodenal polyps, or gastric ulcer in the last 5 years or severe hemorrhoidal bleed in the last 3 months.
• Has a history of or current frequent epistaxis within the last 3 months or active gingivitis.
• Has ongoing anticoagulant therapy or antiplatelet therapy. Aspirin is permitted.
• Has planned significant dental procedures at the time of screening or pre-dose or other planned surgical procedures within duration of participation of study.
• Is positive for hepatitis B surface antigen or human immunodeficiency virus (HIV).
• Has had major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the pre-study visit.
• Has a history (participant recall) of receiving any human immunoglobulin preparation such as intravenous immunoglobulin (IVIG) or RhoGAM within the last year.
• Has a history (participant recall) of receiving any biological therapy (including human blood products or monoclonal antibodies; excluding erythropoietin and insulin) within the last 3 months or vaccination within the last 1 month, except the seasonal flu and pneumococcal vaccine or COVID-19 vaccine.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MK-2060 30 mg; Participants received MK-2060 30 mg administered as a single subcutaneous dose on Day 1.	Biological: MK-2060; MK-2060 lyophilized powder diluted in normal saline and administered subcutaneously
Placebo Comparator: Placebo; Participants received placebo (normal saline) administered as a single subcutaneous dose on Day 1.	Drug: Placebo; Normal saline administered subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: 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 nonmajor bleeding or major bleeding.	Up to approximately 104 days
Part 2: Number of Participants Who Experience One or More Bleeding Related AEs	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 nonmajor bleeding or major bleeding.	Up to approximately 144 days
Part 3: Number of Participants Who Experience One or More Bleeding Related AEs	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 nonmajor bleeding or major bleeding.	Up to approximately 104 days
Part 1: 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
Part 2: 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 144 days
Part 3: 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
Part 1: Number of Participants Who Discontinue Study Treatment 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 104 days
Part 2: Number of Participants Who Discontinue Study Treatment 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 144 days
Part 3: Number of Participants Who Discontinue Study 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 104 days
Part 1: Area Under the Concentration-Time Curve From 0 to Infinity (AUC0-inf) of MK-2060	Blood was collected to determine the AUC0-inf of MK-2060 in plasma.	Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and 90 post-dose
Part 2: AUC0-inf of MK-2060	Blood was to be collected at pre-specified time points to determine the AUC0-inf of MK-2060 in plasma.	Days 1, 2, 4, 8, 15, and 22: pre-dose; once daily on Days 10, 17, 26, 29, 35, 42, 49, 63, 81, 111, and 130 post-dose
Part 3: AUC0-inf of MK-2060	Blood was to be collected at pre-specified time points to determine the AUC0-inf of MK-2060 in plasma.	Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 42, 60, 90, and 120 post-dose
Part 1: Area Under the Concentration-Time Curve From Time 0 to 168 Hours (AUC0-168) of MK-2060	Blood was collected to determine the AUC0-168 of MK-2060 in plasma.	Pre-dose, 1, 12, 24, 48, 120, and 168 hours post-dose
Part 2: AUC0-168 of MK-2060	Blood was to be collected at pre-specified time points to determine the AUC0-168 of MK-2060 in plasma from 0 to 168 hours.	Pre-dose, 24, 72, and 168 hours post-dose
Part 3: AUC0-168 of MK-2060	Blood was to be collected at pre-specified time points to determine the AUC0-168 of MK-2060 in plasma from 0 to 168 hours.	Pre-dose, 1, 12, 24, 48, 120, and 168 hours post-dose
Part 1: Maximum Plasma Concentration (Cmax) of MK-2060	Blood was collected at pre-specified time points to determine the Cmax of MK-2060 in plasma.	Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and 90 post-dose
Part 2: Cmax of MK-2060	Blood was to be collected at pre-specified time points to determine the Cmax of MK-2060 in plasma.	Days 1, 2, 4, 8, 15, and 22: pre-dose; once daily on Days 10, 17, 26, 29, 35, 42, 49, 63, 81, 111, and 130 post-dose
Part 3: Cmax of MK-2060	Blood was to be collected at pre-specified time points to determine the Cmax of MK-2060 in plasma.	Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 42, 60, 90, and 120 post-dose
Part 1: Plasma Concentration at 168 Hours (C168) of MK-2060	Blood was collected at 168 hours post-dose to determine the C168 of MK-2060 in plasma.	168 hours post-dose
Part 2: C168 of MK-2060	Blood was to be collected at 168 hours post-dose to determine the C168 of MK-2060 in plasma.	168 hours post-dose
Part 3: C168 of MK-2060	Blood was to be collected at 168 hours post-dose to determine the C168 of MK-2060 in plasma.	168 hours post-dose
Part 1: Time to Maximum Plasma Concentration (Tmax) of MK-2060	Blood was collected at pre-specified time points to determine the Tmax of MK-2060 in plasma.	Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and 90 post-dose
Part 2: Tmax of MK-2060	Blood was to be collected at pre-specified time points to determine the Tmax of MK-2060 in plasma.	Days 1, 2, 4, 8, 15, and 22: pre-dose; once daily on Days 10, 17, 26, 29, 35, 42, 49, 63, 81, 111, and 130 post-dose
Part 3: Tmax of MK-2060	Blood was to be collected at pre-specified time points to determine the Tmax of MK-2060 in plasma.	Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 42, 60, 90, and 120 post-dose
Part 1: Terminal Half Life (t1/2) of MK-2060	Blood was collected at pre-specified time points to determine the terminal t1/2 of MK-2060 in plasma.	Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and 90 post-dose
Part 2: t1/2 of MK-2060	Blood was to be collected at pre-specified time points to determine the terminal t1/2 of MK-2060 in plasma.	Days 1, 2, 4, 8, 15, and 22: pre-dose; once daily on Days 10, 17, 26, 29, 35, 42, 49, 63, 81, 111, and 130 post-dose
Part 3: t1/2 of MK-2060	Blood was to be collected at pre-specified time points to determine the terminal t1/2 of MK-2060 in plasma.	Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 42, 60, 90, and 120 post-dose
Part 1: Apparent Total Clearance (CL/F) of MK-2060	Blood was collected at pre-specified time points to determine the CL/F of MK-2060 in plasma.	Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and 90 post-dose
Part 2: CL/F of MK-2060	Blood was to be collected at pre-specified time points to determine the CL/F of MK-2060 in plasma.	Days 1, 2, 4, 8, 15, and 22: pre-dose; once daily on Days 10, 17, 26, 29, 35, 42, 49, 63, 81, 111, and 130 post-dose
Part 3: CL/F of MK-2060	Blood was to be collected at pre-specified time points to determine the CL/F of MK-2060 in plasma.	Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 42, 60, 90, and 120 post-dose
Part 1: Apparent Volume of Distribution (Vz/F) of MK-2060	Blood was collected at pre-specified time points to determine the Vz/F of MK-2060 in plasma	Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and 90 post-dose
Part 2: Vz/F of MK-2060	Blood was to be collected at pre-specified time points to determine the Vz/F of MK-2060 in plasma	Days 1, 2, 4, 8, 15, and 22: pre-dose; once daily on Days 10, 17, 26, 29, 35, 42, 49, 63, 81, 111, and 130 post-dose
Part 3: Vz/F of MK-2060	Blood was to be collected at pre-specified time points to determine the Vz/F of MK-2060 in plasma	Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 42, 60, 90, and 120 post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060	Blood was collected at pre-specified time points to determine the aPTT of MK-2060 in plasma. Positive and negative scores indicate increases and decreases, respectively, in aPTT compared to baseline.	Day 1 (1 hr and 12 hrs postdose) and Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and Post Study (Day 90)
Part 2: Percent Change From Baseline in aPTT of MK-2060	Blood was to be collected at pre-specified time points to determine the aPTT of MK-2060 in plasma.	Day 1 (1 hr and 12 hrs postdose) and Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and Post Study (Day 90)
Part 3: Percent Change From Baseline in aPTT of MK-2060	Blood was to be collected at pre-specified time points to determine the aPTT of MK-2060 in plasma.	Day 1 (1 hr and 12 hrs postdose) and Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and Post Study (Day 90)

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2023
• Primary Completion (Actual): August 12, 2024
• Study Completion (Actual): August 12, 2024

Study Registration Dates

• First Submitted: December 9, 2022
• First Submitted That Met QC Criteria: December 9, 2022
• First Posted (Actual): December 19, 2022

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Pathological Conditions, Signs and Symptoms; Kidney Failure, Chronic; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: 2060-011; MK-2060-011 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No