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A Study of MK-2060 in Participants With Chronic Kidney Disease (MK-2060-011)

Primary Purpose

End-Stage Renal Disease, End-Stage Kidney Disease, Kidney Failure, Chronic

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MK-2060
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-Stage Renal Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: At the time of screening, has stage 4 chronic kidney disease. 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.

Sites / Locations

  • Velocity Clinical Research, New Smyrna Beach ( Site 0003)Recruiting
  • Genesis Clinical Research, LLC ( Site 0004)Recruiting
  • Alliance for Multispecialty Research, LLC ( Site 0002)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MK-2060

Placebo

Arm Description

MK-2060 administered as a single subcutaneous dose of 30 mg on Day 1

Placebo (normal saline) administered as a single subcutaneous dose on Day 1

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 nonmajor 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 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.
Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of MK-2060
Blood will be collected at pre-specified time points to determine the AUC0-inf of MK-2060 in plasma.
Area Under the Concentration-Time Curve from Time 0 to 168 Hours (AUC0-168) of MK-2060
Blood will be collected at pre-specified time points to determine the AUC0-168 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 at 168 hours post-dose to determine the C168 of MK-2060 in plasma.
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 terminal t1/2 of MK-2060 in plasma.
Apparent Total Clearance (CL/F) of MK-2060
Blood will be collected at pre-specified time points to determine the CL/F of MK-2060 in plasma.
Apparent Volume of Distribution (Vz/F) of MK-2060
Blood will be collected at pre-specified time points to determine the Cmax of MK-2060 in plasma

Secondary Outcome Measures

Percent Change from Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060
Blood will be collected at pre-specified time points to determine the aPTT of MK-2060 in plasma.

Full Information

First Posted
December 9, 2022
Last Updated
October 19, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05656040
Brief Title
A Study of MK-2060 in Participants With Chronic Kidney Disease (MK-2060-011)
Official Title
A Single-Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Subcutaneous MK-2060 in Participants With Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2023 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

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
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single subcutaneous dose of MK-2060 in stage 4 chronic kidney disease (CKD4) participants. The primary hypothesis is 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 is at least 1130 nM*hr.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Renal Disease, End-Stage Kidney Disease, Kidney Failure, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MK-2060
Arm Type
Experimental
Arm Description
MK-2060 administered as a single subcutaneous dose of 30 mg on Day 1
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (normal saline) administered as a single subcutaneous dose on Day 1
Intervention Type
Biological
Intervention Name(s)
MK-2060
Intervention Description
MK-2060 lyophilized powder diluted in normal saline and administered subcutaneously
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Normal saline administered subcutaneously
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 nonmajor 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 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 104 days
Title
Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of MK-2060
Description
Blood will be collected at pre-specified time points to determine the AUC0-inf of MK-2060 in plasma.
Time Frame
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
Title
Area Under the Concentration-Time Curve from Time 0 to 168 Hours (AUC0-168) of MK-2060
Description
Blood will be collected at pre-specified time points to determine the AUC0-168 of MK-2060 in plasma from 0 to 168 hours.
Time Frame
Pre-dose, 1, 12, 24, 48, 120, and 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
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
Title
Plasma Concentration at 168 Hours (C168) of MK-2060
Description
Blood will be collected at 168 hours post-dose to determine the C168 of MK-2060 in plasma.
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
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
Title
Terminal Half Life (t1/2) of MK-2060
Description
Blood will be collected at pre-specified time points to determine the terminal t1/2 of MK-2060 in plasma.
Time Frame
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
Title
Apparent Total Clearance (CL/F) of MK-2060
Description
Blood will be collected at pre-specified time points to determine the CL/F of MK-2060 in plasma.
Time Frame
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
Title
Apparent Volume of Distribution (Vz/F) of MK-2060
Description
Blood will be collected at pre-specified time points to determine the Cmax of MK-2060 in plasma
Time Frame
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
Secondary Outcome Measure Information:
Title
Percent Change from Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060
Description
Blood will be collected at pre-specified time points to determine the aPTT of MK-2060 in plasma.
Time Frame
Baseline and 90 days post-dose

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: At the time of screening, has stage 4 chronic kidney disease. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Velocity Clinical Research, New Smyrna Beach ( Site 0003)
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
386-428-7730
Facility Name
Genesis Clinical Research, LLC ( Site 0004)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
813-755-4403
Facility Name
Alliance for Multispecialty Research, LLC ( Site 0002)
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
865-305-9100

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
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information

Learn more about this trial

A Study of MK-2060 in Participants With Chronic Kidney Disease (MK-2060-011)

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