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Completed

NCT Number: NCT05656040

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Velocity Clinical Research, New Smyrna Beach ( Site 0003), Edgewater, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MK-2060

Biological

MK-2060 lyophilized powder diluted in normal saline and administered subcutaneously

Placebo

Drug

Normal saline administered subcutaneously

Primary outcomes

  1. Part 1: Number of Participants Who Experience One or More Bleeding Related Adverse Events (AE)

    Time frame: Up to approximately 104 days

    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.

  2. Part 2: Number of Participants Who Experience One or More Bleeding Related AEs

    Time frame: Up to approximately 144 days

    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.

  3. Part 3: Number of Participants Who Experience One or More Bleeding Related AEs

    Time frame: Up to approximately 104 days

    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.

  4. Part 1: Number of Participants Who Experience One or More AEs

    Time frame: Up to approximately 104 days

    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.

  5. Part 2: Number of Participants Who Experience One or More AEs

    Time frame: Up to approximately 144 days

    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.

  6. Part 3: Number of Participants Who Experience One or More AEs

    Time frame: Up to approximately 104 days

    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.

  7. Part 1: Number of Participants Who Discontinue Study Treatment to an AE

    Time frame: Up to approximately 104 days

    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.

  8. Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: Up to approximately 144 days

    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.

  9. Part 3: Number of Participants Who Discontinue Study Due to an AE

    Time frame: Up to approximately 104 days

    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.

  10. Part 1: Area Under the Concentration-Time Curve From 0 to Infinity (AUC0-inf) of MK-2060

    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

    Blood was collected to determine the AUC0-inf of MK-2060 in plasma.

  11. Part 2: AUC0-inf of MK-2060

    Time frame: 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

    Blood was to be collected at pre-specified time points to determine the AUC0-inf of MK-2060 in plasma.

  12. Part 3: AUC0-inf of MK-2060

    Time frame: 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

    Blood was to be collected at pre-specified time points to determine the AUC0-inf of MK-2060 in plasma.

  13. Part 1: Area Under the Concentration-Time Curve From Time 0 to 168 Hours (AUC0-168) of MK-2060

    Time frame: Pre-dose, 1, 12, 24, 48, 120, and 168 hours post-dose

    Blood was collected to determine the AUC0-168 of MK-2060 in plasma.

  14. Part 2: AUC0-168 of MK-2060

    Time frame: Pre-dose, 24, 72, and 168 hours post-dose

    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.

  15. Part 3: AUC0-168 of MK-2060

    Time frame: Pre-dose, 1, 12, 24, 48, 120, and 168 hours post-dose

    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.

  16. Part 1: Maximum Plasma Concentration (Cmax) of MK-2060

    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

    Blood was collected at pre-specified time points to determine the Cmax of MK-2060 in plasma.

  17. Part 2: Cmax of MK-2060

    Time frame: 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

    Blood was to be collected at pre-specified time points to determine the Cmax of MK-2060 in plasma.

  18. Part 3: Cmax of MK-2060

    Time frame: 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

    Blood was to be collected at pre-specified time points to determine the Cmax of MK-2060 in plasma.

  19. Part 1: Plasma Concentration at 168 Hours (C168) of MK-2060

    Time frame: 168 hours post-dose

    Blood was collected at 168 hours post-dose to determine the C168 of MK-2060 in plasma.

  20. Part 2: C168 of MK-2060

    Time frame: 168 hours post-dose

    Blood was to be collected at 168 hours post-dose to determine the C168 of MK-2060 in plasma.

  21. Part 3: C168 of MK-2060

    Time frame: 168 hours post-dose

    Blood was to be collected at 168 hours post-dose to determine the C168 of MK-2060 in plasma.

  22. Part 1: Time to Maximum Plasma Concentration (Tmax) of MK-2060

    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

    Blood was collected at pre-specified time points to determine the Tmax of MK-2060 in plasma.

  23. Part 2: Tmax of MK-2060

    Time frame: 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

    Blood was to be collected at pre-specified time points to determine the Tmax of MK-2060 in plasma.

  24. Part 3: Tmax of MK-2060

    Time frame: 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

    Blood was to be collected at pre-specified time points to determine the Tmax of MK-2060 in plasma.

  25. Part 1: Terminal Half Life (t1/2) of MK-2060

    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

    Blood was collected at pre-specified time points to determine the terminal t1/2 of MK-2060 in plasma.

  26. Part 2: t1/2 of MK-2060

    Time frame: 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

    Blood was to be collected at pre-specified time points to determine the terminal t1/2 of MK-2060 in plasma.

  27. Part 3: t1/2 of MK-2060

    Time frame: 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

    Blood was to be collected at pre-specified time points to determine the terminal t1/2 of MK-2060 in plasma.

  28. Part 1: Apparent Total Clearance (CL/F) of MK-2060

    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

    Blood was collected at pre-specified time points to determine the CL/F of MK-2060 in plasma.

  29. Part 2: CL/F of MK-2060

    Time frame: 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

    Blood was to be collected at pre-specified time points to determine the CL/F of MK-2060 in plasma.

  30. Part 3: CL/F of MK-2060

    Time frame: 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

    Blood was to be collected at pre-specified time points to determine the CL/F of MK-2060 in plasma.

  31. Part 1: Apparent Volume of Distribution (Vz/F) of MK-2060

    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

    Blood was collected at pre-specified time points to determine the Vz/F of MK-2060 in plasma

  32. Part 2: Vz/F of MK-2060

    Time frame: 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

    Blood was to be collected at pre-specified time points to determine the Vz/F of MK-2060 in plasma

  33. Part 3: Vz/F of MK-2060

    Time frame: 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

    Blood was to be collected at pre-specified time points to determine the Vz/F of MK-2060 in plasma

Secondary outcomes

  1. Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060

    Time frame: Day 1 (1 hr and 12 hrs postdose) and Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and Post Study (Day 90)

    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.

  2. Part 2: Percent Change From Baseline in aPTT of MK-2060

    Time frame: Day 1 (1 hr and 12 hrs postdose) and Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and Post Study (Day 90)

    Blood was to be collected at pre-specified time points to determine the aPTT of MK-2060 in plasma.

  3. Part 3: Percent Change From Baseline in aPTT of MK-2060

    Time frame: Day 1 (1 hr and 12 hrs postdose) and Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and Post Study (Day 90)

    Blood was to be collected at pre-specified time points to determine the aPTT of MK-2060 in plasma.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 19, 2022
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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