Phase 1 N=14 Randomized Single-blind Treatment

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

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

Bottom Line

View on ClinicalTrials.gov: NCT05656040 ↗

Enrolled (actual)

Serious AEs

14.3%

Results posted

Sep 2025

Primary outcome: Primary: Part 1: Number of Participants Who Experience One or More Bleeding Related Adverse Events (AE) — 0; 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: MK-2060 (Biological); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Aug 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Part 1: Number of Participants Who Experience One or More Bleeding Related Adverse Events (AE)	0; 0	—
PRIMARY Part 2: Number of Participants Who Experience One or More Bleeding Related AEs	—	—
PRIMARY Part 3: Number of Participants Who Experience One or More Bleeding Related AEs	—	—
PRIMARY Part 1: Number of Participants Who Experience One or More AEs	5; 2	—
PRIMARY Part 2: Number of Participants Who Experience One or More AEs	—	—
PRIMARY Part 3: Number of Participants Who Experience One or More AEs	—	—
PRIMARY Part 1: Number of Participants Who Discontinue Study Treatment to an AE	0; 0	—
PRIMARY Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE	—	—
PRIMARY Part 3: Number of Participants Who Discontinue Study Due to an AE	—	—
PRIMARY Part 1: Area Under the Concentration-Time Curve From 0 to Infinity (AUC0-inf) of MK-2060	14300	—
PRIMARY Part 2: AUC0-inf of MK-2060	—	—
PRIMARY Part 3: AUC0-inf of MK-2060	—	—
PRIMARY Part 1: Area Under the Concentration-Time Curve From Time 0 to 168 Hours (AUC0-168) of MK-2060	727	—
PRIMARY Part 2: AUC0-168 of MK-2060	—	—
PRIMARY Part 3: AUC0-168 of MK-2060	—	—
PRIMARY Part 1: Maximum Plasma Concentration (Cmax) of MK-2060	11.3	—
PRIMARY Part 2: Cmax of MK-2060	—	—
PRIMARY Part 3: Cmax of MK-2060	—	—
PRIMARY Part 1: Plasma Concentration at 168 Hours (C168) of MK-2060	7.19	—
PRIMARY Part 2: C168 of MK-2060	—	—
PRIMARY Part 3: C168 of MK-2060	—	—
PRIMARY Part 1: Time to Maximum Plasma Concentration (Tmax) of MK-2060	312.82	—
PRIMARY Part 2: Tmax of MK-2060	—	—
PRIMARY Part 3: Tmax of MK-2060	—	—
PRIMARY Part 1: Terminal Half Life (t1/2) of MK-2060	677	—
PRIMARY Part 2: t1/2 of MK-2060	—	—
PRIMARY Part 3: t1/2 of MK-2060	—	—
PRIMARY Part 1: Apparent Total Clearance (CL/F) of MK-2060	0.0141	—
PRIMARY Part 2: CL/F of MK-2060	—	—
PRIMARY Part 3: CL/F of MK-2060	—	—
PRIMARY Part 1: Apparent Volume of Distribution (Vz/F) of MK-2060	13.8	—
PRIMARY Part 2: Vz/F of MK-2060	—	—
PRIMARY Part 3: Vz/F of MK-2060	—	—
SECONDARY Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060	1.047; 0.977; 1.044; 0.994; 1.05; 0.971	—
SECONDARY Part 2: Percent Change From Baseline in aPTT of MK-2060	—	—
SECONDARY Part 3: Percent Change From Baseline in aPTT of MK-2060	—	—

Summary

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05656040). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.