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

COMPLETEDPHASE1

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

NCT05656040•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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.

Locations (4)

Velocity Clinical Research, New Smyrna Beach ( Site 0003)

Edgewater, Florida, United States

Advanced Pharma CR, LLC ( Site 0006)

Miami, Florida, United States

Genesis Clinical Research, LLC ( Site 0004)

Tampa, Florida, United States

Alliance for Multispecialty Research, LLC ( Site 0002)

Knoxville, Tennessee, United States

Key Dates

Start Date

February 8, 2023

Primary Completion Date

August 12, 2024

Completion Date

August 12, 2024

Last Updated

September 10, 2025

Enrollment

ACTUAL participants

Conditions

End-Stage Renal DiseaseEnd-Stage Kidney DiseaseKidney Failure, Chronic

Interventions

MK-2060

BIOLOGICAL

Placebo

DRUG

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Kidney Disease, End-StageEnd-stage Renal Disease+1 more

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RECRUITINGPHASE3

A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China

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HyperphosphatemiaChronic Kidney Disease, Receiving Dialysis+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System

A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China

Study to Evaluate the Safety and Efficacy of the GGTA1 KO Thymokidney in Patients With ESRD

First-in-human Study to Examine Safety of a New Peritoneal Dialysis Device (WEAKID) in End-stage Kidney Disease Patients

Predictive Value of Carotid Ultrasonography for Intradialytic Hypotension

Effects of Royal Jelly Supplementation in Chronic Kidney Disease