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

Completed · Phase 1 · Has a placebo group

Conditions studied: End-Stage Renal Disease, End-Stage Kidney Disease, Kidney Failure, Chronic

In brief

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.

Key facts

Study ID

NCT05656040

Run by

Merck Sharp & Dohme LLC

People needed

14

Starts

2023-02-08

Expected to finish

2024-08-12

Last updated by the study team

2025-09-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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