NCT05656040CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 10 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 14 (actual)
- First submitted
- 9 Dec 2022
- Start date
- 8 Feb 2023
- Primary completion date
- 12 Aug 2024
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Chronic kidney disease
- NCT number
- NCT05656040
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 14
- From 8 Feb 2023 to the primary completion date, 12 Aug 2024
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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.
- 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.
Other illness
- 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.
- Is positive for hepatitis B surface antigen or human immunodeficiency virus (HIV).
Age
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Velocity Clinical Research, New Smyrna Beach ( Site 0003) Coordinator of this site? Confirm its status | Edgewater | United States | Unknown status |
| Alliance for Multispecialty Research, LLC ( Site 0002) Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| Advanced Pharma CR, LLC ( Site 0006) Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Genesis Clinical Research, LLC ( Site 0004) Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.