A Study of MK-2060 in Participants With Chronic Kidney Disease (MK-2060-011)
End-Stage Renal Disease, End-Stage Kidney Disease, Kidney Failure, Chronic
About this trial
This is an interventional treatment trial for End-Stage Renal Disease
Eligibility Criteria
Inclusion Criteria: At the time of screening, has stage 4 chronic kidney disease. 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.
Sites / Locations
- Velocity Clinical Research, New Smyrna Beach ( Site 0003)Recruiting
- Genesis Clinical Research, LLC ( Site 0004)Recruiting
- Alliance for Multispecialty Research, LLC ( Site 0002)Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
MK-2060
Placebo
MK-2060 administered as a single subcutaneous dose of 30 mg on Day 1
Placebo (normal saline) administered as a single subcutaneous dose on Day 1