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

Launched by MERCK SHARP & DOHME LLC · Dec 9, 2022

Keywords

ClinConnect Summary

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Gender

ALL

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.

Trial Officials