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
Trial Information
Current as of February 05, 2025
Completed
Keywords
ClinConnect Summary
No description provided
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
Medical Director
Study Director
Merck Sharp & Dohme LLC
About Merck Sharp & Dohme Llc
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., is a leading global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines and vaccines that address unmet medical needs. With a strong focus on research and development, Merck Sharp & Dohme leverages advanced science and technology to enhance patient outcomes across various therapeutic areas, including oncology, infectious diseases, and cardiovascular health. Committed to ethical practices and regulatory compliance, the company actively engages in clinical trials to advance medical knowledge and improve health care for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tampa, Florida, United States
Edgewater, Florida, United States
Knoxville, Tennessee, United States
Miami, Florida, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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