Phase
Condition
Nephropathy
Kidney Failure (Pediatric)
Renal Failure
Treatment
MK-2060
Placebo
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
At the time of screening, has stage 4 or 5 chronic kidney disease (Parts 1 and 2) orend-state kidney disease on peritoneal dialysis (Part 3).
Has a body mass index (BMI) ≥ 18 and ≤ 45 kg/m^2.
Exclusion
Exclusion Criteria:
Has a history of cancer, including adenocarcinoma, except adequately treatednon-melanomatous skin carcinoma or carcinoma in situ of the cervix or othermalignances which have been successfully treated ≥ 5 years prior to prestudy withappropriate follow-up.
Has a history of deep vein thrombosis or pulmonary embolism, a history of vascularaccess thrombosis within 1 month prior to enrollment, or has a personal or familyhistory of bleeding disorder.
Has a history of gastrointestinal (GI) bleeding, duodenal polyps, or gastric ulcerin 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 activegingivitis.
Has ongoing anticoagulant therapy or antiplatelet therapy. Aspirin is permitted.
Has planned significant dental procedures at the time of screening or pre-dose orother 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 preparationsuch as intravenous immunoglobulin (IVIG) or RhoGAM within the last year.
Has a history (participant recall) of receiving any biological therapy (includinghuman blood products or monoclonal antibodies; excluding erythropoietin and insulin)within the last 3 months or vaccination within the last 1 month, except the seasonalflu and pneumococcal vaccine or COVID-19 vaccine.
Study Design
Connect with a study center
Velocity Clinical Research, New Smyrna Beach ( Site 0003)
Edgewater, Florida 32132
United StatesSite Not Available
Advanced Pharma CR, LLC ( Site 0006)
Miami, Florida 33147
United StatesSite Not Available
Genesis Clinical Research, LLC ( Site 0004)
Tampa, Florida 33603
United StatesSite Not Available
Alliance for Multispecialty Research, LLC ( Site 0002)
Knoxville, Tennessee 37920
United StatesSite Not Available
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