Global Study of MK-2060 (Anti-Factor XI Monoclonal Antibody) in Participants With End Stage Renal Disease Receiving Hemodialysis (FXI Hemodialysis Study) (MK-2060-007)

Completed · Phase 2 · Has a placebo group

Conditions studied: End-Stage Renal Disease, End-Stage Kidney Disease, Kidney Failure, Chronic

In brief

The purpose of this study is to evaluate the efficacy and safety of two different doses of MK-2060 (a monoclonal antibody against Factor XI) in end stage renal disease (ESRD) participants receiving hemodialysis via an arteriovenous graft (AVG). Data from this study will be used to aid dose selection of MK-2060 in future studies. The primary hypothesis is that at least one of the MK-2060 doses is superior to placebo in increasing the time to first occurrence of AVG event.

Key facts

Study ID

NCT05027074

Run by

Merck Sharp & Dohme LLC

People needed

506

Starts

2021-09-17

Expected to finish

2025-02-13

Last updated by the study team

2026-02-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Current diagnosis of ESRD.
• Receiving hemodialysis (including hemodiafiltration) ≥3 times per week for a minimum of 3 hours per session via a mature normally functioning, uninfected AVG with at least 75% of the sessions meeting these criteria over the 4 weeks prior to randomization.
• A female participant is not pregnant or breastfeeding, not a woman of child-bearing potential (WOCBP) or is a WOCBP and agrees to follow contraceptive guidance during the intervention period and for at least 90 days after the last dose of study intervention.

You may not qualify if…

• Recent history of cancer (<1 year). Non-melanoma skin cancers are allowed.
• Mechanical/prosthetic heart valve.
• Recent hemorrhagic stroke or lacunar stroke (<1 month).
• Recent evidence (<1 month) of bleeding requiring hospitalization or unplanned medical attention, a history (≤2 years) of recurrent bleeding episodes including epistaxis, gastrointestinal (GI) bleeds or genitourinary (GU) bleeds requiring medical treatment or events requiring treatment with blood products.
• Recent history (<1 year) of drug or alcohol abuse or dependence.
• Currently receiving or planning to receive anticoagulants or antiplatelet medications (intradialytic heparin and aspirin are permitted).
• Planning on receiving a living donor renal transplant within 12 months (participants are permitted to be candidates for deceased donor renal transplants).
• Planning on receiving an arteriovenous fistula (AVF) placement within 12 months.

Where it is running

• AKDHC MEDICAL RESEARCH SERVICES, LLC-Maryvale ( Site 0723) — Phoenix, Arizona, United States
• AKDHC Medical Research Services, LLC ( Site 0629) — Tucson, Arizona, United States
• DaVita Anaheim West Dialysis-Davita Anaheim West Dialysis - Ismail ( Site 0562) — Anaheim, California, United States
• DaVita Bakersfield Oak Street Dialysis-Clinical Research ( Site 0547) — Bakersfield, California, United States
• Fresenius Kidney Care Bakersfield Northeast ( Site 0647) — Bakersfield, California, United States
• Fresenius Kidney Care Meadows Field ( Site 0618) — Bakersfield, California, United States
• California Institute Of Renal Research ( Site 0660) — Chula Vista, California, United States
• Citrus Dialysis Center ( Site 0609) — Covina, California, United States
• California Institute Of Renal Research ( Site 0679) — El Centro, California, United States
• California Institute of Renal Research ( Site 0566) — Escondido, California, United States
• Fresenius Kidney Care Newhope Fountain Valley ( Site 0617) — Fountain Valley, California, United States
• DaVita Glendale Heights ( Site 0604) — Glendale, California, United States
• DaVita West Glendale Dialysis ( Site 0579) — Glendale, California, United States
• DaVita North Glendale ( Site 0552) — Glendale, California, United States
• California Institute of Renal Research - La Mesa ( Site 0682) — La Mesa, California, United States
• La Puente Dialysis Center ( Site 0610) — La Puente, California, United States
• Academic Medical Research Institute ( Site 0533) — Los Angeles, California, United States
• DaVita Kidney Center - East LA Plaza Dialysis ( Site 0548) — Los Angeles, California, United States
• DaVita Crescent Heights Dialysis Center ( Site 0574) — Los Angeles, California, United States
• North America Research Institute ( Site 0587) — Lynwood, California, United States
• North America Research Institute ( Site 0612) — Lynwood, California, United States
• Valley Renal Medical Group Research-Clinical Research ( Site 0651) — Northridge, California, United States
• California Institute of Renal Research - Kearny Mesa ( Site 0678) — San Diego, California, United States
• North America Research Institute ( Site 0611) — San Dimas, California, United States
• Nephrology Consultants ( Site 0681) — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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