This study is in progress, not accepting new patients

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)

a study on End Stage Renal Disease Kidney Disease Chronic Kidney Disease Dialysis

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Anjay Rastogi (ucla)

Description

Summary

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.

Official Title

A Randomized Parallel-group, Placebo-controlled, Double-blind, Event-driven, Multi-center Phase 2 Clinical Outcome Trial of Prevention of Arteriovenous Graft Thrombosis and Safety of MK-2060 in Patients With End Stage Renal Disease Receiving Hemodialysis

Keywords

End-Stage Renal Disease, End-Stage Kidney Disease, Kidney Failure, Chronic, Kidney Diseases, Chronic Kidney Failure, Renal Insufficiency

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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.

Locations

  • DaVita Crescent Heights Dialysis Center ( Site 0574)
    Los Angeles California 90048 United States
  • California Institute of Renal Research - Kearny Mesa ( Site 0678)
    San Diego California 92111 United States
  • Fresenius Kidney Care Newhope Fountain Valley ( Site 0617)
    Fountain Valley California 92708 United States
  • DaVita Van Nuys Dialysis ( Site 0538)
    Van Nuys California 91405 United States
  • DaVita Glendale Heights ( Site 0604)
    Glendale California 91201 United States
  • Valley Renal Medical Group Research-Clinical Research ( Site 0651)
    Northridge California 91343 United States
  • DaVita West Glendale Dialysis ( Site 0579)
    Glendale California 91205 United States
  • DaVita North Glendale ( Site 0552)
    Glendale California 91206 United States
  • DaVita Kidney Center - East LA Plaza Dialysis ( Site 0548)
    Los Angeles California 90033 United States
  • DaVita Anaheim West Dialysis-Davita Anaheim West Dialysis - Ismail ( Site 0562)
    Anaheim California 92801 United States

Lead Scientist at University of California Health

  • Anjay Rastogi (ucla)
    Professor of Clinical, Medicine. Authored (or co-authored) 90 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Merck Sharp & Dohme LLC
Links
Merck Clinical Trials Information Plain Language Summary
ID
NCT05027074
Phase
Phase 2 research study
Study Type
Interventional
Participants
About 506 people participating
Last Updated