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

CompletadoFase 2ClinicalTrials.gov

ID: NCT05027074Tipo: INTERVENTIONALInicio: 17 de sept de 2021Fin estimado: 13 de feb de 2025

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

MK-2060

MK-2060 lyophilized powder diluted in normal saline and administered via IV infusion

drug

Placebo

Normal saline administered via IV infusion

Ubicaciones

FME Mansilla ( Site 0007)

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Fresenius Medical Care - Moron ( Site 0008)

Morón, Buenos Aires, Argentina

Fresenius Medical Care - San Fernando ( Site 0013)

San Fernando, Buenos Aires, Argentina

CEREHA ( Site 0004)

Sarandí, Buenos Aires, Argentina

Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0010)

Buenos Aires, Buenos Aires F.D., Argentina

Fresenius Medical Care Ciudad Evita ( Site 0006)

Buenos Aires, Argentina

Clínica de Nefrología, Urología y Enfermedades Cardiovasculares ( Site 0001)

Santa Fe, Argentina

Patrocinadores

PrincipalMerck Sharp & Dohme LLC

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