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

Sponsor
Merck Sharp & Dohme Corp. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05027074
Collaborator
(none)
489
Enrollment
19
Locations
3
Arms
19
Anticipated Duration (Months)
25.7
Patients Per Site
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
489 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Sep 17, 2021
Anticipated Primary Completion Date :
Mar 27, 2023
Anticipated Study Completion Date :
Apr 18, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: MK-2060 Low Dose

MK-2060 low dose administered via intravenous (IV) infusion as a loading dose: Every other day (QOD) during week 1 (3 administrations), then once a week (QW) after week 1

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

Experimental: MK-2060 High Dose

MK-2060 high dose administered via IV infusion as a loading dose: QOD during week 1 (3 administrations), then QW after week 1

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

Placebo Comparator: Placebo

Placebo (normal saline) administered via IV infusion as a loading dose: QOD during week 1 (3 administrations), then once a week after week 1

Drug: Placebo
Normal saline administered via IV infusion

Outcome Measures

Primary Outcome Measures

  1. Time to First AVG Thrombosis Event [From date of randomization until the date of first occurrence of an AVG thrombosis event, assessed up to approximately 17 months]

    An AVG thrombosis event is defined as the sudden occlusion of the participant's AVG requiring thrombectomy/thrombolysis, or clinical evidence of thrombosis with surgical, radiological or pathological conformation of an AVG thrombosis. This endpoint will be adjudicated by an independent clinical adjudication committee (CAC).

Secondary Outcome Measures

  1. Number of AVG Thrombosis Events [Up to approximately 17 months]

    An AVG thrombosis event is defined as the sudden occlusion of the participant's AVG requiring thrombectomy/thrombolysis, or clinical evidence of thrombosis with surgical, radiological or pathological conformation of an AVG thrombosis. This endpoint will be adjudicated by an independent CAC.

  2. Number of Participants who Experience One or More Adverse Events (AEs) [Up to approximately 20 months]

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

  3. Number of Major Bleeding Events or Clinically Relevant Non-Major Bleeding Events per International Society on Thrombosis (ISTH) Criteria [Up to approximately 20 months]

    Major bleeding events will be defined as having a symptomatic presentation and including one or more of the following criteria: 1) Fatal bleeding 2) Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, intramuscular with compartment syndrome, 3) Bleeding causing a decrease in hematocrit level of 20 g/L or more or leading to transfusion of 2 or more units of whole blood or red cells. Clinically relevant non-major bleeding events will be defined as having signs or symptoms of hemorrhage that do not meet the criteria for major bleeding events, but do meet at least 1 of the following criteria: 1) Requiring medical intervention by a healthcare professional 2) Leading to hospitalization or increased level of care 3) Prompting a face to face evaluation by a healthcare professional.

  4. Number of Participants Who Discontinue Study Intervention Due to an AE [Up to approximately 17 months]

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Current diagnosis of ESRD.

  • Receiving hemodialysis ≥3 times per week with each hemodialysis session being a minimum of 3 hours duration via a normally functioning, uninfected AVG for at least 4 weeks.

  • 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.

Exclusion Criteria:
  • 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.

  • 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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Citrus Dialysis Center ( Site 0609)CovinaCaliforniaUnited States91723
2DaVita West Glendale Dialysis ( Site 0579)GlendaleCaliforniaUnited States91205
3La Puente Dialysis Center ( Site 0610)La PuenteCaliforniaUnited States91744
4Academic Medical Research Institute ( Site 0533)Los AngelesCaliforniaUnited States90022
5North America Research Institute ( Site 0587)LynwoodCaliforniaUnited States90262
6North America Research Institute ( Site 0612)LynwoodCaliforniaUnited States90262
7Valley Renal Medical Group Research-Clinical Research ( Site 0651)NorthridgeCaliforniaUnited States91343
8Desert Cities Diaylsis-Clinical Research ( Site 0615)VictorvilleCaliforniaUnited States92392
9Elixia at Florida Kidney Physicians - Southeast ( Site 0602)Fort LauderdaleFloridaUnited States33308
10South Florida Research Institute ( Site 0656)Fort LauderdaleFloridaUnited States33313
11Pines Clinical Research ( Site 0605)HollywoodFloridaUnited States33024
12Omega Research MetroWest ( Site 0645)OrlandoFloridaUnited States32835
13Genesis Clinical Research ( Site 0585)TampaFloridaUnited States33603
14Genesis Clinical Research ( Site 0594)TampaFloridaUnited States33603
15Genesis Clinical Research ( Site 0680)TampaFloridaUnited States33603
16Durham Nephrology Associates ( Site 0655)DurhamNorth CarolinaUnited States27704
17South Carolina Nephrology & Hypertension Center-Research ( Site 0672)OrangeburgSouth CarolinaUnited States29118
18Texas Institute for Kidney and Endocrine Disorders ( Site 0626)LufkinTexasUnited States75904
19Western Health-Sunshine & Footscray Hospitals-Renal Services ( Site 0054)St AlbansVictoriaAustralia3021

Sponsors and Collaborators

  • Merck Sharp & Dohme Corp.

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme Corp.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT05027074
Other Study ID Numbers:
  • 2060-007
  • 2020-002397-27
  • MK-2060-007
First Posted:
Aug 30, 2021
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 19, 2021