Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05027074 | 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) | PHASE2 | COMPLETED | 506 | — | — | Sep 17, 2021 | Feb 13, 2025 | Feb 11, 2026 | 120 | United States, Argentina +13 |
| NCT05656040 | A Study of MK-2060 in Participants With Chronic and/or End-Stage Kidney Disease (MK-2060-011) | PHASE1 | COMPLETED | 14 | — | — | Feb 8, 2023 | Aug 12, 2024 | Sep 10, 2025 | 4 | United States |
| NCT05335005 | MK-2060 and Clopidogrel Co-administration Safety and Tolerability Study in Participants With End-Stage Renal Disease (ESRD) (MK-2060-008) | PHASE1 | COMPLETED | 12 | — | — | May 30, 2022 | Feb 14, 2023 | Oct 17, 2024 | 3 | United States, Israel +1 |
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. A blinded independent clinical adjudication committee (CAC) adjudicated AVG thrombosis events. A time-to-event methodology was used to evaluate the results. The incidence rate is presented.
Bleeding related AEs will include any sign or symptom of bleeding, even if not requiring intervention by a medical/healthcare professional, as well as clinically relevant nonmajor bleeding or major bleeding.
Bleeding related AEs include any sign or symptom of bleeding, even if not requiring intervention by a medical/healthcare professional, as well as clinically relevant nonmajor bleeding or major bleeding.
Bleeding related AEs will include any sign or symptom of bleeding, even if not requiring intervention by a medical/healthcare professional, as well as clinically relevant nonmajor bleeding or major bleeding.
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.
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.
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.
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.
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.
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.
Blood was collected to determine the AUC0-inf of MK-2060 in plasma.
Blood was to be collected at pre-specified time points to determine the AUC0-inf of MK-2060 in plasma.
Blood was to be collected at pre-specified time points to determine the AUC0-inf of MK-2060 in plasma.
Blood was collected to determine the AUC0-168 of MK-2060 in plasma.
Blood was to be collected at pre-specified time points to determine the AUC0-168 of MK-2060 in plasma from 0 to 168 hours.
Blood was to be collected at pre-specified time points to determine the AUC0-168 of MK-2060 in plasma from 0 to 168 hours.
Blood was collected at pre-specified time points to determine the Cmax of MK-2060 in plasma.
Blood was to be collected at pre-specified time points to determine the Cmax of MK-2060 in plasma.
Blood was to be collected at pre-specified time points to determine the Cmax of MK-2060 in plasma.
Blood was collected at 168 hours post-dose to determine the C168 of MK-2060 in plasma.
Blood was to be collected at 168 hours post-dose to determine the C168 of MK-2060 in plasma.
Blood was to be collected at 168 hours post-dose to determine the C168 of MK-2060 in plasma.
Blood was collected at pre-specified time points to determine the Tmax of MK-2060 in plasma.
Blood was to be collected at pre-specified time points to determine the Tmax of MK-2060 in plasma.
Blood was to be collected at pre-specified time points to determine the Tmax of MK-2060 in plasma.
Blood was collected at pre-specified time points to determine the terminal t1/2 of MK-2060 in plasma.
Blood was to be collected at pre-specified time points to determine the terminal t1/2 of MK-2060 in plasma.
Blood was to be collected at pre-specified time points to determine the terminal t1/2 of MK-2060 in plasma.
Blood was collected at pre-specified time points to determine the CL/F of MK-2060 in plasma.
Blood was to be collected at pre-specified time points to determine the CL/F of MK-2060 in plasma.
Blood was to be collected at pre-specified time points to determine the CL/F of MK-2060 in plasma.
Blood was collected at pre-specified time points to determine the Vz/F of MK-2060 in plasma
Blood was to be collected at pre-specified time points to determine the Vz/F of MK-2060 in plasma
Blood was to be collected at pre-specified time points to determine the Vz/F of MK-2060 in plasma
Bleeding related AEs include any sign or symptom of bleeding, even if not requiring intervention by a medical/healthcare professional, as well as clinically-relevant non major bleeding or major bleeding.
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.
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.
| Arm | Type | Description |
|---|---|---|
| MK-2060 20 mg | EXPERIMENTAL | MK-2060 20 mg administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then QW after week 1 |
| MK-2060 6 mg | EXPERIMENTAL | MK-2060 6 mg administered via intravenous (IV) infusion during dialysis as a loading dose: Every other day (QOD) during week 1 (3 administrations), then once a week (QW) after week 1 |
| Placebo | PLACEBO_COMPARATOR | Placebo (normal saline) administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then once a week after week 1 |
| MK-2060 30 mg | EXPERIMENTAL | Participants received MK-2060 30 mg administered as a single subcutaneous dose on Day 1. |
| MK-2060 | EXPERIMENTAL | Participants continued their established background therapy of daily 75 mg clopidogrel for 2 weeks (days -14 to 0). Participants then continued background therapy while receiving 25 mg MK-2060 intravenous (IV) infusion on days 1, 3, 5, and 8. |
| Name | Type | Description |
|---|---|---|
| MK-2060 | DRUG | MK-2060 lyophilized powder diluted in normal saline and administered via IV infusion |
| Placebo | DRUG | Normal saline administered via IV infusion |
Inclusion Criteria: * 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 randomi...