Single Dose Study of MK-2060 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacod… (NCT05769595) | Clinical Trial Compass
CompletedPhase 1
Single Dose Study of MK-2060 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Older Japanese Participants on Dialysis (MK-2060-012)
Japan17 participantsStarted 2023-06-14
Plain-language summary
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of MK-2060 after a single dose intravenous (IV) administration in Japanese older participants with end stage renal disease (ESRD) on dialysis. There is no primary hypothesis for this study.
Who can participate
Age range
50 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* Japanese descent with all 2 biological parents of Japanese descent
* On hemodialysis (HD) or hemodiafiltration (HDF) with single-pool Kt/V (spKt/V) ≥1.2, using arteriovenous (AV) fistula or AV graft ≥3 months prior to Screening 1 at a healthcare center, and is on the same dialysis regimen ≥2 weeks prior to Screening 1
* Be judged to plan to continue or anticipate the use of the current AV fistula or AV graft until the poststudy visit
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* On peritoneal dialysis or other dialysis modalities except for HD and HDF
* History of deep vein thrombosis or pulmonary embolism
* History of vascular access thrombosis within 1 month prior to Screening 1
* Personal or family history of bleeding disorder
* History of GI bleeding, duodenal polyps or active gastroduodenal ulcer within 5 years prior to Screening 1, or history of severe hemorrhoidal bleed within 3 months prior to Screening 1
* History of frequent epistaxis within 3 months prior to Screening 1 or active gingivitis
* At the time of screening or predose, planned significant dental procedures, or other planned surgical procedures within duration of participation in the trial
* History of receiving any human immunoglobulin preparation such as intravenous immunoglobulin (IVIG) or a brand of Rho(D) immune globulin (RhoGAM) within 1 year prior to …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial that has already been completed, what safety findings or adverse events were reported for older Japanese dialysis patients who received MK-2060, and how might those results be relevant to my situation?
2This study was specifically designed for older Japanese participants on dialysis — given my own background and health profile, how well do the results from this population apply to me?
3Because this was a Phase 1 single-dose study focused mainly on safety and how the body handles the drug, what is still unknown about whether MK-2060 actually helps people with end-stage kidney disease, and are there later-phase trials underway that I should know about?
4Since the trial is completed, would you be able to access or review the published or reported data, and based on what you find, do you think the safety profile of MK-2060 looks promising enough to consider for my treatment path?
5Are there currently approved treatments for end-stage kidney disease on dialysis that I should be weighing alongside emerging drugs like MK-2060, and how would you recommend I think about timing — trying standard options first versus watching for further trials of this drug?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Who Experienced an Adverse Event (AE)
Timeframe: Up to approximately 164 days
2
Number of Participants Who Discontinued Study Due to an AE