End-Stage Renal Disease (ESRD)Phase 1NCT05769595
Single Dose Study of MK-2060 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Older Japanese Participants on Dialysis (MK-2060-012)
A Phase 1 study testing MK-2060 in people with End-Stage Renal Disease (ESRD) and End-Stage Kidney Disease (ESKD), run by Merck Sharp & Dohme LLC at 12 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- End-Stage Renal Disease (ESRD), End-Stage Kidney Disease (ESKD), Kidney Failure, Chronic
- What is being tested?
- MK-2060
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 12 sitesJapan
- Study dates
- 14 Jun 2023to 15 Feb 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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 Screening 1
- History of receiving any biological therapy within 3 months prior to Screening 1, or vaccination within 1 month prior to the dose of study intervention
- Requires or anticipates requiring the use of following prohibited medications until the poststudy visit: anticoagulants, antiplatelet medications and non-steroidal anti-inflammatory drugs (NSAIDs)
- Participated in another investigational study within 1 month prior to Screening 1
- Has blood coagulation test (activated partial thromboplastin time [aPTT] or prothrombin time [PT]) above 1.2X upper limit of normal (ULN) at Screening 1 from the central laboratory for safety
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Japan12 sites
Keiaikai Nakamura Hospital ( Site 1213)
Beppu, Oita Prefecture, 874-0937
Japanese Red Cross Fukuoka Hospital ( Site 1214)
Fukuoka, 815-8555
Shonan Kamakura General Hospital ( Site 1205)
Kamakura, Kanagawa, 247-8533
Ibaraki Prefectural Central Hospital ( Site 1211)
Kasama, Ibaraki, 309-1793
Kasugai Municipal Hospital ( Site 1203)
Kasugai, Aichi-ken, 486-8510
Omi Fureai Hospital ( Site 1204)
Kusatsu, Shiga, 525-8585
Jomo Ohashi Clinic ( Site 1210)
Maebashi, Gunma, 371-0046
Matsumoto City Hospital ( Site 1209)
Matsumoto, Nagano, 390-1401
Chubu Rosai Hospital ( Site 1202)
Nagoya, Aichi-ken, 455-8530
Kojunkai Daido Hospital ( Site 1207)
Nagoya, Aichi-ken, 457-8511
Ikegami General Hospital ( Site 1206)
Ōta-ku, Tokyo, 146-8531
Yamagata Tokushukai Hospital ( Site 1201)
Yamagata, 990-0834
About this study
Official title: A Single-dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-2060 in Japanese Older Participants With End-stage Renal Disease on Dialysis.
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.
- Being tested
- MK-2060, Placebo
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-2060Biological
Lyophilized powder diluted in normal saline for IV infusion
PlaceboDrug
Also called Normal saline
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| MK-2060 | Experimental | Participants receive MK-2060 50 mg via a single intravenous (IV) infusion over 60-minutes. Receives: Biological: MK-2060 |
| Placebo | Placebo comparator | Participants receive a single IV saline infusion over 60 minutes. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced an Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The number of participants who experienced an AE is reported.
Measured: Up to approximately 164 days
Number of Participants Who Discontinued Study Due to an AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The number of participants who discontinued study due to an AE is reported.
Measured: Up to approximately 164 days
Secondary outcomes (11)
Area Under the Concentration-Time Curve of MK-2060 From Time 0 to Infinity (AUC 0-inf)
Blood samples were collected at specified intervals for the determination of AUC0-inf. AUC0-inf is defined as the area under the concentration-time curve of MK-2060 from time zero to infinity.
Measured: Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis
Area Under the Plasma Concentration-Time Curve of MK-2060 From Time 0 to Last (AUC0-last)
Blood samples were collected at specified intervals for the determination of AUC0-last. AUC0-last is defined as the area under the plasma concentration-time curve from time zero to time of last measurable concentration of MK-2060.
Measured: Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis
Area Under the Concentration-Time Curve of MK-2060 From Time 0 to 168 Hours Postdose (AUC0-168)
Blood samples were collected at specified intervals for the determination of AUC0-168. AUC0-168 is defined as the area under the concentration-time curve of MK-2060 from time zero to 168 hours.
Measured: Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis
Maximum Concentration (Cmax) of MK-2060
Blood samples were collected at specified intervals for the determination of Cmax. Cmax is defined as the maximum concentration of MK-2060 reached.
Measured: Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis
Concentration at 168 Hours (C168) Postdose of MK-2060
Blood samples were collected at specified intervals for the determination of C168. C168 is defined as the maximum concentration of MK-2060 reached at 168 hours postdose.
Measured: Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis
Time to Maximum Concentration (Tmax) of MK-2060
Blood samples were collected at specified intervals for the determination of Tmax. Tmax is defined as time to the maximum concentration of MK-2060 reached.
Measured: Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis
Time of the Last Measurable Plasma Concentration (Tlast) of MK-2060
Blood samples were collected at specified intervals for the determination of Tlast. Tlast is defined as the time to the last measurable concentration of MK-2060 reached.
Measured: Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis
Terminal Half-Life (t ½) of MK-2060
Blood samples were collected at specified intervals for the determination of t½. t½ is defined as the time required to divide the MK-2060 plasma concentration by two after reaching pseudo-equilibrium, following a single dose of MK-2060.
Measured: Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis
Clearance (CL) of MK-2060
Blood samples were collected at specified intervals for the determination of CL. CL is the volume of plasma from which the study drug is completely removed per unit time.
Measured: Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis
Volume of Distribution (Vz) of MK-2060
Blood samples were collected at specified intervals for the determination of Vz. Vz is the apparent volume of distribution during the terminal phase.
Measured: Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis
Change From Baseline in Activated Partial Thromboplastin Time (aPTT)
Blood samples were collected for the determination of aPTT. Change from baseline in aPTT up to 168 hours post dose (pre dialysis) is reported.
Measured: Baseline and 168 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start14 Jun 2023
- Primary completion15 Feb 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for End-Stage Renal Disease (ESRD)Studies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769595
- Sponsor's protocol ID
- 2060-012
- Other IDs
- MK-2060-012, jRCT2041230025
- Status last verified
- Feb 2025
- First submitted
- 3 Mar 2023
- Last updated
- 14 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-2060 in Japanese Older Participants With End-stage Renal Disease on Dialysis.
- ClinicalTrials.gov ID
- NCT05769595
- Acronym / sponsor ID
- 2060-012
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 15 Mar 2023 (actual)
- Results
- Posted 14 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MK-2060 | Experimental | Biological: MK-2060Participants receive MK-2060 50 mg via a single intravenous (IV) infusion over 60-minutes. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants receive a single IV saline infusion over 60 minutes. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK-2060Lyophilized powder diluted in normal saline for IV infusion | Biological | MK-2060 |
| PlaceboAlso: Normal salineIV infusion | Drug | Placebo |
Primary outcome
Number of Participants Who Experienced an Adverse Event (AE)
Time frame: Up to approximately 164 days
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The number of participants who experienced an AE is reported.
Number of Participants Who Discontinued Study Due to an AE
Time frame: Up to approximately 164 days
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The number of participants who discontinued study due to an AE is reported.
11 secondary outcomes
Area Under the Concentration-Time Curve of MK-2060 From Time 0 to Infinity (AUC 0-inf)
Time frame: Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis
Area Under the Plasma Concentration-Time Curve of MK-2060 From Time 0 to Last (AUC0-last)
Time frame: Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis
Area Under the Concentration-Time Curve of MK-2060 From Time 0 to 168 Hours Postdose (AUC0-168)
Time frame: Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis
Maximum Concentration (Cmax) of MK-2060
Time frame: Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis
Concentration at 168 Hours (C168) Postdose of MK-2060
Time frame: Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis
Time to Maximum Concentration (Tmax) of MK-2060
Time frame: Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis
Time of the Last Measurable Plasma Concentration (Tlast) of MK-2060
Time frame: Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis
Terminal Half-Life (t ½) of MK-2060
Time frame: Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis
Clearance (CL) of MK-2060
Time frame: Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis
Volume of Distribution (Vz) of MK-2060
Time frame: Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis
Change From Baseline in Activated Partial Thromboplastin Time (aPTT)
Time frame: Baseline and 168 hours post dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-2060 in people with End-Stage Renal Disease (ESRD) and End-Stage Kidney Disease (ESKD), run by Merck Sharp & Dohme LLC at 12 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experienced an Adverse Event (AE) (time frame: Up to approximately 164 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.