Renal DialysisPhase 1NCT03873038
Safety and Pharmacokinetics of MK-2060 in Older Participants With End-Stage Renal Disease on Hemodialysis (MK-2060-004)
A Phase 1 study testing MK-2060 in people with Renal Dialysis and Kidney Failure, Chronic, run by Merck Sharp & Dohme LLC at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-2060 after intravenous (IV) administration of single and multiple doses in older adult participants with end-stage renal disease (ESRD) on hemodialysis (HD). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Dialysis, 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
- 38 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Apr 2019to 20 Dec 2021
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, of non-child bearing potential (WONCBP) age ≥40 and ≤80 years for Part 1 and ≥18 and ≤80 years for Part 2.
- End-stage renal disease (ESRD) maintained on stable outpatient hemodialysis (HD) regimen, using an established (> 3 months) and normally functioning, regular flow, uninfected mature arteriovenous (AV) fistula or AV graft and skin consistent with standard chronic HD access injuries, and HD stability defined as ([K, dialyzer clearance, multiplied by t, time, divided by V, patient's total body water] Kt/V) ≥ 1.2 within 3 months prior to dosing at a healthcare center for > 3 months from dosing.
- On HD regimen at least 3 times per week for a minimum of 3 hours per dialysis session, using a complication-free well-maintained AV fistula or AV graft, expected and plan to continue this throughout and for at least 3 months beyond the study.
- Has a Body Mass Index (BMI) ≥ 18 and ≤ 45 kg/m^2, BMI = weight (kg)/height (m)^2.
- Baseline health is judged to be stable based on medical history, physical examination, vital sign measurements and electrocardiogram (ECG) performed prior to randomization.
- Liver function test (serum alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) must be equal to or below 1.5X upper limit of normal (ULN) and deemed not clinically significant by both the investigator and the Sponsor.
- Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies by agreeing to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant. Also, men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.
- Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies in that a female participant is eligible to participate if she is not pregnant or breastfeeding and she is not a WOCBP in that she is a postmenopausal female without menses for at least 1 year OR is a surgically sterile female, post hysterectomy, bilateral salpingectomy, oophorectomy or tubal ligation.
Who cannot join
- Has a history of any clinically significant concomitant disease or condition (including treatment for such conditions) or diseases whose current condition is considered clinically unstable that, in the opinion of the investigator, could either interfere with the study drug, compromise interpretation of study data, or pose an unacceptable risk. Participants with a remote history of uncomplicated medical events (e.g., uncomplicated kidney stones, as defined as spontaneous passage and no recurrence in the last 5 years, or childhood asthma) may be enrolled in the study at the discretion of the investigator.
- Is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years. Participants who have had situational depression may be enrolled in the study at the discretion of the investigator.
- Has a history of cancer (malignancy), including adenocarcinoma, with possible exceptions being participants with adequately treated non-melanomatous skin carcinoma; participants with other malignancies which have been successfully treated ≥10 years prior to the pretrial (screening) visit; or participants who, in the opinion of the trial investigator, are highly unlikely to sustain a recurrence for the duration of the trial.
- Has blood coagulation test (activated partial thromboplastin time [aPTT], prothrombin time [PT]) ≥ 20 % outside of normal range on pretrial (screening), which are considered clinically significant by both the investigator and the sponsor.
- Any other clinically significant abnormalities in laboratory test results at screening that would, in the opinion of the investigator, increase the participant's risk of participation, jeopardize complete participation in the study, or compromise interpretation of study data.
- Has a history of deep vein thrombosis or pulmonary embolism. Has a history of vascular access thrombosis within 1 month prior to enrollment. Has a personal or family history of bleeding disorder.
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- Has a history of gastrointestinal (GI) bleeding, duodenal polyps or gastric ulcer in the last 5 years or severe hemorrhoidal bleed in last 3 months.
- Has a history of or current frequent epistaxis within the last 3 months or active gingivitis.
- Has ongoing anticoagulant therapy (warfarin, apixaban, dabigatran, rivaroxaban, edoxaban, betrixaban) or antiplatelet therapy (clopidogrel, prasugrel, ticagrelor, ticlopidine). Intradialytic heparin and aspirin are permitted.
- At the time of screening or pre-dose, has planned significant dental procedures (including planned dental surgery), or other planned surgical procedures within duration of participation in the trial.
- Is positive for hepatitis B surface antigen or human immunodeficiency viruses (HIV).
- Has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the pre-study (screening) visits.
- Has a history of significant multiple and/or severe allergies (e.g. food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (i.e. systemic allergic reaction) to prescription or non-prescription drugs or food.
- Has a tattoo, scar, or other physical finding at the area of the infusion site that would interfere with infusion or a local tolerability assessment.
- Has a history of receiving any human immunoglobulin preparation such as intravenous immunoglobulin (IVIG) or RhoGAM within the last year.
- Has a history of receiving any biological therapy (including human blood products or monoclonal antibodies; excluding erythropoietin and insulin) within the last 3 months or 5 half-lives (whichever is longer), or vaccination within the last 1 month (exceptions include seasonal flu vaccine and pneumococcal vaccine within the last month; coronavirus disease 2019 [COVID-19] vaccine that is licensed and approved for emergency use and with the study intervention given 72 hours following vaccination or 48 hours prior to vaccination).
- The exclusion criteria for ECG is a heart rate < 40 or > 110 beats per minute (bpm); corrected Q-T (QTc) interval > 500 minutes/second; any significant arrhythmia or conduction abnormality, (including but not specific to atrioventricular block [2nd degree or higher], Wolff Parkinson White syndrome [unless curative radio ablation therapy]), which, in the opinion of the investigator and sponsor, could interfere with the safety for the individual participant; and non-sustained or sustained ventricular tachycardia (> 2 consecutive ventricular ectopic beats at a rate of > 1.7/second).
- Is unable to refrain from or anticipates the use of medication, including prescription and nonprescription drugs or herbal remedies beginning approximately 2 weeks prior to administration of the initial dose of study drug, throughout the study until the poststudy visit. Specific allowed and prohibited medications are provided in the protocol.
- Has participated in another investigational study within 4 weeks prior to sponsor's investigational drug (MK-2060/placebo) administration.
- Has a blood pressure >190 mmHg systolic or >110 mmHg diastolic.
- Consumes greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer 354 mL/12 ounces, wine 118 mL/4 ounces, or distilled spirits 29.5 mL/1 ounce) per day. Participants who consume 4 glasses of alcoholic beverages per day may be enrolled at the discretion of the investigator.
- Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.
- Is a regular user of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 2 years. Participants must have a negative serum or saliva drug screen prior to randomization. Participants with a positive drug screen due to the use of physician prescribed medications (e.g., opioids, benzodiazepines, antidepressants) may be enrolled at the discretion of the investigator. In addition, participants with a positive tetrahydrocannabinol (THC) may be enrolled at the discretion of the investigator if the participants' THC use is under 4 times/month and the participants agree to not use during their study participation. Participants with positive THC on screening may have rechecks performed at the discretion of the investigator to ensure compliance with abstinence from THC use during study participation.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
New Orleans Center for Clinical Research ( Site 0001)
Knoxville, Tennessee, 37920
Orlando Clinical Research Center ( Site 0002)
Orlando, Florida, 32809
Prism Research ( Site 0003)
Saint Paul, Minnesota, 55114
About this study
Official title: Single and Multiple Dose Clinical Trial to Study the Safety and Pharmacokinetics of MK-2060 in Older Participants With End-Stage Renal Disease on Hemodialysis
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-2060 after intravenous (IV) administration of single and multiple doses in older adult participants with end-stage renal disease (ESRD) on hemodialysis (HD).
- Conditions
- Renal Dialysis, Kidney Failure, Chronic
- 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-2060Drug
Part 1: Single doses (8 mg, 20 mg, or 40 mg) of MK-2060 will be administered via IV infusion on Day 1.
Part 2: Three doses of 25 mg of MK- 2060 administered via IV infusion on Days 1, 3 and 5; Followed by single doses of 25 mg of MK-2060 administered via IV infusion on Days 8, 15, and 22.
PlaceboDrug
Part 1: Single dose of placebo will be administered via IV infusion on Day 1. Part 2: Three doses of placebo administered via IV infusion on Days 1, 3 and 5; Followed by single doses of placebo administered via IV infusion on Days 8, 15, and 22.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Panel A- MK-2060 (8 mg) | Experimental | Participants will receive a single 8-mg dose of MK-2060 via intravenous (IV) infusion. Receives: Drug: MK-2060 |
| Part 1: Panel B- MK-2060 (20 mg) | Experimental | Participants will receive a single 20-mg dose of MK-2060 via IV infusion. Receives: Drug: MK-2060 |
| Part 1: Panel C- MK-2060 (40 mg) | Experimental | Participants will receive a single 40-mg dose of MK-2060 via IV infusion. Receives: Drug: MK-2060 |
| Part 1: Placebo | Placebo comparator | Participants will receive a single dose of placebo via IV infusion. Receives: Drug: Placebo |
| Part 2: MK-2060 25-mg Loading/ 25-mg Maintenance | Experimental | Participants will receive three doses of up to 25 mg MK-2060 via IV infusion in the first week (Week 1), followed by a single dose of up to 25 mg MK-2060 via IV infusion weekly for 3 weeks (Weeks 2-4) Receives: Drug: MK-2060 |
| Part 2: Placebo | Placebo comparator | Participants will receive three doses of placebo via IV infusion in the first week and then a single dose of placebo via IV infusion weekly for 3 weeks (Weeks 2-4) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Percentage of Participants With Any Adverse Event (AE)
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. The percentage of participants that experienced an AE was summarized.
Measured: Up to 164 days
Part 2: Percentage of Participants With Any AE
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. The percentage of participants who experienced an AE was summarized.
Measured: Up to 118 days
Part 1: Percentage of Participants With Any Serious Adverse Event
A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants who experienced an SAE was summarized.
Measured: Up to 164 days
Part 2: Percentage of Participants With Any SAE
An SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants who experienced an SAE was summarized.
Measured: Up to 118 days
Part 1: Percentage of Participants With a Systemic AE
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. The solicited systemic AEs assessed included but not limited to fever, vital sign (VS) changes (tachycardia/hypotension), pruritis, urticarial (hives), lip swelling, angioedema, bronchospasm, stridor, hoarseness, and shortness of breath.
Measured: Up to 164 days
Part 2: Percentage of Participants With a Systemic AE
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. The solicited systemic AEs assessed included but not limited to fever, vital sign (VS) changes (tachycardia/hypotension), pruritis, urticarial (hives), lip swelling, angioedema, bronchospasm, stridor, hoarseness, and shortness of breath.
Measured: Up to 118 days
Part 1: Percentage of Participants With an Injection-Site AE
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. The solicited injection-site AEs assessed were pain, tenderness, erythema/redness, and induration/swelling.
Measured: Up to 164 days
Part 2: Percentage of Participants With an Injection-Site AE
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. The solicited injection-site AEs assessed were pain, tenderness, erythema/redness, and induration/swelling.
Measured: Up to 118 days
Part 1: Percentage of Participants Discontinuing the Study Due to an AE
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. The percentage of participants that discontinued the study due to an AE was summarized.
Measured: Up to 164 days
Part 2: Percentage of Participants Discontinuing Study Drug Due to an AE
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. The percentage of participants that had study drug discontinued regardless of study completion status was summarized.
Measured: Up to 4 weeks
Secondary outcomes (14)
Part 1: Area Under the Plasma Concentration-Time Curve of MK-2060 From 0 to Infinity (AUC0-inf)
Plasma samples were collected at pre-specified time points post-dose and AUC0-inf was assessed.
Measured: Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdose, then Days 12, 15, 22, 29, 60, 90, 120, 150
Part 1: Area Under the Plasma Concentration-Time Curve of MK-2060 From Time 0 to 168 Hours (AUC0-168)
Plasma samples were collected at pre-specified time points post-dose and AUC0-168 hours was assessed.
Measured: Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdose
Part 1: Maximum Observed Plasma Concentration (Cmax) of MK-2060
Plasma samples were collected at pre-specified time points post-dose and Cmax was assessed.
Measured: Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdose, then Days 12, 15, 22, 29, 60, 90, 120, 150
Part 1: Plasma Concentration of MK-2060 at 168 Hours (C168)
Plasma samples were collected at 168 hours post-dose and C168 was assessed.
Measured: 168 hours post dose
Part 1: Time to Maximum Observed Plasma Drug Concentration (Tmax) of MK-2060
Plasma samples were collected at pre-specified time points post-dose and Tmax was assessed.
Measured: Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdose
Part 1: Plasma Elimination Terminal Half-life (t ½) of MK-2060
Plasma samples was collected at pre-specified time points post-dose and t ½ was assessed.
Measured: Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdose
Part 1: Plasma Clearance (CL) of MK-2060
Plasma samples were collected at pre-specified time points post-dose and CL was assessed.
Measured: Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdose
Part 1: Plasma Volume of Distribution (Vz) of MK-2060
Plasma samples were collected at pre-specified time points post-dose and Vz was assessed.
Measured: Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdose
Part 2: AUC0-168 of MK-2060
Plasma samples were collected at pre-specified time points post-dose and AUC0-168 hours was assessed.
Measured: Up to 168 hours on Day 1 and Day 22
Part 2: Cmax of MK-2060
Plasma samples were collected at pre-specified time points post-dose and Cmax was assessed.
Measured: Day 1 and Day 22
Part 2: C168 of MK-2060
Plasma samples were collected at 168 hours post-dose and C168 was assessed.
Measured: 168 hours post dose on Days 1 and 22
Part 2: Tmax of MK-2060
Plasma samples were collected at pre-specified time points post-dose and Tmax was assessed.
Measured: Day 1 and Day 22
Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060: Part 1
Plasma samples were collected at pre-specified time points post-dose and aPTT values were assessed. The fold change (Day 8/Baseline) at Day 8 was reported.
Measured: Baseline and 168 hours post-dose (Day 8)
Fold Change From Baseline in aPTT of MK-2060: Part 2
Plasma samples were collected at pre-specified time points post-dose and aPTT values were assessed. The fold change (Day 8/Baseline) at Day 8 was reported.
Measured: Baseline and Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start29 Apr 2019
- Primary completion20 Dec 2021
- Study completion20 Dec 2021
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 Renal DialysisStudies 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
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 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
- NCT03873038
- Sponsor's protocol ID
- 2060-004
- Other IDs
- MK-2060-004
- Status last verified
- Jun 2024
- First submitted
- 12 Mar 2019
- Last updated
- 6 Jun 2024
- 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 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single and Multiple Dose Clinical Trial to Study the Safety and Pharmacokinetics of MK-2060 in Older Participants With End-Stage Renal Disease on Hemodialysis
- ClinicalTrials.gov ID
- NCT03873038
- Acronym / sponsor ID
- 2060-004
- Conditions
- Renal Dialysis, Kidney Failure, Chronic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 13 Mar 2019 (actual)
- Results
- Posted 6 Jun 2024
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 evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-2060 after intravenous (IV) administration of single and multiple doses in older adult participants with end-stage renal disease (ESRD) on hemodialysis (HD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1: Panel A- MK-2060 (8 mg) | Experimental | Drug: MK-2060Participants will receive a single 8-mg dose of MK-2060 via intravenous (IV) infusion. |
| Part 1: Panel B- MK-2060 (20 mg) | Experimental | Drug: MK-2060Participants will receive a single 20-mg dose of MK-2060 via IV infusion. |
| Part 1: Panel C- MK-2060 (40 mg) | Experimental | Drug: MK-2060Participants will receive a single 40-mg dose of MK-2060 via IV infusion. |
| Part 1: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single dose of placebo via IV infusion. |
| Part 2: MK-2060 25-mg Loading/ 25-mg Maintenance | Experimental | Drug: MK-2060Participants will receive three doses of up to 25 mg MK-2060 via IV infusion in the first week (Week 1), followed by a single dose of up to 25 mg MK-2060 via IV infusion weekly for 3 weeks (Weeks 2-4) |
| Part 2: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive three doses of placebo via IV infusion in the first week and then a single dose of placebo via IV infusion weekly for 3 weeks (Weeks 2-4) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, of non-child bearing potential (WONCBP) age ≥40 and ≤80 years for Part 1 and ≥18 and ≤80 years for Part 2.
- End-stage renal disease (ESRD) maintained on stable outpatient hemodialysis (HD) regimen, using an established (> 3 months) and normally functioning, regular flow, uninfected mature arteriovenous (AV) fistula or AV graft and skin consistent with standard chronic HD access injuries, and HD stability defined as ([K, dialyzer clearance, multiplied by t, time, divided by V, patient's total body water] Kt/V) ≥ 1.2 within 3 months prior to dosing at a healthcare center for > 3 months from dosing.
- On HD regimen at least 3 times per week for a minimum of 3 hours per dialysis session, using a complication-free well-maintained AV fistula or AV graft, expected and plan to continue this throughout and for at least 3 months beyond the study.
- Has a Body Mass Index (BMI) ≥ 18 and ≤ 45 kg/m^2, BMI = weight (kg)/height (m)^2.
- Baseline health is judged to be stable based on medical history, physical examination, vital sign measurements and electrocardiogram (ECG) performed prior to randomization.
Key exclusion criteria (23 listed)
- Has a history of any clinically significant concomitant disease or condition (including treatment for such conditions) or diseases whose current condition is considered clinically unstable that, in the opinion of the investigator, could either interfere with the study drug, compromise interpretation of study data, or pose an unacceptable risk. Participants with a remote history of uncomplicated medical events (e.g., uncomplicated kidney stones, as defined as spontaneous passage and no recurrence in the last 5 years, or childhood asthma) may be enrolled in the study at the discretion of the investigator.
- Is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years. Participants who have had situational depression may be enrolled in the study at the discretion of the investigator.
- Has a history of cancer (malignancy), including adenocarcinoma, with possible exceptions being participants with adequately treated non-melanomatous skin carcinoma; participants with other malignancies which have been successfully treated ≥10 years prior to the pretrial (screening) visit; or participants who, in the opinion of the trial investigator, are highly unlikely to sustain a recurrence for the duration of the trial.
- Has blood coagulation test (activated partial thromboplastin time [aPTT], prothrombin time [PT]) ≥ 20 % outside of normal range on pretrial (screening), which are considered clinically significant by both the investigator and the sponsor.
- Any other clinically significant abnormalities in laboratory test results at screening that would, in the opinion of the investigator, increase the participant's risk of participation, jeopardize complete participation in the study, or compromise interpretation of study data.
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-2060Part 1: Single doses (8 mg, 20 mg, or 40 mg) of MK-2060 will be administered via IV infusion on Day 1. Part 2: Three doses of 25 mg of MK- 2060 administered via IV infusion on Days 1, 3 and 5; Followed by single doses of 25 mg of MK-2060 administered via IV infusion on Days 8, 15, and 22. | Drug | Part 1: Panel A- MK-2060 (8 mg), Part 1: Panel B- MK-2060 (20 mg), Part 1: Panel C- MK-2060 (40 mg), Part 2: MK-2060 25-mg Loading/ 25-mg Maintenance |
| PlaceboPart 1: Single dose of placebo will be administered via IV infusion on Day 1. Part 2: Three doses of placebo administered via IV infusion on Days 1, 3 and 5; Followed by single doses of placebo administered via IV infusion on Days 8, 15, and 22. | Drug | Part 1: Placebo, Part 2: Placebo |
Primary outcome
Part 1: Percentage of Participants With Any Adverse Event (AE)
Time frame: Up to 164 days
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. The percentage of participants that experienced an AE was summarized.
Part 2: Percentage of Participants With Any AE
Time frame: Up to 118 days
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. The percentage of participants who experienced an AE was summarized.
Part 1: Percentage of Participants With Any Serious Adverse Event
Time frame: Up to 164 days
A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants who experienced an SAE was summarized.
Part 2: Percentage of Participants With Any SAE
Time frame: Up to 118 days
An SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants who experienced an SAE was summarized.
Part 1: Percentage of Participants With a Systemic AE
Time frame: Up to 164 days
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. The solicited systemic AEs assessed included but not limited to fever, vital sign (VS) changes (tachycardia/hypotension), pruritis, urticarial (hives), lip swelling, angioedema, bronchospasm, stridor, hoarseness, and shortness of breath.
Part 2: Percentage of Participants With a Systemic AE
Time frame: Up to 118 days
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. The solicited systemic AEs assessed included but not limited to fever, vital sign (VS) changes (tachycardia/hypotension), pruritis, urticarial (hives), lip swelling, angioedema, bronchospasm, stridor, hoarseness, and shortness of breath.
Part 1: Percentage of Participants With an Injection-Site AE
Time frame: Up to 164 days
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. The solicited injection-site AEs assessed were pain, tenderness, erythema/redness, and induration/swelling.
Part 2: Percentage of Participants With an Injection-Site AE
Time frame: Up to 118 days
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. The solicited injection-site AEs assessed were pain, tenderness, erythema/redness, and induration/swelling.
Part 1: Percentage of Participants Discontinuing the Study Due to an AE
Time frame: Up to 164 days
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. The percentage of participants that discontinued the study due to an AE was summarized.
Part 2: Percentage of Participants Discontinuing Study Drug Due to an AE
Time frame: Up to 4 weeks
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. The percentage of participants that had study drug discontinued regardless of study completion status was summarized.
14 secondary outcomes
Part 1: Area Under the Plasma Concentration-Time Curve of MK-2060 From 0 to Infinity (AUC0-inf)
Time frame: Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdose, then Days 12, 15, 22, 29, 60, 90, 120, 150
Part 1: Area Under the Plasma Concentration-Time Curve of MK-2060 From Time 0 to 168 Hours (AUC0-168)
Time frame: Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdose
Part 1: Maximum Observed Plasma Concentration (Cmax) of MK-2060
Time frame: Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdose, then Days 12, 15, 22, 29, 60, 90, 120, 150
Part 1: Plasma Concentration of MK-2060 at 168 Hours (C168)
Time frame: 168 hours post dose
Part 1: Time to Maximum Observed Plasma Drug Concentration (Tmax) of MK-2060
Time frame: Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdose
Part 1: Plasma Elimination Terminal Half-life (t ½) of MK-2060
Time frame: Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdose
Part 1: Plasma Clearance (CL) of MK-2060
Time frame: Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdose
Part 1: Plasma Volume of Distribution (Vz) of MK-2060
Time frame: Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdose
Part 2: AUC0-168 of MK-2060
Time frame: Up to 168 hours on Day 1 and Day 22
Part 2: Cmax of MK-2060
Time frame: Day 1 and Day 22
Part 2: C168 of MK-2060
Time frame: 168 hours post dose on Days 1 and 22
Part 2: Tmax of MK-2060
Time frame: Day 1 and Day 22
Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060: Part 1
Time frame: Baseline and 168 hours post-dose (Day 8)
Fold Change From Baseline in aPTT of MK-2060: Part 2
Time frame: Baseline and Day 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
3 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 Renal Dialysis and Kidney Failure, Chronic, run by Merck Sharp & Dohme LLC at 3 sites in United States.
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 8 inclusion and 23 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 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 6 Jun 2024). 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?
Part 1: Percentage of Participants With Any Adverse Event (AE) (time frame: Up to 164 days). The study lists 10 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 6 Jun 2024.