End-Stage Renal DiseasePhase 1NCT05656040
A Study of MK-2060 in Participants With Chronic and/or End-Stage Kidney Disease (MK-2060-011)
A Phase 1 study testing MK-2060 in people with End-Stage Renal Disease and End-Stage Kidney Disease, run by Merck Sharp & Dohme LLC at 4 sites in United States.
Trial summary
This was intended as a three-part study of MK-2060 in participants with chronic and/or end-stage kidney disease (Parts 2 and 3 were not initiated due to reasons not related to safety). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- End-Stage Renal Disease, End-Stage Kidney Disease, 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
- 14 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Feb 2023to 12 Aug 2024
- Phase
- Phase 1
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
- At the time of screening, has stage 4 or 5 chronic kidney disease (Parts 1 and 2) or end-state kidney disease on peritoneal dialysis (Part 3).
- Has a body mass index (BMI) ≥ 18 and ≤ 45 kg/m^2.
Who cannot join
- Has a history of cancer, including adenocarcinoma, except adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix or other malignances which have been successfully treated ≥ 5 years prior to prestudy with appropriate follow-up.
- Has a history of deep vein thrombosis or pulmonary embolism, a history of vascular access thrombosis within 1 month prior to enrollment, or has a personal or family history of bleeding disorder.
- Has a history of gastrointestinal (GI) bleeding, duodenal polyps, or gastric ulcer in the last 5 years or severe hemorrhoidal bleed in the last 3 months.
- Has a history of or current frequent epistaxis within the last 3 months or active gingivitis.
- Has ongoing anticoagulant therapy or antiplatelet therapy. Aspirin is permitted.
- Has planned significant dental procedures at the time of screening or pre-dose or other planned surgical procedures within duration of participation of study.
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- Is positive for hepatitis B surface antigen or human immunodeficiency virus (HIV).
- Has had major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the pre-study visit.
- Has a history (participant recall) of receiving any human immunoglobulin preparation such as intravenous immunoglobulin (IVIG) or RhoGAM within the last year.
- Has a history (participant recall) of receiving any biological therapy (including human blood products or monoclonal antibodies; excluding erythropoietin and insulin) within the last 3 months or vaccination within the last 1 month, except the seasonal flu and pneumococcal vaccine or COVID-19 vaccine.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Velocity Clinical Research, New Smyrna Beach ( Site 0003)
Edgewater, Florida, 32132
Alliance for Multispecialty Research, LLC ( Site 0002)
Knoxville, Tennessee, 37920
Advanced Pharma CR, LLC ( Site 0006)
Miami, Florida, 33147
Genesis Clinical Research, LLC ( Site 0004)
Tampa, Florida, 33603
About this study
Official title: A Single-and Multiple Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Subcutaneous MK-2060 in Participants With Chronic and/or End-Stage Kidney Disease
This was intended as a three-part study of MK-2060 in participants with chronic and/or end-stage kidney disease (Parts 2 and 3 were not initiated due to reasons not related to safety). The purpose of Part 1 of the study was to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single subcutaneous dose of MK-2060 in stage 4 chronic kidney disease (CKD4) [Part2 was intended to evaluate multiple subcutaneous doses in CKD4 participants and Part 3 was intended to evaluate a single subcutaneous dose of MK-2060 in participants with end-stage kidney disease (ESRD)]. The primary hypothesis for Part 1 was that the true geometric mean of the area under the concentration-time curve from 0 to infinity (AUC0-inf) after a single-dose of MK-2060 in adult CKD4 participants would be at least 11300 nM*hr.
- 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
MK-2060 lyophilized powder diluted in normal saline and administered subcutaneously
PlaceboDrug
Normal saline administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| MK-2060 30 mg | Experimental | Participants received MK-2060 30 mg administered as a single subcutaneous dose on Day 1. Receives: Biological: MK-2060 |
| Placebo | Placebo comparator | Participants received placebo (normal saline) administered as a single subcutaneous dose on Day 1. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Participants Who Experience One or More Bleeding Related Adverse Events (AE)
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.
Measured: Up to approximately 104 days
Part 2: Number of Participants Who Experience One or More Bleeding Related AEs
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.
Measured: Up to approximately 144 days
Part 3: Number of Participants Who Experience One or More Bleeding Related AEs
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.
Measured: Up to approximately 104 days
Part 1: Number of Participants Who Experience One or More AEs
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.
Measured: Up to approximately 104 days
Part 2: Number of Participants Who Experience One or More AEs
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.
Measured: Up to approximately 144 days
Part 3: Number of Participants Who Experience One or More AEs
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.
Measured: Up to approximately 104 days
Part 1: Number of Participants Who Discontinue Study Treatment 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. 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.
Measured: Up to approximately 104 days
Part 2: Number of Participants Who Discontinue Study Treatment 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. 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.
Measured: Up to approximately 144 days
Part 3: Number of Participants Who Discontinue 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. 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.
Measured: Up to approximately 104 days
Part 1: Area Under the Concentration-Time Curve From 0 to Infinity (AUC0-inf) of MK-2060
Blood was collected to determine the AUC0-inf of MK-2060 in plasma.
Measured: Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and 90 post-dose
Part 2: AUC0-inf of MK-2060
Blood was to be collected at pre-specified time points to determine the AUC0-inf of MK-2060 in plasma.
Measured: Days 1, 2, 4, 8, 15, and 22: pre-dose; once daily on Days 10, 17, 26, 29, 35, 42, 49, 63, 81, 111, and 130 post-dose
Part 3: AUC0-inf of MK-2060
Blood was to be collected at pre-specified time points to determine the AUC0-inf of MK-2060 in plasma.
Measured: Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 42, 60, 90, and 120 post-dose
Part 1: Area Under the Concentration-Time Curve From Time 0 to 168 Hours (AUC0-168) of MK-2060
Blood was collected to determine the AUC0-168 of MK-2060 in plasma.
Measured: Pre-dose, 1, 12, 24, 48, 120, and 168 hours post-dose
Part 2: AUC0-168 of MK-2060
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.
Measured: Pre-dose, 24, 72, and 168 hours post-dose
Part 3: AUC0-168 of MK-2060
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.
Measured: Pre-dose, 1, 12, 24, 48, 120, and 168 hours post-dose
Part 1: Maximum Plasma Concentration (Cmax) of MK-2060
Blood was collected at pre-specified time points to determine the Cmax of MK-2060 in plasma.
Measured: Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and 90 post-dose
Part 2: Cmax of MK-2060
Blood was to be collected at pre-specified time points to determine the Cmax of MK-2060 in plasma.
Measured: Days 1, 2, 4, 8, 15, and 22: pre-dose; once daily on Days 10, 17, 26, 29, 35, 42, 49, 63, 81, 111, and 130 post-dose
Part 3: Cmax of MK-2060
Blood was to be collected at pre-specified time points to determine the Cmax of MK-2060 in plasma.
Measured: Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 42, 60, 90, and 120 post-dose
Part 1: Plasma Concentration at 168 Hours (C168) of MK-2060
Blood was collected at 168 hours post-dose to determine the C168 of MK-2060 in plasma.
Measured: 168 hours post-dose
Part 2: C168 of MK-2060
Blood was to be collected at 168 hours post-dose to determine the C168 of MK-2060 in plasma.
Measured: 168 hours post-dose
Part 3: C168 of MK-2060
Blood was to be collected at 168 hours post-dose to determine the C168 of MK-2060 in plasma.
Measured: 168 hours post-dose
Part 1: Time to Maximum Plasma Concentration (Tmax) of MK-2060
Blood was collected at pre-specified time points to determine the Tmax of MK-2060 in plasma.
Measured: Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and 90 post-dose
Part 2: Tmax of MK-2060
Blood was to be collected at pre-specified time points to determine the Tmax of MK-2060 in plasma.
Measured: Days 1, 2, 4, 8, 15, and 22: pre-dose; once daily on Days 10, 17, 26, 29, 35, 42, 49, 63, 81, 111, and 130 post-dose
Part 3: Tmax of MK-2060
Blood was to be collected at pre-specified time points to determine the Tmax of MK-2060 in plasma.
Measured: Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 42, 60, 90, and 120 post-dose
Part 1: Terminal Half Life (t1/2) of MK-2060
Blood was collected at pre-specified time points to determine the terminal t1/2 of MK-2060 in plasma.
Measured: Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and 90 post-dose
Part 2: t1/2 of MK-2060
Blood was to be collected at pre-specified time points to determine the terminal t1/2 of MK-2060 in plasma.
Measured: Days 1, 2, 4, 8, 15, and 22: pre-dose; once daily on Days 10, 17, 26, 29, 35, 42, 49, 63, 81, 111, and 130 post-dose
Part 3: t1/2 of MK-2060
Blood was to be collected at pre-specified time points to determine the terminal t1/2 of MK-2060 in plasma.
Measured: Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 42, 60, 90, and 120 post-dose
Part 1: Apparent Total Clearance (CL/F) of MK-2060
Blood was collected at pre-specified time points to determine the CL/F of MK-2060 in plasma.
Measured: Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and 90 post-dose
Part 2: CL/F of MK-2060
Blood was to be collected at pre-specified time points to determine the CL/F of MK-2060 in plasma.
Measured: Days 1, 2, 4, 8, 15, and 22: pre-dose; once daily on Days 10, 17, 26, 29, 35, 42, 49, 63, 81, 111, and 130 post-dose
Part 3: CL/F of MK-2060
Blood was to be collected at pre-specified time points to determine the CL/F of MK-2060 in plasma.
Measured: Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 42, 60, 90, and 120 post-dose
Part 1: Apparent Volume of Distribution (Vz/F) of MK-2060
Blood was collected at pre-specified time points to determine the Vz/F of MK-2060 in plasma
Measured: Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and 90 post-dose
Part 2: Vz/F of MK-2060
Blood was to be collected at pre-specified time points to determine the Vz/F of MK-2060 in plasma
Measured: Days 1, 2, 4, 8, 15, and 22: pre-dose; once daily on Days 10, 17, 26, 29, 35, 42, 49, 63, 81, 111, and 130 post-dose
Part 3: Vz/F of MK-2060
Blood was to be collected at pre-specified time points to determine the Vz/F of MK-2060 in plasma
Measured: Day 1: pre-dose, 1 and 12 hours post-dose; once daily on Days 2, 3, 6, 8, 11, 14, 21, 28, 42, 60, 90, and 120 post-dose
Secondary outcomes (3)
Part 1: Mean Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060
Blood was collected at pre-specified time points to determine the aPTT of MK-2060 in plasma. Positive and negative scores indicate increases and decreases, respectively, in aPTT compared to baseline.
Measured: Day 1 (1 hr and 12 hrs postdose) and Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and Post Study (Day 90)
Part 2: Percent Change From Baseline in aPTT of MK-2060
Blood was to be collected at pre-specified time points to determine the aPTT of MK-2060 in plasma.
Measured: Day 1 (1 hr and 12 hrs postdose) and Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and Post Study (Day 90)
Part 3: Percent Change From Baseline in aPTT of MK-2060
Blood was to be collected at pre-specified time points to determine the aPTT of MK-2060 in plasma.
Measured: Day 1 (1 hr and 12 hrs postdose) and Days 2, 3, 6, 8, 11, 14, 21, 28, 60, and Post Study (Day 90)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start8 Feb 2023
- Primary completion12 Aug 2024
- Study completion12 Aug 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 DiseaseStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 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
- NCT05656040
- Sponsor's protocol ID
- 2060-011
- Other IDs
- MK-2060-011
- Status last verified
- Sep 2025
- First submitted
- 9 Dec 2022
- Last updated
- 10 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf