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NCT05656040 · ClinicalTrials.gov registry record · Phase 1
A Study of MK-2060 in Participants With Chronic and/or End-Stage Kidney Disease (MK-2060-011)
A Phase 1 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT05656040: Completed Phase 1 study, sponsored by Merck Sharp & Dohme.
NCT05656040 is a Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05656040, a Phase 1 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study 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). 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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- BIOLOGICAL MK-2060
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2023-02-08 |
| Est. Completion | 2024-08-12 |
| Phase | Phase 1 |
What the finished NCT05656040 record still lists
NCT05656040 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05656040 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05656040 about?
NCT05656040 is a clinical study titled "A Study of MK-2060 in Participants With Chronic and/or End-Stage Kidney Disease (MK-2060-011)". 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 ...
What is the current status of trial NCT05656040?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2023-02-08. Estimated completion is 2024-08-12.
What interventions are being tested in trial NCT05656040?
The interventions under investigation include: Placebo (DRUG), MK-2060 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05656040?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05656040's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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