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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 is a Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 14 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05656040
The ClinicalTrials.gov registry entry for NCT05656040 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05656040 reports 0 study locations.
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.
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