drugset / Trial / NCT05656040

A Study of MK-2060 in Participants With Chronic and/or End-Stage Kidney Disease (MK-2060-011)

NCT05656040 ↗

Phase 1 Completed 14 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2023-02-08
Primary completion
2024-08-12
Completion
2024-08-12

Drugs

EvaluationDrugModalityDoseRoute
Subject MK-2060 Monoclonal antibody 30 mg Subcutaneous