At a glance
ClinicalIndex Comparison Record- ✓Stage 4 or 5 chronic kidney disease (Parts 1 and 2) or end-stage kidney disease on peritoneal dialysis (Part 3)
- ✓Body mass index (BMI) between 18 and 45 kg/m²
- ✕History of cancer, except adequately treated non-melanomatous skin carcinoma, carcinoma in situ of cervix, or other malignancies successfully treated ≥5 years prior with appropriate follow-up
- ✕History of deep vein thrombosis, pulmonary embolism, vascular access thrombosis within 1 month, or personal/family history of bleeding disorder
- ✕History of GI bleeding, duodenal polyps, or gastric ulcer in last 5 years, or severe hemorrhoidal bleed in last 3 months
- ✕History of or current frequent epistaxis within last 3 months or active gingivitis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating MK-2060 and Placebo for End-Stage Renal Disease and 2 related conditions. Completed, enrolled 14 participants across 4 sites.
Detailed 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.
Study Details
Timeline
Interventions
MK-2060 lyophilized powder diluted in normal saline and administered subcutaneously
Normal saline administered subcutaneously