At a glance
ClinicalIndex Comparison Record- ✓Age ≥40 and ≤80 years for Part 1; age ≥18 and ≤80 years for Part 2
- ✓End-stage renal disease maintained on stable outpatient hemodialysis for >3 months with established, functioning AV fistula or graft
- ✓Kt/V ≥1.2 within 3 months prior to dosing
- ✓HD regimen at least 3 times per week for minimum of 3 hours per session, expected to continue throughout study and for ≥3 months beyond
- ✕History of cancer (malignancy) except adequately treated non-melanomatous skin carcinoma or other malignancies successfully treated ≥10 years prior
- ✕History of deep vein thrombosis, pulmonary embolism, or vascular access thrombosis within 1 month prior to enrollment
- ✕History of gastrointestinal bleeding, duodenal polyps, 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.
Single and Multiple Dose Clinical Trial to Study the Safety and Pharmacokinetics of MK-2060 in Older Participants With End-Stage Renal Disease on Hemodialysis
In Brief
A Phase 1 clinical trial evaluating MK-2060 and Placebo for Renal Dialysis and Kidney Failure, Chronic. Completed, enrolled 38 participants across 3 sites.
Detailed Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-2060 after intravenous (IV) administration of single and multiple doses in older adult participants with end-stage renal disease (ESRD) on hemodialysis (HD).
Study Details
Timeline
Interventions
Part 1: Single doses (8 mg, 20 mg, or 40 mg) of MK-2060 will be administered via IV infusion on Day 1. Part 2: Three doses of 25 mg of MK- 2060 administered via IV infusion on Days 1, 3 and 5; Followed by single doses of 25 mg of MK-2060 administered via IV infusion on Days 8, 15, and 22.
Part 1: Single dose of placebo will be administered via IV infusion on Day 1. Part 2: Three doses of placebo administered via IV infusion on Days 1, 3 and 5; Followed by single doses of placebo administered via IV infusion on Days 8, 15, and 22.