CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 14 enrolled
Drug / intervention
Belzutifandrug
Likely dose
Belzutifan 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04994522
NCT04994522Phase 1Completed
CompareCT.gov

An Open-Label, Single-Dose Study to Investigate the Influence of Renal Impairment on the Pharmacokinetics of MK-6482

Merck Sharp & Dohme LLC·interventional·Posted Aug 6, 2021·Updated Apr 6, 2025

In Brief

A Phase 1 clinical trial evaluating Belzutifan for End Stage Renal Disease and Renal Impairment. Completed, enrolled 14 participants across 1 site.

Detailed Summary

The primary purpose of this study is to compare the plasma pharmacokinetics (PK) of belzutifan (MK-6482) following a single oral 120 mg dose in participants with end stage renal disease (ESRD) before and after hemodialysis (HD) to each other and also to that of healthy matched control participants. This study will also evaluate the safety and tolerability of a single oral 120 mg dose of belzutifan in participants with ESRD and the extent of belzutifan removed by HD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEnd Stage Renal Disease, Renal Impairment
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedAug 6, 2021
Enrollment StartJul 12, 2022
Primary CompletionApr 1, 2024
Study CompletionApr 11, 2024
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 4.9 years ago

Interventions

Belzutifandrug

Three 40 mg tablets given as a single oral 120 mg dose.