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Nucleoside Analog

Molnupiravir for Kidney Failure

Phase 1
Waitlist Available
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at designated time points (up to 72 hours)
Awards & highlights

Study Summary

This trial will study the effects of a single dose of molnupiravir on people with severe renal impairment, comparing them to a control group of healthy people. The trial will also assess the safety and tolerability of molnupiravir in participants with severe renal impairment and study the urinary excretion of N-hydroxycytidine (a metabolite of molnupiravir) in participants with severe renal impairment compared to the control group.

Eligible Conditions
  • Kidney Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at designated time points (up to 72 hours)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at designated time points (up to 72 hours) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Curve From Time 0 to Infinity (AUC0-inf) of N-hydroxycytidine (NHC)
Maximum Plasma Concentration (Cmax) of NHC
Secondary outcome measures
Amount of dose administered excreted in urine (Ae) of N-hydroxycytidine (NHC)
Fraction of the dose administered excreted in urine (Fe) of NHC
Number of Participants who Experienced an Adverse Event (AE)
+1 more

Side effects data

From 2022 Phase 2 & 3 trial • 1735 Patients • NCT04575597
4%
Diarrhoea
4%
COVID-19
1%
COVID-19 pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1: MK-4482 200 mg
Part 1: MK-4482 400 mg
Part 1: MK-4482 800 mg
Part 1: Placebo
Part 2: MK-4482 800 mg
Part 2: Placebo

Trial Design

2Treatment groups
Experimental Treatment
Group I: Panel B - Healthy Control GroupExperimental Treatment1 Intervention
Participants in the healthy mean matched control group will receive a single oral 800 mg dose of molnupiravir.
Group II: Panel A - Severe Renal Impairment GroupExperimental Treatment1 Intervention
Participants with severe renal impairment will receive a single oral 800 mg dose of molnupiravir.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Molnupiravir
2022
Completed Phase 3
~4360

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,908 Previous Clinical Trials
5,066,630 Total Patients Enrolled
1 Trials studying Kidney Failure
8 Patients Enrolled for Kidney Failure
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,789 Previous Clinical Trials
8,067,288 Total Patients Enrolled
~5 spots leftby Jun 2025
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