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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
3,886 Previous Clinical Trials
5,054,531 Total Patients Enrolled
1 Trials studying Kidney Failure
8 Patients Enrolled for Kidney Failure
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,464 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals is the research team monitoring in this clinical trial?

"Affirmative. Per the information on clinicaltrials.gov, this trial is currently looking for candidates. The research was first listed on June 29th 2022 and its details were last amended on November 3rd 2022. 18 subjects need to be recruited from 5 distinct sites."

Answered by AI

How reliable is Molnupiravir in terms of patient safety?

"The safety profile of Molnupiravir is assessed as a 1, owing to the fact that this trial is in its first stage and there has been comparatively little research into both efficacy and safety."

Answered by AI

Are there any healthcare facilities executing this research in North America?

"Currently, the trial is operational at 5 sites in areas such as Hallandale Beach, Miami and Philadelphia. So that participants can reduce transportation costs, it is advised to select a site nearby one's residence."

Answered by AI

Are applicants being accepted for the trial at this time?

"Yes, the information on clinicaltrials.gov shows that this research is currently looking for participants. It was initially listed on June 29th 2022 and its most recent update occured November 3rd of the same year. This study requires 18 individuals to be recruited from 5 sites."

Answered by AI

Does the age of 45 constitute an upper boundary for eligibility in this clinical experiment?

"This study is seeking participants aged eighteen and over, but under seventy-five years of age."

Answered by AI

What are the key goals this research is attempting to achieve?

"The primary objective of this research, which will be evaluated over a period up to 72 hours, is the N-hydroxycytidine (NHC) Area Under the Curve From Time 0 to Infinity (AUC0-inf). Secondary outcomes include determining the Number of Participants who Experienced an Adverse Event (AE); Renal Clearance (CLr) and Fraction of Dose Administered Excreted in Urine (Fe) of NHC."

Answered by AI

May I partake in this scientific experiment?

"This clinical study is open to 18 individuals aged between 18 and 75 with chronic kidney disease. Candidates must also meet the following requirements: a BMI of at least 18.5kg/m^2 but no higher than 35 kg/m^2, for healthy participants their estimated glomerular filtration rate (eGFR) should be 90mL/min or greater according to CKD-EPI Creatinine equation 2021, meanwhile severe renal impairment participants’ eGFR has to be lower than 30 mL/min based on the same reference."

Answered by AI
~6 spots leftby Apr 2025