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Molnupiravir for Kidney Failure
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.
- Kidney Failure
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 2 & 3 trial • 1735 Patients • NCT04575597Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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