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A PHASE 1, OPEN-LABEL, NON-RANDOMIZED STUDY TO INVESTIGATE THE SAFETY AND PK FOLLOWING MULTIPLE ORAL DOSES OF PF-07321332 (NIRMATRELVIR)/RITONAVIR IN ADULT PARTICIPANTS WITH COVID-19 AND SEVERE RENAL IMPAIRMENT EITHER ON HEMODIALYSIS OR NOT ON HEMODIALYSIS
The purpose of this study is to learn about the side effects (safety) of the study medicine PF-07321332 (nirmatrelvir)/ritonavir for the treatment of mild to moderate COVID-19 infection in adults with severe renal impairment. The study will also look at the amounts of study drug in your blood. There will be 24 participants in this study; 12 of them will have severe renal impairment and not be on hemodialysis and 12 of them will be on hemodialysis. All participants in this study will take PF-07321332 (nirmatrelvir)/ritonavir by mouth for 5 days. During this time, they will have to collect blood samples to measure the study drug levels in their blood. After taking the study drug for 5 days, the participants will have follow-up visits for about another 28 days for a total of about 34 days in the study. The study team will check how each participant is doing during regular visits at the study clinic.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Fresenius Kidney Care Huntsville
Huntsville, Alabama, United States
Fresenius Kidney Care Rocket City
Huntsville, Alabama, United States
Apogee Clinical Research, LLC
Huntsville, Alabama, United States
Nephrology Consultants
Huntsville, Alabama, United States
Fresenius Kidney Care Chase
Huntsville, Alabama, United States
Fresenius Kidney Care Endeavour
Huntsville, Alabama, United States
Fresenius Kidney Care Parkway
Huntsville, Alabama, United States
Amicis Research Center - Granada Hills
Granada Hills, California, United States
Amicis Research Center
Granada Hills, California, United States
DaVita Inglewood Dialysis
Inglewood, California, United States
Start Date
September 7, 2022
Primary Completion Date
July 11, 2023
Completion Date
July 11, 2023
Last Updated
September 23, 2024
15
ACTUAL participants
PF-07321332 (nirmatrelvir)/ritonavir
DRUG
Lead Sponsor
Pfizer
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06631287