A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease
Public ClinicalTrials.gov record NCT05487040. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05487040
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 15 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 7, 2022 (Actual)
- Primary completion
- Jul 11, 2023 (Actual)
- Completion
- Jul 11, 2023 (Actual)
- Last update posted
- Sep 23, 2024
2022 – 2023
United States locations
- U.S. sites
- 52
- U.S. states
- 9
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Fresenius Kidney Care Huntsville | Huntsville | Alabama | 35801 | — |
| Fresenius Kidney Care Rocket City | Huntsville | Alabama | 35802 | — |
| Apogee Clinical Research, LLC | Huntsville | Alabama | 35805 | — |
| Nephrology Consultants | Huntsville | Alabama | 35805 | — |
| Fresenius Kidney Care Chase | Huntsville | Alabama | 35810 | — |
| Fresenius Kidney Care Endeavour | Huntsville | Alabama | 35816 | — |
| Fresenius Kidney Care Parkway | Huntsville | Alabama | 35816 | — |
| Amicis Research Center - Granada Hills | Granada Hills | California | 91344 | — |
| Amicis Research Center | Granada Hills | California | 91344 | — |
| DaVita Inglewood Dialysis | Inglewood | California | 90301 | — |
| Northridge Kidney Center | Northridge | California | 91324 | — |
| Clinnova Research - Redondo Beach | Redondo Beach | California | 90277 | — |
| Santa Clarita Dialysis | Santa Clarita | California | 91355 | — |
| laurel Canyon Dialysis | Sun Valley | California | 91352 | — |
| Desert Cities Diaylsis | Victorville | California | 92392 | — |
| Desert Cities Dialysis - Hesperia | Victorville | California | 92395 | — |
| Fresenius Kidney Care Ft Lauderdale #2036 | Fort Lauderdale | Florida | 33312 | — |
| South Florida Research Institute | Lauderdale Lakes | Florida | 33313 | — |
| Fresenius Kidney Care Florida Kidney Center #1095 | Lauderhill | Florida | 33319 | — |
| GCP Research, Global Clinical professionals | St. Petersburg | Florida | 33705 | — |
| Fresenius Kidney Care Tamarac-JV #6606 | Tamarac | Florida | 33321 | — |
| Fresenius Kidney Care Hillsborough #100706 | Tampa | Florida | 33603 | — |
| Genesis Clinical Research, LLC | Tampa | Florida | 33603 | — |
| Fresenius Kidney Care Tampa #1130 | Tampa | Florida | 33609 | — |
| Fresenius Kidney Care Ybor City #1863 | Tampa | Florida | 33610 | — |
| Fresenius Kidney Care Town and Country #100474 | Tampa | Florida | 33615 | — |
| Fresenius Kidney Care Carrollwood #1805 | Tampa | Florida | 33624 | — |
| Fresenius Kidney Care-Boise | Boise | Idaho | 83702 | — |
| Fresenius Kidney Care- Caldwell | Caldwell | Idaho | 83605 | — |
| Fresenius Kidney Care-Meridian | Meridian | Idaho | 83642 | — |
| Liberty Dialysis- Nampa | Nampa | Idaho | 83686 | — |
| Boise Kidney & Hypertension Institute, PLLC | Nampa | Idaho | 83687 | — |
| Swedish Covenant Hospital | Chicago | Illinois | 60625 | — |
| NorthShore University HealthSystem - Evanston Hospital | Evanston | Illinois | 60201 | — |
| DaVita Evanston Renal Center | Evanston | Illinois | 60202 | — |
| DaVita Glen Dialysis | Glenview | Illinois | 60026 | — |
| NorthShore University HealthSystem - Glenbrook Hospital | Glenview | Illinois | 60026 | — |
| NorthShore University HealthSystem - Highland Park Hospital | Highland Park | Illinois | 60035 | — |
| NorthShore University HealthSystem - Skokie Hospital | Skokie | Illinois | 60076 | — |
| NorthShore Immediate Care Center - Skokie at Old Orchard Woods | Skokie | Illinois | 60077 | — |
| NorthShore University HealthSystem - Clinical Trials Center | Skokie | Illinois | 60077 | — |
| Piedmont Dialysis Center | Winston-Salem | North Carolina | 27101 | — |
| Brookview Hills Research Associates | Winston-Salem | North Carolina | 27103 | — |
| Northside Dialysis Center | Winston-Salem | North Carolina | 27105 | — |
| Fresenius Kidney Care / Roane County #2829 | Harriman | Tennessee | 37748 | — |
| Fresenius Kidney Care / Fort Sanders #1597 | Knoxville | Tennessee | 37921 | — |
| Fresenius Kidney Care / Cedar Bluff #6942 | Knoxville | Tennessee | 37923 | — |
| Knoxville Kidney Center, PLLC | Knoxville | Tennessee | 37923 | — |
| Arlington Nephrology | Arlington | Texas | 76015 | — |
| South Arlington Dialysis Center | Arlington | Texas | 76015 | — |
| Grand Prairie Dialysis Center | Grand Prairie | Texas | 75051 | — |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05487040, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 23, 2024 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05487040 live on ClinicalTrials.gov.