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A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease

Primary Purpose

COVID-19

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PF-07321332 (nirmatrelvir)/ritonavir
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2), kidney disease, kidney failure, renal disease, renal failure, dialysis, renal dialysis, hemodialysis, coronavirus disease 2019 (COVID-19), COVID, Paxlovid, antiviral, nirmatrelvir, mild to moderate COVID-19, high risk

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Covid-19 infection
  • Severe kidney disease (on hemodialysis or not on hemodialysis)

Exclusion Criteria:

  • Hospitalized
  • Take medications that are not allowed
  • Renal transplant patients
  • HIV infection

This is not a complete list. Other inclusion and exclusion criteria may apply.

Sites / Locations

  • Fresenius Kidney Care HuntsvilleRecruiting
  • Fresenius Kidney Care Rocket CityRecruiting
  • Apogee Clinical Research, LLCRecruiting
  • Nephrology ConsultantsRecruiting
  • Fresenius Kidney Care ChaseRecruiting
  • Fresenius Kidney Care EndeavourRecruiting
  • Fresenius Kidney Care ParkwayRecruiting
  • Amicis Research Center - Granada HillsRecruiting
  • Amicis Research CenterRecruiting
  • DaVita Inglewood Dialysis
  • Northridge Kidney CenterRecruiting
  • Clinnova Research - Redondo Beach
  • Santa Clarita DialysisRecruiting
  • laurel Canyon DialysisRecruiting
  • Desert Cities DiaylsisRecruiting
  • Desert Cities Dialysis - HesperiaRecruiting
  • Fresenius Kidney Care Ft Lauderdale #2036Recruiting
  • South Florida Research InstituteRecruiting
  • Fresenius Kidney Care Florida Kidney Center #1095Recruiting
  • GCP Research, Global Clinical professionalsRecruiting
  • Fresenius Kidney Care Tamarac-JV #6606Recruiting
  • Fresenius Kidney Care Hillsborough #100706Recruiting
  • Genesis Clinical Research, LLCRecruiting
  • Fresenius Kidney Care Tampa #1130Recruiting
  • Fresenius Kidney Care Ybor City #1863Recruiting
  • Fresenius Kidney Care Town and Country #100474Recruiting
  • Fresenius Kidney Care Carrollwood #1805Recruiting
  • Fresenius Kidney Care- CaldwellRecruiting
  • Fresenius Kidney Care-MeridianRecruiting
  • Liberty Dialysis- NampaRecruiting
  • Boise Kidney & Hypertension InstituteRecruiting
  • Swedish Covenant HospitalRecruiting
  • NorthShore University HealthSystem - Evanston HospitalRecruiting
  • DaVita Evanston Renal CenterRecruiting
  • DaVita Glen DialysisRecruiting
  • NorthShore University HealthSystem - Glenbrook HospitalRecruiting
  • NorthShore University HealthSystem - Highland Park HospitalRecruiting
  • NorthShore University HealthSystem - Skokie HospitalRecruiting
  • NorthShore Immediate Care Center - Skokie at Old Orchard WoodsRecruiting
  • NorthShore University HealthSystem - Clinical Trials CenterRecruiting
  • Piedmont Dialysis CenterRecruiting
  • Brookview Hills Research AssociatesRecruiting
  • Northside Dialysis CenterRecruiting
  • Fresenius Kidney Care / Roane County #2829Recruiting
  • Fresenius Kidney Care / Fort Sanders #1597Recruiting
  • Fresenius Kidney Care / Cedar Bluff #6942Recruiting
  • Knoxville Kidney Center, PLLCRecruiting
  • Arlington NephrologyRecruiting
  • South Arlington Dialysis CenterRecruiting
  • Grand Prairie Dialysis CenterRecruiting
  • University of Virginia Health SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PF-07321332 (nirmatrelvir)/ritonavir participants with severe renal impairment on hemodialysis

PF-07321332 (nirmatrelvir)/ritonavir participants with severe renal impairment not on hemodialysis

Arm Description

Patients with Covid-19 infection and severe renal impairment. Capsule and tablet once a day by mouth.

Patients with Covid-19 infection and severe renal impairment. Capsule and tablet once a day by mouth.

Outcomes

Primary Outcome Measures

Number of Participants With Treatment Emergent AEs and SAEs (TEAEs)
Number of Participants With Permanent Treatment Discontinuation Due to Adverse Events and Serious Adverse Events

Secondary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) of PF-07321332 (nirmatrelvir)
Apparent Oral Clearance (CL/F) of PF-07321332 (nirmatrelvir)
Apparent Volume of Distribution (Vz/F) of PF-07321332 (nirmatrelvir)
Area Under the Curve from Time Zero to end of dosing interval (AUC 0-tau) PF-07321332 (nirmatrelvir)
Plasma Decay Half-Life (t1/2) of PF-07321332 (nirmatrelvir)
Pre-dose Plasma Concentration (Ctrough) of PF-07321332 (nirmatrelvir)
Dialyzer Clearance (CLd) (nirmatrelvir)
Fraction of drug removed during dialysis (Fd) (nirmatrelvir)

Full Information

First Posted
August 2, 2022
Last Updated
May 3, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05487040
Brief Title
A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2022 (Actual)
Primary Completion Date
August 4, 2023 (Anticipated)
Study Completion Date
August 4, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2), kidney disease, kidney failure, renal disease, renal failure, dialysis, renal dialysis, hemodialysis, coronavirus disease 2019 (COVID-19), COVID, Paxlovid, antiviral, nirmatrelvir, mild to moderate COVID-19, high risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PF-07321332 (nirmatrelvir)/ritonavir participants with severe renal impairment on hemodialysis
Arm Type
Experimental
Arm Description
Patients with Covid-19 infection and severe renal impairment. Capsule and tablet once a day by mouth.
Arm Title
PF-07321332 (nirmatrelvir)/ritonavir participants with severe renal impairment not on hemodialysis
Arm Type
Experimental
Arm Description
Patients with Covid-19 infection and severe renal impairment. Capsule and tablet once a day by mouth.
Intervention Type
Drug
Intervention Name(s)
PF-07321332 (nirmatrelvir)/ritonavir
Other Intervention Name(s)
Paxlovid
Intervention Description
Patients with Covid-19 infection and severe renal impairment. Capsule and tablet once a day by mouth.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent AEs and SAEs (TEAEs)
Time Frame
Through Day 34
Title
Number of Participants With Permanent Treatment Discontinuation Due to Adverse Events and Serious Adverse Events
Time Frame
Through Day 34
Secondary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax) of PF-07321332 (nirmatrelvir)
Time Frame
Treatment Day 1 to Day 5
Title
Apparent Oral Clearance (CL/F) of PF-07321332 (nirmatrelvir)
Time Frame
Treatment Day 1 to Day 5
Title
Apparent Volume of Distribution (Vz/F) of PF-07321332 (nirmatrelvir)
Time Frame
Treatment Day 1 to Day 5
Title
Area Under the Curve from Time Zero to end of dosing interval (AUC 0-tau) PF-07321332 (nirmatrelvir)
Time Frame
Treatment Day 1 to Day 5
Title
Plasma Decay Half-Life (t1/2) of PF-07321332 (nirmatrelvir)
Time Frame
Treatment Day 1 to Day 5
Title
Pre-dose Plasma Concentration (Ctrough) of PF-07321332 (nirmatrelvir)
Time Frame
Treatment Day 1 to Day 5
Title
Dialyzer Clearance (CLd) (nirmatrelvir)
Time Frame
0 Hour to approximately 4 Hours
Title
Fraction of drug removed during dialysis (Fd) (nirmatrelvir)
Time Frame
0 Hour to approximately 4 Hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Covid-19 infection Severe kidney disease (on hemodialysis or not on hemodialysis) Exclusion Criteria: Hospitalized Take medications that are not allowed Renal transplant patients HIV infection This is not a complete list. Other inclusion and exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Fresenius Kidney Care Huntsville
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Individual Site Status
Recruiting
Facility Name
Fresenius Kidney Care Rocket City
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35802
Country
United States
Individual Site Status
Recruiting
Facility Name
Apogee Clinical Research, LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Individual Site Status
Recruiting
Facility Name
Nephrology Consultants
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Individual Site Status
Recruiting
Facility Name
Fresenius Kidney Care Chase
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35810
Country
United States
Individual Site Status
Recruiting
Facility Name
Fresenius Kidney Care Endeavour
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35816
Country
United States
Individual Site Status
Recruiting
Facility Name
Fresenius Kidney Care Parkway
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35816
Country
United States
Individual Site Status
Recruiting
Facility Name
Amicis Research Center - Granada Hills
City
Granada Hills
State/Province
California
ZIP/Postal Code
91344
Country
United States
Individual Site Status
Recruiting
Facility Name
Amicis Research Center
City
Granada Hills
State/Province
California
ZIP/Postal Code
91344
Country
United States
Individual Site Status
Recruiting
Facility Name
DaVita Inglewood Dialysis
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Northridge Kidney Center
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinnova Research - Redondo Beach
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Santa Clarita Dialysis
City
Santa Clarita
State/Province
California
ZIP/Postal Code
91355
Country
United States
Individual Site Status
Recruiting
Facility Name
laurel Canyon Dialysis
City
Sun Valley
State/Province
California
ZIP/Postal Code
91352
Country
United States
Individual Site Status
Recruiting
Facility Name
Desert Cities Diaylsis
City
Victorville
State/Province
California
ZIP/Postal Code
92392
Country
United States
Individual Site Status
Recruiting
Facility Name
Desert Cities Dialysis - Hesperia
City
Victorville
State/Province
California
ZIP/Postal Code
92395
Country
United States
Individual Site Status
Recruiting
Facility Name
Fresenius Kidney Care Ft Lauderdale #2036
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33312
Country
United States
Individual Site Status
Recruiting
Facility Name
South Florida Research Institute
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33313
Country
United States
Individual Site Status
Recruiting
Facility Name
Fresenius Kidney Care Florida Kidney Center #1095
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Individual Site Status
Recruiting
Facility Name
GCP Research, Global Clinical professionals
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Individual Site Status
Recruiting
Facility Name
Fresenius Kidney Care Tamarac-JV #6606
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Individual Site Status
Recruiting
Facility Name
Fresenius Kidney Care Hillsborough #100706
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Individual Site Status
Recruiting
Facility Name
Genesis Clinical Research, LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Individual Site Status
Recruiting
Facility Name
Fresenius Kidney Care Tampa #1130
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Individual Site Status
Recruiting
Facility Name
Fresenius Kidney Care Ybor City #1863
City
Tampa
State/Province
Florida
ZIP/Postal Code
33610
Country
United States
Individual Site Status
Recruiting
Facility Name
Fresenius Kidney Care Town and Country #100474
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Individual Site Status
Recruiting
Facility Name
Fresenius Kidney Care Carrollwood #1805
City
Tampa
State/Province
Florida
ZIP/Postal Code
33624
Country
United States
Individual Site Status
Recruiting
Facility Name
Fresenius Kidney Care- Caldwell
City
Caldwell
State/Province
Idaho
ZIP/Postal Code
83605
Country
United States
Individual Site Status
Recruiting
Facility Name
Fresenius Kidney Care-Meridian
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Individual Site Status
Recruiting
Facility Name
Liberty Dialysis- Nampa
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Individual Site Status
Recruiting
Facility Name
Boise Kidney & Hypertension Institute
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83687
Country
United States
Individual Site Status
Recruiting
Facility Name
Swedish Covenant Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60625
Country
United States
Individual Site Status
Recruiting
Facility Name
NorthShore University HealthSystem - Evanston Hospital
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Individual Site Status
Recruiting
Facility Name
DaVita Evanston Renal Center
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60202
Country
United States
Individual Site Status
Recruiting
Facility Name
DaVita Glen Dialysis
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60026
Country
United States
Individual Site Status
Recruiting
Facility Name
NorthShore University HealthSystem - Glenbrook Hospital
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60026
Country
United States
Individual Site Status
Recruiting
Facility Name
NorthShore University HealthSystem - Highland Park Hospital
City
Highland Park
State/Province
Illinois
ZIP/Postal Code
60035
Country
United States
Individual Site Status
Recruiting
Facility Name
NorthShore University HealthSystem - Skokie Hospital
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Individual Site Status
Recruiting
Facility Name
NorthShore Immediate Care Center - Skokie at Old Orchard Woods
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Individual Site Status
Recruiting
Facility Name
NorthShore University HealthSystem - Clinical Trials Center
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Individual Site Status
Recruiting
Facility Name
Piedmont Dialysis Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27101
Country
United States
Individual Site Status
Recruiting
Facility Name
Brookview Hills Research Associates
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Name
Northside Dialysis Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27105
Country
United States
Individual Site Status
Recruiting
Facility Name
Fresenius Kidney Care / Roane County #2829
City
Harriman
State/Province
Tennessee
ZIP/Postal Code
37748
Country
United States
Individual Site Status
Recruiting
Facility Name
Fresenius Kidney Care / Fort Sanders #1597
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37921
Country
United States
Individual Site Status
Recruiting
Facility Name
Fresenius Kidney Care / Cedar Bluff #6942
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923
Country
United States
Individual Site Status
Recruiting
Facility Name
Knoxville Kidney Center, PLLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923
Country
United States
Individual Site Status
Recruiting
Facility Name
Arlington Nephrology
City
Arlington
State/Province
Texas
ZIP/Postal Code
76015
Country
United States
Individual Site Status
Recruiting
Facility Name
South Arlington Dialysis Center
City
Arlington
State/Province
Texas
ZIP/Postal Code
76015
Country
United States
Individual Site Status
Recruiting
Facility Name
Grand Prairie Dialysis Center
City
Grand Prairie
State/Province
Texas
ZIP/Postal Code
75051
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C4671028
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease

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