A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients
NCT ID: NCT04294472
Last Updated: 2023-06-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2020-08-05
2022-02-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Cohort 1
Cohort 1: MAU868 1350 mg IV approximately every 28 days for a total of 4 doses
MAU868
MAU868 is a human monoclonal antibody (IgG1) that binds the viral capsid protein, VP1, that is responsible for binding to the surface of host cells
Cohort 2
Cohort 2: MAU868 6750 mg IV on Study Day 1 and then 1350 mg IV approximately every 28 days for a total of 4 doses
MAU868
MAU868 is a human monoclonal antibody (IgG1) that binds the viral capsid protein, VP1, that is responsible for binding to the surface of host cells
Cohort 3
Cohort 3: MAU868 6750 mg IV approximately every 28 days for a total of 4 doses
MAU868
MAU868 is a human monoclonal antibody (IgG1) that binds the viral capsid protein, VP1, that is responsible for binding to the surface of host cells
Placebo Cohort 1, 2, 3
5% dextrose in water \[D5W\] IV delivered every 28 days for a total of 4 doses
Placebo
250 mL D5W placebo IV to be labeled to match that of MAU868
Interventions
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MAU868
MAU868 is a human monoclonal antibody (IgG1) that binds the viral capsid protein, VP1, that is responsible for binding to the surface of host cells
Placebo
250 mL D5W placebo IV to be labeled to match that of MAU868
Eligibility Criteria
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Inclusion Criteria
* Recipient of a kidney (or kidney-pancreas) transplant within the year prior to enrollment
* Documented BKV viremia based on local or central laboratory testing within 10 days
Exclusion Criteria
* A BKV plasma viral load of ≥ 10\^7 copies/mL.
18 Years
ALL
No
Sponsors
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Vera Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Yale University
New Haven, Connecticut, United States
University of Kentucky
Lexington, Kentucky, United States
The Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Washington University
St Louis, Missouri, United States
Montefiore Medical Center
The Bronx, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Renal Disease Research Institute, LLC
Dallas, Texas, United States
The University of Texas Southwester Medical Center
Dallas, Texas, United States
Houston Methodist Research Institute
Houston, Texas, United States
University of Washington
Seattle, Washington, United States
University Health Network
Toronto, Ontario, Canada
Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l'Est de-l'Île-de-Montréal
Montreal, Quebec, Canada
The Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada
Countries
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References
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Wajih Z, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD013344. doi: 10.1002/14651858.CD013344.pub2.
Helle F, Aubry A, Morel V, Descamps V, Demey B, Brochot E. Neutralizing Antibodies Targeting BK Polyomavirus: Clinical Importance and Therapeutic Potential for Kidney Transplant Recipients. J Am Soc Nephrol. 2024 Oct 1;35(10):1425-1433. doi: 10.1681/ASN.0000000000000457. Epub 2024 Jul 9.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MAU868-201
Identifier Type: -
Identifier Source: org_study_id
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